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Category: In the News

May23Viveve Secures $30 million Debt Financing with CRG »


SUNNYVALE, CA -- 05/23/17 -- Viveve Medical, Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today announced that it has entered into a senior credit...

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May12Maxigesic on Track to Access the Large United States Painkiller Market »


AFT Pharmaceuticals has been officially notified that the US Food and Drug Administration (FDA) has accepted its application to register its painkiller Maxigesictablets in the United States.   AFT Board...

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May3Outset Medical Announces $76.5 Million in Funding for Innovative Dialysis Technology »


-- Financing to Expand U.S. Commercial Introduction and Manufacturing --   SAN JOSE, Calif.--(BUSINESS WIRE)--Outset Medical, a commercial-stage company delivering first-of-its-kind technology into the $13 billion global...

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Mar23Tandem Diabetes Care Announces Pricing of Underwritten Public Offering of Common Stock »


SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced...

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Mar23Valeritas Announces Pricing of $52.5 Million Public Offering of Common Stock »


BRIDGEWATER, N.J., March 23, 2017 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (OTCQB:VLRX) today announced the pricing of its underwritten public offering of 5,250,000 shares of its common stock at a public...

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Mar13Astute Medical Expands Relationship with bioMérieux, Inc. and Ortho Clinical Diagnostics to Enhance Nephrocheck Test Market Access »


San Diego – March 13, 2017 – Astute Medical, Inc. (“Company”), developer of biomarkers for better healthcare, today announced two agreements aimed at expanding global access to the NephroCheck...

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Mar9Autonomic Technologies Announces Expanded Indication in Europe (CE mark) for Disabling Migraine with Pulsante® SPG Microstimulator System »


Cluster headache therapy now indicated for pain relief in highly disabled migraine patients   Redwood City, CA (March 9, 2017) Autonomic Technologies, Inc. announced today that it has received an expanded indication ...

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Mar7Envision Healthcare Enters Definitive Agreement to Acquire Imaging Advantage »


Transaction to Expand Envision’s Radiology Physician Services   Nashville, Tenn. & Greenwood Village, Colo.--(BUSINESS WIRE)--Envision Healthcare Corporation (NYSE: EVHC) has entered into a definitive agreement...

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Mar6TearLab Announces CE Marking for Next-Generation System »


SAN DIEGO, March 06, 2017 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”) today announced that its next-generation in-vitro diagnostics testing platform is in conformity with all...

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Feb27ViewRay Receives FDA 510(k) Clearance for MRIdian Linac »


-- Announces Fourth Quarter and Full Year 2016 Financial Highlights, including Record Revenue and $133.2 million in Backlog --   CLEVELAND, February 27, 2017 — ViewRay, Inc. (Nasdaq: VRAY) announced today that the...

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Feb16National Rheumatology Group AARA Embraces Exagen Diagnostics' Novel Method to Collect and Test for Widely Used Therapies in Lupus and Rheumatoid Arthritis »


Albuquerque, NM and San Diego, CA--(Marketwired - February 16, 2017) - Exagen Diagnostics, Inc. home of AVISE® testing announced today that AARA powered by Bendcare, a national organization of Rheumatologist...

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Feb14AMAG and Endoceutics Enter Into an Exclusive U.S. License Agreement for Intrarosa™ (Prasterone) »


Recently approved first-of-its-kind, non-estrogen prescription therapy for a common symptom of menopause   Conference call scheduled for 8 a.m. ET today   WALTHAM, Mass. and QUEBEC, Feb. 14, 2017 (GLOBE NEWSWIRE) --...

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Feb2Specialists On Call Announces Acquisition of NeuroCall, Reinforces Its Leadership Position in Tele-Neurology Services »


Reston, VA – February 02, 2017 – Specialists On Call, Inc. ("SOC"), a portfolio company of Warburg Pincus LLC and the nation’s leading provider of clinical telemedicine technology and services...

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Feb2Corium Prices Follow-On Offering of Common Stock »


MENLO PARK, Calif., Feb. 02, 2017 (GLOBE NEWSWIRE) -- Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal...

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Jan31Humana Issues Positive Coverage Decision for NanoString's Prosigna® Breast Cancer Assay »


Seattle, Jan. 31, 2017 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that...

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Jan16RainDance Technologies To Be Sold to Bio-Rad »


Billerica, Mass. — January 16, 2017 — RainDance Technologies, a life sciences tools company, announced today that its Board of Directors has entered into a definitive agreement to sell the company...

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Jan6Iroko Pharmaceuticals Announces Key Patent for VIVLODEX® »


Philadelphia, January 6, 2017 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the receipt of a patent for VIVLODEX®(meloxicam) capsules 5...

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Dec14Bio-Techne and Astute Medical Form Strategic Partnership »


Minneapolis, MN and San Diego, CA - Dec. 14, 2016 – Bio-Techne Corporation (NASDAQ: TECH) today closed on a strategic equity investment in Astute Medical, Inc. (San Diego, CA), a diagnostic...

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Dec13Biodesix® Tests Demonstrate Ability to Stratify Patients Treated with Immunotherapy »


VeriStrat® Test Shown To Have Clinical Utility in Predicting Overall Survival of Afatinib-Treated Patients With Lung Cancer   December 13, 2016, Boulder, Colorado… Two studies demonstrating the clinical...

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Dec5Good Start Genetics Announces Marketing Agreement with Roche Diagnostics for Carrier Screening in the United States »


Collaboration Marries Good Start’s Proprietary Technology with Roche Diagnostics’ Commercial Expertise for Broad Market Reach   CAMBRIDGE, Mass., December 5, 2016 /PRNewswire/ – Good Start Genetics, an information solutions...

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Dec4NeuroPace, Inc. Announces Results of 7 Years of Clinical Trial Follow-up Demonstrating 72 Percent Seizure Reduction with the RNS® System »


Study Presented at American Epilepsy Society Meeting Demonstrates Sustained Effectiveness in Adults with Drug-Resistant Partial Onset Epilepsy   Mountain View, Calif. & Houston --(BUSINESS WIRE)-- NeuroPace, Inc. today...

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Nov30Valeritas Elects Joe Mandato, Ph.D., Experienced Medical Device Executive and Investor, to Board of Directors »


BRIDGEWATER, N.J., Nov. 30, 2016 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (OTCQB:VLRX) announced today the election of Joe Mandato, Ph.D., to the Company’s Board of Directors, effective...

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Nov21Omeros Announces Successful Outcome of OMIDRIA® Pediatric Cataract Trial »


Six-Month Extension of Patent Exclusivity and Label Expansion Expected   Seattle --(BUSINESS WIRE)-- Nov. 21, 2016 -- Omeros Corporation (NASDAQ: OMER) today announced the successful outcome of its...

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Nov17FDA Approves Intrarosa for Postmenopausal Women Experiencing Pain During Sex »


The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA),...

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Nov2Good Start Genetics Brings First Next-Generation Sequencing (NGS) Test to Amazon Enabling Broad Access to Carrier Screening for Couples Starting a Family »


Company Establishes Direct Relationship with Largest Online Retailer to Democratize Genetic Testing   Cambridge, MA (November 2, 2016)- Today, Good Start Genetics announced it has launched its VeriYouTM genetic test for...

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Oct14Cardiome Announces Initiation of Commercial Operations in Canada, EH »


Vancouver, Canada, October 14, 2016 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that it has initiated commercial sales operations in Canada. The Canadian sales force will immediately begin detailing AGGRASTAT...

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Oct4GenomeDx and Bostwick Laboratories Announce Marketing Agreement for Decipher Prostate Cancer Classifier Test »


San Diego, CA, Uniondale, NY, October 4, 2016 – GenomeDx Biosciences and Bostwick Laboratories, Inc. today announced that Bostwick has entered into a marketing partnership agreement with GenomeDx, provider of the...

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Sep22Industry Veteran Katherine D. Crothall, PhD to Join Valeritas Board of Directors »


BRIDGEWATER, N.J., Sept. 22, 2016 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (OTCQB:VLRX) announced today the election of Katherine D. Crothall, PhD, to the Company’s Board of Directors, effective...

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Sep19ViewRay Receives CE Mark Approval for its MRIdian Linac System »


-- 510(k) Application Submitted to the FDA --   CLEVELAND, September 19, 2016 — ViewRay, Inc. (Nasdaq: VRAY)announced today that the company has received CE Mark approval for its next generation...

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Sep15Silk Road Medical Announces New Medicare Coverage Option for TransCarotid Artery Revascularization (TCAR) Procedures »


--Medicare to Cover Procedures within the TCAR Surveillance Project Sponsored by the Society for Vascular Surger--   SUNNYVALE, Calif., Sept. 15, 2016 /PRNewswire/ — Silk Road Medical, Inc., a company dedicated to...

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Aug19ViewRay Announces $13.75 Million Private Placement »


--Company preparing for introduction of MRIdian Linear Accelerator Technology--   CLEVELAND, August 19, 2016 — ViewRay, Inc. (Nasdaq: VRAY)announced today that it has entered into a definitive agreement in connection with...

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Aug16Avinger, Inc. Announces Closing of Public Offering of Common Stock and Underwriters’ Full Exercise of Option to Purchase Additional Shares »


Redwood City, Calif., Aug. 16, 2016 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR) (the “Company”), a leading developer of innovative treatments for peripheral artery disease (&ldquo...

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Aug9Cardiome Announces XYDALBA™ Single Dose Infusion Approval by European Medicines Agency »


Vancouver, Canada, August 9, 2016 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that XYDALBA™ (dalbavancin) has been approved by the European Medicines Agency (EMA) for administration as a single, 30...

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Jul26Cardiome Announces Pricing of Public Offering of 10,000,000 Common Shares »


Vancouver, Canada, July 26, 2016 – Cardiome Pharma Corp. (“Cardiome” or the “Company”) (NASDAQ: CRME / TSX: COM) announced today the pricing of its previously announced underwritten public offering ...

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Jul13Valeritas Appoints Brian K. Roberts to its Board of Directors »


BRIDGEWATER, N.J. , July 13, 2016 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (OTCQB:VLRX) announced today the appointment of Brian K. Roberts to the Company’s Board of Directors. Mr. Roberts...

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Jun13Nevro Announces Full Exercise of Over-Allotment Option and Closing of Public Offering of $172.5 Million Convertible Senior Notes »


Redwood City, Calif., June 13, 2016 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic...

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May26Cigna Issues Positive Coverage Decision for NanoString's Prosigna® Breast Cancer Assay »


Seattle, May 26, 2016 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of molecular diagnostic testing products and life science tools for translational research, today announced...

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May19Two-Year Study Results Show the Pulsante® Microstimulator Provides Sustained, Longterm Relief for Cluster Headache Patients »


New hope for cluster headache sufferers   Redwood City, USA, May 19th, 2016 – A peer-reviewed paper* in the International Headache Society journal Cephalagia reported that cluster headache patients treated with...

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May12FDA Clears Next-Generation Version of EndoGastric Solutions’ EsophyX Device »


EsophyX® Z Fastener Delivery System requires fewer steps for Transoral Incisionless Fundoplication (TIF) procedures   REDMOND, Washington—EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for...

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May9Aetna Issues Positive Coverage Decision for NanoString's Prosigna® Breast Cancer Assay »


SEATTLE, May 09, 2016 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of molecular diagnostic testing products and life science tools for translational research, today announced...

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May4TearLab Announces $17.3 Million Registered Public Offering »


SAN DIEGO, May 04, 2016 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (“TearLab” or the “Company”) announced today the pricing of a public offering of...

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May4Valeritas Completes Alternative Public Offering and Raises Gross Proceeds of $25.2 Million »


--Funding Will Support Continued Commercialization of the V-Go® Disposable Insulin Delivery Device and Advance Next Generation Products--   BRIDGEWATER, New Jersey, May 4, 2016 – Valeritas Holdings, Inc. (OTCQB: VLRX) announced...

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Apr25Peter J. Devlin Joins Valeritas Board of Directors as Independent Director »


BRIDGEWATER, New Jersey, April 25, 2016 – Valeritas, Inc. announced today that Peter J. Devlin has been elected to the company's Board of Directors as an independent director. Peter has more...

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Apr25Exagen Points the Way for Patients with Difficult-to-Diagnose Lupus »


San Diego, CA – Exagen Diagnostics, a rheumatology specialty laboratory with offices in Vista, CA, and Albuquerque, NM, is focused on helping patients and their doctors get speedier and more...

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Apr19Rodney D. Altman, MD Joins Valeritas Board of Directors »


-- Valeritas Expands Its Board of Directors --   BRIDGEWATER, New Jersey, April 19, 2016 – Valeritas, Inc. announced today that Rodney D. Altman, MD has been elected to the company's...

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Apr12ViewRay® Appoints Dr. Henry A. McKinnell, Jr. to its Board of Directors »


--Former Pfizer Chairman and CEO Brings Extensive Experience in Life Sciences and Public Companies--   CLEVELAND, April 12, 2016 — ViewRay, Inc. (Nasdaq: VRAY) announced today the appointment of Henry A. McKinnell,...

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Apr4200 Million Americans Now Have Insurance Coverage for Biodesix’ VeriStrat Test »


VeriStrat®, Biodesix’ proteomic blood test for patients with advanced NSCLC, has received multiple positive coverage decisions in 2016. As a result, 200 million Americans now have insurance coverage for VeriStrat....

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Mar8GenomeDx Biosciences Launches Decipher Biopsy Test »


New Predictor of Prostate Cancer Disease Progression Now Available for Newly Diagnosed Patients   San Diego – March 8, 2016 – GenomeDx Biosciences today announced the launch of Decipher Biopsy, a...

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Feb25Valeritas Announces Leadership and Board of Directors Changes »


-- John Timberlake Named as Interim CEO --   BRIDGEWATER, New Jersey, February 25, 2016 – Valeritas, Inc. announced today changes to its executive team this week. John Timberlake has been named...

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Feb4GenomeDx Publishes First Study Supporting Use of Decipher Test in Prostate Biopsy »


-- Company’s Proprietary Genomic Classifier Demonstrates Unprecedented Accuracy in Diagnostic Biopsies Study Published in Urology --   San Diego, Feb 4, 2016 -- GenomeDx Biosciences today announced publication of results...

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Feb1TearLab Announces Proposed Public Offering of Common Stock »


San Diego, Feb. 01, 2016 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ: TEAR) (TSX: TLB) (“TearLab” or “the Company”) announced today its intention to offer, subject to market and...

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Jan7NanoString Technologies Enters Into Collaboration Agreement With Medivation and Astellas to Develop Novel Companion Diagnostic Test »


-- NanoString Eligible to Receive up to $22 Million for Technology Access, Near-Term Milestones and Development Funding --    SAN FRANCISCO, CA and SEATTLE, WA-- (Marketwired - Jan 7, 2016) - Medivation,...

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Jan7GenomeDx’s Decipher® Test Validated to Predict Metastasis from Prostate Cancer Biopsies »


-- Data to Be Presented at 2016 Genitourinary Cancers Symposium --   San Diego, Jan. 7, 2016 -- GenomeDx Biosciences today announced the first validation data supporting use of the Decipher® Prostate...

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Jan6Benvenue Medical Secures $60 Million Financing »


-- Spine Company to Accelerate Commercialization of Luna® 3D Interbody Fusion System and Kiva® VCF Treatment System --   SANTA CLARA, Calif. -- January 6, 2016   Benvenue Medical, Inc.,...

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Dec10CMS Approves Transitional Pass-Through Payment for Outpatient Use of Nevro's Senza® Spinal Cord Stimulation System »


Redwood City, Calif., Dec. 10, 2015 /PRNewswire/ - Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that...

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Dec7RainDance Technologies and Blood Systems Research Institute Collaborate to Develop Ultra-sensitive Assays to Detect and Quantify HIV Latency »


Collaboration provides new amfAR Institute for HIV Cure Research with access to RainDance’s unified Next-Generation Sequencing and Digital PCR platform    Billerica, Mass. — December 7, 2015 — RainDance...

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Dec1Avinger Announces Filing of 510(k) Application for Enhanced Version of Pantheris(TM) »


REDWOOD CITY, Calif., - Dec. 1, 2015 - (GLOBE NEWSWIRE) -- Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and...

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Nov30Nevro Announces the U.S. Patent and Trademark Office's Denial of Boston Scientific Petitions for Inter Partes Review of U.S. Patent No. 8,359,102 »


Redwood City, Calif., Nov. 30, 2015 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that...

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Nov27AFT Pharmaceuticals IPO Confirmed »


AFT Pharmaceuticals IPO Confirmed and Product Disclosure Statement Lodged Demand for AFT shares strong, final share price set at $2.80   Investors will soon be able to buy shares in growing...

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Nov5NanoString Technologies Expands 3D Biology Portfolio With the Commercial Launch of Seven New nCounter PanCancer Profiles to Deeply Probe Cancer Biology »


Focused Gene Expression Panels Are Designed to Combine With Protein Expression Modules and Target Seven Key Aspects of Cancer Biology Including Immuno-Oncology    Seattle, Nov. 5, 2015 (GLOBE NEWSWIRE) -- NanoString...

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Nov2Avinger Successfully Completes VISION IDE Trial for Pantheris(TM) »


-- Final Six-Month VISION Data Presented at VIVA 2015 –   REDWOOD CITY, Calif., Nov. 2, 2015 (GLOBE NEWSWIRE) -- Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for...

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Oct29Smith & Nephew Makes Strategic Investment in Surgical Robotics with Acquisition of Blue Belt »


Smith & Nephew (LSE:SN, NYSE:SNN), the global medical technology business, announces it has agreed to acquire Blue Belt Holdings, Inc. (“Blue Belt Technologies”) for $275 million, securing...

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Oct26Endologix, Inc. and TriVascular Technologies, Inc. Announce Merger to Create a Leading Cardiovascular Growth Company Focused on the Treatment of Aortic Disorders »


Combined Product Portfolio to Provide Clinicians With a Broad Range of Endovascular AAA Devices   Will Expand U.S. and European Sales Organizations to Enhance Growth and Provide Excellent Clinical...

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Oct18ViewRay® Receives Regulatory Approval to Sell MRI-Guided Radiation Therapy System in Korea »


First Patient Outside of the United States Treated at Seoul National University Hospital    Cleveland, October 18, 2015 — ViewRay, Inc. (OTCQB:VRAY) announced today that the company has received regulatory...

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Oct14Good Start Genetics Establishes National Relationship with UnitedHealthcare »


CAMBRIDGE, Mass., October 14, 2015 – Good Start Genetics®, Inc., a commercial-stage molecular genetics information company, announced today that it has established a new national relationship with UnitedHealthcare to...

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Oct14Avinger, Inc. Receives FDA 510(k) Clearance for Pantheris(TM) »


-- Image-Guided Atherectomy Device Cleared to Treat Patients Suffering From PAD --   REDWOOD CITY, Calif., Oct. 14, 2015 (GLOBE NEWSWIRE) -- Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided,...

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Oct12Astute Medical Announces Signing of Distribution Agreement with Fosunpharma for Nephrocheck® Test in China with $20 Million Financing »


Deal Expands Global Access to First-Of-Its-Kind FDA-Cleared Test for Acute Kidney Injury Risk   San Diego – October 12, 2015 -- Astute Medical, Inc., today announced the signing of an agreement...

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Oct9Medical Necessity of Tear Osmolarity Testing in the Diagnosis and Management of Dry Eye Disease Confirmed in Recently Published Medicare Local Coverage Determination »


San Diego, Oct. 9, 2015 (GLOBE NEWSWIRE) -- TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") announced today that First Coast Service Options, Inc. (the Medicare Area Contractor for Florida,...

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Sep29Good Start Genetics Announces EmbryVu »


-- Good Start Genetics Launches EmbryVu™, Affordable PGS Testing --   Cambridge, MA (September 29, 2015) – Good Start Genetics, Inc., a commercial-stage molecular genetics information company, announced today the availability...

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Sep22Ceterix Announces FDA Clearance & U.S. Commercial Availability of Next-Gen Meniscus Repair Device »


-- NovoStitch Plus Enables Meniscus Preservation for More Patients --   MENLO PARK, Calif. – Sept. 22, 2015 – Ceterix® Orthopaedics, Inc., a developer of novel surgical tools that improve a...

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Sep17NICE Evaluation and Tariff Code Announcements to Increase UroLift® System Availability in UK NHS Patients with Enlarged Prostate »


Pleasanton, CA, US – NeoTract, Inc., today welcomed the announcement by NICE that its UroLift® System (Prostatic Urethral Lift) to treat an enlarged prostate (benign prostatic hyperplasia) saves the...

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Sep10NanoString Technologies Expands Immuno-Oncology Portfolio With Commercial Launch of Innovative nCounter RNA:Protein PanCancer Immune Profiling Panel »


-- Breakthrough RNA:Protein Technology Enables Sensitive, Simultaneous Measurement of Gene and Protein Expression, Driving a New Paradigm in Tumor Profiling --    SEATTLE, Sept. 10, 2015 (GLOBE NEWSWIRE) -- NanoString...

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Sep9ESMO Clinical Practice Guidelines for Breast Cancer Recommend the Use of Prosigna/PAM50 Assay for Determining Potential Benefit From Chemotherapy »


SEATTLE, Sept. 9, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that the PAM50 gene signature,...

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Sep9Tandem Diabetes Care Announces FDA Approval of t:slim G4 Insulin Pump with CGM Integration »


The First and Only CGM-enabled Touch-Screen Pump    San Diego, Sept. 9, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced U.S. Food and Drug Administration approval...

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Sep8 Blue Belt Technologies Announces Support for Smith & Nephew’s ZUK knee on the Navio Surgical System »


Minneapolis, MN. (September 8th, 2015) - Blue Belt Technologies, a medical device company specializing in advanced technology solutions for orthopedic surgery, announces commercial support for Smith & Nephew’s ZUK...

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Aug19ViewRay® Completes Private Placement, Raises Aggregate of $29.4 Million »


Total Financing in Last Two Months Reaches Up To Almost $80 Million    Cleveland, Aug. 19, 2015 /PRNewswire/ -- ViewRay, Inc. (OTCQB: VRAY) announced today the completion of its private placement offering...

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Aug13NanoString Technologies Receives Favorable Final Local Coverage Determination by Palmetto GBA for Its Prosigna Breast Cancer Assay »


Seattle, Aug. 13, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Palmetto GBA, a Medicare...

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Aug5Corium Prices Follow-On Offering of Common Stock »


MENLO PARK, Calif., Aug. 5, 2015 (GLOBE NEWSWIRE) -- Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the...

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Aug4TriVascular Technologies, Inc. Receives FDA Approval of the Ovation iX(TM) Abdominal Stent Graft System »


Next Generation Aortic Body Delivery System Approval Continues Strong Cadence of New Product Introductions    Santa Rosa, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV) announced today...

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Jul30Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems »


San Diego, July 30, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps, today...

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Jul23ViewRay Completes Alternative Public Offering, Raises $26.7 Million »


Funding to Support Further Innovation and Commercialization of MRI-Guided Radiation Therapy System    Cleveland — July 23, 2015 — ViewRay, Inc. (OTCQB: VRAY) announced today its successful completion of a reverse...

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Jul16NCCN Clinical Practice Guidelines for Breast Cancer Acknowledge Prosigna/PAM50 as Clinically Validated for Prediction of Prognosis »


SEATTLE, July 16, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that the National Comprehensive Cancer...

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Jul15NanoString Technologies Launches New nCounter SPRINT(TM) Profiler Designed to Meet Needs of the Individual Researcher »


Expanded nCounter® Instrument Product Line Expected to Reach Deeper Into Cancer Research Market     Seattle, July 15, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life...

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Jun15TriVascular Technologies, Inc. Announces FDA Approval of Ovation iX(TM) Iliac Stent Graft »


Enhancements to Iliac Stent Graft Technology Are Designed to Improve Ease of Use and Expand Patient Applicability    Santa Rosa, Calif., June 15, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq...

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Jun2Nevro Announces Pricing of Upsized Public Offering of Common Stock »


Public Offering of 4,705,880 Shares of Common Stock at $51.00 per Share, Resulting in Aggregate Proceeds of Approximately $240.0 Million    Menlo Park, Calif., June 2, 2015 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a...

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May29In New Cardiac Surgery Study Nephrocheck® Kidney Biomarkers Rise To The Occasion »


-- JAMA-Published Study Shows Significant Reduction in Acute Kidney Injury; Supports Utility of TIMP-2 AND IGFBP-7 --   SAN DIEGO – May 29, 2015     An intervention known as remote...

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May28Merck and NanoString Announce Clinical Research Collaboration to Develop an Immune-Related Gene Expression Assay for Use in the Development Program for KEYTRUDA® (pembrolizumab) »


Collaboration Builds on Merck's R&D and NanoString's Biomarker Development Leadership Positions in Immuno-Oncology   Early Data Evaluating Immune-Related Signatures with KEYTRUDA in Multiple Cancers to be...

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May19Tandem Diabetes Care Launches t:flex™ Insulin Pump »


Largest Capacity Insulin Pump Available in U.S. - For People with Greater Insulin Needs   San Diego, May 19, 2015 /PRNewswire/-- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical...

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May12St. Gallen International Breast Cancer Guidelines Recognize Power of Prosigna/PAM50 to Inform Treatment Decisions and Spare Low Risk Breast Cancer Patients Unnecessary Chemotherapy »


Prosigna Only Test Identified as Clearly Prognostic Both During First Five Years and Beyond Five Years Following Diagnosis     Seattle, May 12, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc., (Nasdaq:NSTG)...

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May8Nevro Receives FDA Approval for Senza® Spinal Cord Stimulation System Delivering HF10 Therapy »


Menlo Park, Calif., May 8, 2015 — Nevro Corp. (NYSE: NVRO), a medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has...

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May5Pacific Biosciences and RainDance Technologies Partner to Co-Develop and Commercialize Novel Solution For de novo Whole Genome Assembly »


Partnership combines Pacific Biosciences’ Single Molecule, Real-Time (SMRT®) Sequencing and informatics capabilities with RainDance’s proprietary digital droplet and single molecule barcoding technology    Menlo Park,...

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Apr30NeoTract Announces Positive Guidelines from European Association of Urology for Minimally Invasive Treatment for Benign Prostatic Hyperplasia »


UroLift System Recognized for High Level of Clinical Evidence    Pleasanton, Calif. – April 30, 2015– NeoTract, Inc., a medical device company focused on addressing unmet needs in the field...

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Apr28Aequus and Corium Enter Into Product Development Collaboration Focused on CNS »


MENLO PARK, Calif. and VANCOUVER, British Columbia, April 28, 2015 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc., (Aequus) (TSX-V:AQS), a specialty life sciences company focused on providing patients with differentiated and enhanced...

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Apr21Biodesix Receives Carefirst Bluecross Blueshield (bcbs) Coverage for Veristrat Test »


-- Diagnostic deemed medically necessary to guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC) --   Biodesix , Inc. today announced that its VeriStrat® test received...

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Apr20RainDance Launches ThunderBolts Next-Gen Sequencing Panel to Research Genetic Mutations for Myeloid Malignancies »


Hematologic oncology research experts to present ThunderBolts Myeloid Panel performance data at American Association for Cancer Research (AACR) Annual Meeting    Billerica, Mass. — April 20, 2015 — RainDance Technologies, Inc.,...

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Apr16RainDance Technologies Extends Global Commercial Reach with Distributor Appointments in Europe and Middle East »


BioTech-Europe, Diatech, Labgene Scientific, and Neo-Science embrace company’s award-winning droplet technology platform to meet growing demand for liquid biopsy research applications    Billerica, Mass. — April 16, 2015 —...

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Apr16NanoString Technologies Empowers Cancer Researchers With Three Innovative New Products for the nCounter Analysis System »


Introduction of RNA: Protein Profiling Panel Focused on Immuno-Oncology Addresses the Next Generation of Tumor Profiling   Launch of Two New PanCancer Gene Expression Panels Strengthens Portfolio of Tools to...

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Apr13Good Start Genetics Enters Exclusive License Agreement with Johns Hopkins University for Noninvasive Prenatal Testing (NIPT) »


Proprietary Technology to Enable Simpler Workflows and Decreased Costs for the Detection of Fetal Chromosomal Abnormalities from a Maternal Blood Sample    CAMBRIDGE, Mass., April 13, 2015 - Good Start Genetics...

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Mar18NanoString Technologies' Prosigna Breast Cancer Assay Included in German Breast Cancer Treatment Guidelines »


Eligibility for German Government Reimbursement to Begin for Qualifying Patients    Seattle, March 18, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational...

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Mar17Astute Medical, Inc. Lauds Launch of Global Initiative To End Acute Kidney Injury »


-- Company Joins in Call to Eliminate Preventable Deaths by 2025 --   SAN DIEGO – March 17, 2015 – Astute Medical, Inc. today hailed the launch of a collaborative global initiative calling...

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Mar4Tandem Diabetes Care Announces Closing of Underwritten Public Offering of Common Stock »


SAN DIEGO, March 4, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps,...

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Feb25RainDance Expands ThunderBolts Portfolio with Launch of Low-Cost, Low-Input Next-Gen Sequencing Enrichment System for Liquid Biopsy »


ThunderBolts™ System ensures accurate and precise detection of somatic mutations as low as 1% in circulating cell-free DNA   Billerica, Mass. — February 25, 2015 — RainDance Technologies, Inc., a...

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Feb9NeoTract Receives Reimbursement Coverage from Noridian Healthcare Solutions for Minimally Invasive Treatment for Enlarged Prostate »


UroLift System Treatment Now Covered for 6.6 Million Medicare Beneficiaries in Thirteen States    Pleasanton, Calif. – February 9, 2015 – NeoTract, Inc., a medical device company focused on addressing unmet needs...

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Feb4Nevro Receives Expanded MR-Conditional Labeling for Senza® Spinal Cord Stimulation System in Europe and Australia »


Senza is the first implantable spinal cord stimulator system that is 3 Tesla MRI compatible    Menlo Park, Calif., Feb. 4, 2015 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a medical device company...

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Jan22bioMérieux and Astute Medical sign a global agreement to develop and market NEPHROCHECK® Test »


Marcy l’Etoile, (France) and San Diego, California (United States), January 22, 2015 - bioMérieux, a world leader in the field of in vitro diagnostics,...

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Jan22Nevro Receives Approvable Letter from U.S. Food and Drug Administration for Senza® SCS »


MENLO PARK, Calif., Jan. 22, 2015 — Nevro Corp. (NYSE: NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today...

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Jan12Tandem Diabetes Care Announces FDA Clearance of the t:flex™ Insulin Pump »


SAN DIEGO, Jan. 12, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® Insulin Pump, today announced that the...

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Dec17Ortho-Clinical Diagnostics, Inc. Introduces the Astute NEPHROCHECK® Test System »


-Early knowledge of AKI risk may prompt closer patient monitoring and help prevent permanent kidney damage or death-   RARITAN, NJ – December 17, 2014 – Ortho-Clinical Diagnostics, Inc. today...

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Dec10Good Start Genetics, IviGen and Igenomix Announce Exclusive Relationship in Reproductive Testing »


Partner on Expansive Suite of Advanced, Genetics-based Products to Manage Infertility    CAMBRIDGE, Mass. and VALENCIA, Spain, December 10, 2014 -- Good Start Genetics®, Inc., a commercial-stage molecular genetic information...

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Dec8NanoString Technologies Updates Prosigna FDA Labeling to Provide Greater Insight into Probability of Breast Cancer Recurrence Between Year 5 and 10 After Diagnosis »


The Prosigna Score Provides Important Information for Node-Negative and Node-Positive (1-3 Nodes) Breast Cancer Patients in the First 5 Years and 5 to 10 Years After Diagnosis    Seattle --(BUSINESS WIRE...

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Nov10NeoTract, Inc. Announces CMS Reimbursement for Innovative Minimally Invasive Procedure for Enlarged Prostate »


Category I CPT Codes Will Expand Patient Access to Novel Treatment for Common Condition that Significantly Impacts Quality of Life   Pleasanton, Calif. – November 10, 2014 – NeoTract, Inc., a medical...

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Nov6Nevro Corp. Announces Pricing of Initial Public Offering »


Menlo Park, Calif., Nov. 6, 2014 — Nevro Corp. (NYSE:NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today...

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Oct27Biodesix Announces Inclusion of VeriStrat in Updated NCCN Guidelines »


Guidelines provide evidence-based, consensus-driven recommendations for managing cancer   Biodesix Inc., a molecular diagnostics company dedicated to advancing precision medicine and improved patient care, today announced that its ...

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Oct15TriVascular Announces FDA Approval of CustomSeal(TM) Technology for the Ovation Prime(R) System »


Customized Sealing Technology Enables Faster Procedure Times, Preserves the Aortic Neck and Provides an Optimized Seal Tailored to Each Patient's Specific Anatomy    Santa Rosa, Calif., Oct. 15, 2014 (GLOBE...

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Sep9Biodesix Receives Highmark Blue Cross Blue Shield Coverage for VeriStrat Test »


-- Lung cancer diagnostic deemed medically necessary to guide treatment decisions –   Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced that its VeriStrat...

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Jun9Exagen Diagnostics Launches Prognostic Panel »


Albuquerque, N.M., June 9, 2014 – Exagen Diagnostics Inc., a leading medical diagnostic company focused in rheumatology, today announced the addition of the Avise SLE Prognostic panel to its testing services. ...

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May6NanoString Technologies Receives Canadian Market Approval for its Prosigna Breast Cancer Prognostic Gene Signature Assay »


The Prosigna Assay on the nCounter Dx Analysis System Provides Compelling Clinical Data, Clear Patient Report, and Localized Processing in Qualified Canadian Labs    Seattle --(BUSINESS WIRE)--...

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Apr29TriVascular Announces FDA-Approved Expansion of Ovation® and Ovation Prime™ Indication Statements »


More Patients Now Have Access to a Less Invasive, On-Label, Clinically Proven Endovascular Aortic Repair (EVAR) Solution   Santa Rosa, Calif., April 29, 2014 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq:TRIV),...

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Apr22TriVascular Technologies, Inc. Announces the Closing of Its Initial Public Offering »


Santa Rosa, Calif., April 22, 2014 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq:TRIV), manufacturer of the Ovation Prime™ Abdominal Stent Graft System, today announced the closing of its initial public...

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Apr10AVEO and Biodesix Partner to Co-Develop and Commercialize Ficlatuzumab with a Companion Diagnostic for Treatment of NSCLC »


Biodesix to Fund Proof of Concept Study    AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. today announced that they have entered into a worldwide agreement to develop and commercialize...

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Mar17Good Start Genetics Announces Collaboration with PerkinElmer to Bring GoodStart Select ™ Carrier Screening Tests to Broader Women’s Health Market »


Agreement Will Greatly Expand Access to Reproductive Health Community    CAMBRIDGE, Mass., March 17, 2014 - Good Start Genetics®, Inc., an innovative molecular genetic information company, today announced a strategic...

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Mar3RainDance Technologies Closes Series E Financing with GE »


GE Ventures support RainDance’s vision to make liquid biopsy a commercial reality   Billerica, Mass. – March 3, 2014 – RainDance Technologies, Inc., an innovative genomics tools company making molecular...

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Mar3Biodesix Receives CE Mark for VeriStrat Specimen Collection and Shipping Kit »


-- Blood-based protein diagnostic predicts differential treatment outcomes for non-small cell lung cancer --   Mar 3, 2014 - Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today...

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Jan13Good Start Genetics Announces Contract with Tufts Health Plan to Cover GoodStart Select ™ Carrier Screening Test »


CAMBRIDGE, Mass., January 13, 2014 -- Good Start Genetics®, Inc., an innovative molecular diagnostics company harnessing a powerful, proprietary next-generation DNA sequencing (NGS) capability, today announced that the company has signed...

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Nov18TriVascular Secures $40 Million in Equity Financing »


November 18, 2013—TriVascular, Inc. (Santa Rosa, CA) announced the close of a $40 million Series E Preferred Stock equity financing that the company will use to support worldwide commercialization, product development,...

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Nov13RainDance RainDrop System Proven to be Industry’s Most Precise Digital PCR Platform for Measuring Chromosomal Copy Number »


Company presents results demonstrating accurate detection of small chromosomal differences at CNAPS VIII Conference and showcases technology at AMP 2013 Annual Meeting   Billerica, Mass. – Nov. 13, 2013...

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Jan21TriVascular Receives U.S. FDA Approval for the Ovation Prime™ Abdominal Stent Graft System »


Innovative Delivery System Further Enhances Ease of Use   Santa Rosa, CA, January 21, 2013 – TriVascular, Inc. today announced U.S. Food & Drug Administration (FDA) approval of the Ovation...

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