PwC California Life Sciences report highlights continued investment, growth
The California Life Sciences Assn. and PricewaterhouseCoopers released their annual Life Sciences Industry Report, highlighting continued growth and a robust pipeline of medical devices and other...
View ArticleFDA expands indication for Medtronic’s Solitaire stent retriever
Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for an expanded indication for its Solitaire stent retriever. The new indication covers its use as an initial treatment for acute...
View ArticleEndologix shares dive on FDA request for more Nellix data
Endologix (NSDQ:ELGX) shares are off nearly -25% today after the company said the FDA asked for more data on its Nellix stent graft for treating abdominal aortic aneurysms. Irvine, Calif.-based...
View ArticleBristol-Myers Squibb, Enterome ink immuno-oncology collab
Bristol-Myers Squibb (NYSE:BMY) said today that it inked a collaboration agreement with Enterome to discover and develop microbiome-derived biomarkers and drug targets as potential companion...
View ArticleCellnovo files 510(k) for connected diabetes management system
Cellnovo (EPA:CLNV) said today that it has filed for 510(k) clearance from the FDA for its diabetes management system. Paris-based Cellnovo touts its system as the 1st mobile, connected diabetes...
View ArticleActamax touts clinical data for sprayable adhesion barrier device
Actamax Surgical Materials, a DSM-DuPont joint venture, touted data from a 12-month clinical follow-up study evaluating the effects of its biocompatible, resorbable adhesion barrier device. The results...
View ArticleCumberland Pharma acquires U.S. rights to Nordic’s injectable methotrexate
Cumberland Pharmaceuticals (NSDQ:CPIX) said today that it acquired exclusive U.S. rights to Nordic Group‘s injectable methotrexate product line to treat rheumatoid arthritis, juvenile idiopathic...
View ArticleOlympus wins FDA nod & launches new power morcellator with tissue capture
Olympus (TYO:7733) said today it won FDA 510(k) clearance for its next-gen laparoscopic PK morcellator with tissue containment designed as a laparoscopic surgery option to avoid open hysterectomy and...
View ArticleSmithsonian collects early robot-assisted surgery device
Medical device and robotic surgery history is heading to the Smithsonian’s Natural Museum of American History, in the form of a 1989 prototype of Robodoc, an early orthopedic surgical robot. The...
View ArticleSt. Jude Medical’s HeartMate 3 implantable pump beats HeartMate II in pivotal...
The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in...
View ArticleSkin treatment device developer Clarify Medical raises $4m
Skin lesion treatment device developer Clarify Medical said today it raised $3.6 million through a private financing round with existing an new investors. Funds from the round will support the...
View ArticleMassDevice.com +5 | The top 5 medtech stories for November 16, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
View ArticleFDA posts 2 new Class I HeartWare HVAD recalls
The FDA today released information on 2 new Class I recalls for Medtronic‘s (NYSE:MDT) HeartWare Ventricular Assist Devices, affecting a total of 4,669 units. A Class 1 indication from the federal...
View ArticleBoston Scientific touts HeartLogic study data
Boston Scientific (NYSE:BSX) today released the results from the 1st clinical trial of its HeartLogic heart failure diagnostic service, touting a high level of sensitivity and low unnecessary alert...
View ArticleAstute Medical raises $2 million
Astute Medical raised $2 million in a new round of debt financing, according to an SEC filing posted today. San Diego-based Astute Medical develops and produces the NephroCheck, a device designed to...
View ArticleApama Medical raises $13m
Novel catheter ablation tech developer Apama Medical raised $13.2 million in a new round of equity financing, according to an SEC filing posted today. Apama Medical is developing novel ablation...
View ArticleNanoparticle “barcodes” help track cancer drug efficacy
Researchers from Technion Institute of Technology in Israel reported on a method of tagging cancer drugs with “barcodes” to monitor tumor growth. The team detailed their methods in a study published in...
View ArticleAppeals court upholds $15m Medtronic loss to bone cement acquisition Pabban...
Medtronic (NYSE:MDT) is still on the hook to pay $15.4 million to bone cement maker Pabban Development for breaking the terms their 2008 acquisition deal, a federal appeals court ruled yesterday....
View ArticleSubject participation in clinical trials is paramount
Obtaining useful and meaningful data is one of the goals of any clinical trial. However, in order to attain the necessary data, subject participation in clinical trials is paramount as subjects are the...
View ArticleAlere agrees to cough up probe docs to Abbott
Alere (NYSE:ALR) shares rose yesterday after it agreed to give documents to Abbott (NYSE:ABT), which is hoping to rescind its $6 billion offer to acquire the diagnostics company, covering probes into...
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