NuVasive’s Q4 profits surge, swings to black for 2015
NuVasive Inc. (NSDQ:NUVA) yesterday reported 4th-quarter and full-year results that topped expectations on Wall Street, posting a Q4 profit increase of nearly 54% and swinging to black ink for 2015....
View ArticleJury docks Johnson & Johnson $14m in pelvic mesh lawsuit
A jury in Philadelphia this week reportedly docked Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon $13.5 million in the 2nd case involving its pelvic mesh products to go to trial in a mass tort in...
View ArticleZimmer Biomet wins 510(k) for Unite3D
Zimmer Biomet (NYSE:ZBH) said yesterday it won FDA 510(k) clearance for its Unite3D bridge fixation system designed for foot and ankle joint fusion surgery, as an alternative to traditional plates,...
View ArticleUK’s NICE backs Medtronic’s MiniMed Paradigm Veo
Medtronic (NYSE:MDT) said today the U.K.’s National Institute for Health and Care Excellence issued positive guidance recommending the MiniMed Paradigm Veo insulin pump and integrated glucose sensor...
View ArticleTitan Medical closes $7.6m offering
Titan Medical (CVE:TMD) said today it closed its most recent offering, raising $7.6 million (CAD $10.5 million) by floating 11.7 million shares at 65¢ (CAD 90¢) per share to support its Sport robotic...
View ArticleBard touts data from Lutonix head-to-head study against MDT’s In.Pact
C.R. Bard (NYSE:BCR) subsidiary Bard Peripheral Vascular touted results showing no significant difference in a study pitting its Lutonix DCB against Medtronic‘s (NYSE:MDT) In.Pact DCB in treating...
View ArticleMassDevice.com +3 | The top 3 medtech stories for February 12, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
View ArticleU.S., EU medical device associations push ‘regulatory cooperation’
Medtech industry advocacy groups on both sides of the Atlantic are pushing for regulatory cooperation in the Transatlantic Trade and Investment partnership, which is entering its 3rd year of...
View ArticleValtech touts German reimbursement win for Cardioband
Valtech Cardio said Tuesday it won reimbursement in Germany for its Cardioband Mitral Reconstruction System designed to treat mitral regurgitation in heart failure patients. The Cardioband system is...
View ArticleRTI Surgical inks deal with Oxford Performance Materials
RTI Surgical said yesterday it inked a deal with Oxford Performance Materials to license its OsteoFab platform for spinal applications. OPM’s OsteoFab is a next-generation implant manufacturing process...
View ArticleGN Store Nord’s shares jump as profits rise in fourth quarter
(Reuters) – Shares in Denmark’s GN Store Nord jumped as much as 15% on Friday after its financial results met forecasts following previous misses, legal problems and fears over the performance of one...
View ArticleAustralia’s Cochlear wants to buy govt hearing service, raises profit outlook...
(Reuters) – The Australian government said it is weighing a proposal from a consortium including hearing implant maker Cochlear Ltd. (ASX:COH) to buy a state-owned hearing service, a move likely to...
View ArticleClarifying what we mean when we talk about biomarkers: An NIH/FDA joint...
By: Melissa A. Robb, B.S.N., M.S. (RegSci), and Robert M. Califf, M.D. What if there was a more uniform way to convey key technical terms to help advance scientific progress? Thanks to the Biomarkers,...
View ArticleInnovative laboratory technology highlights Mack Molding’s capabilities
Mack Molding has announced it is working with an Oxford, U.K.- and Boston, Mass.- based laboratory equipment developer that is redefining how research laboratories operate. LabMinds’ lead product,...
View ArticleStryker to pay $1.3B for Physio-Control
Stryker (NYSE:SYK) said today that it agreed to pay $1.28 billion to Bain Capital for automated external defibrillator maker Physio-Control. Medtronic (NYSE:MDT) sold Physio-Control to Bain for $478...
View ArticleStryker’s Howmedica slips CerviCore lawsuit
A California federal judge dismissed a suit against Stryker (NYSE:SYK) subsidiary Howmedica Osteonics Corp that claimed the company failed to warn the plaintiff that its CerviCore spinal implant could...
View ArticleDirect Flow debuts transcatheter mitral valve
Direct Flow Medical said yesterday it premiered its transcatheter mitral valve, developed as part of its TMV development program. The debut was made at the 2nd annual Zurich Heart Team Mitral Valve...
View ArticleFDA approves trial for J&J’s Mentor MemoryGel breast implant
Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it won FDA investigational device exemption approval for its Athena clinical trial testing its Mentor MemoryGel breast implants....
View ArticleFDA clears Chemence’s Exofin tissue adhesive
Chemence Medical said yesterday it won FDA 510(k) for its Exofin topical skin adhesive designed for wound closure. The Alpharetta, Ga.-based company said it will offer the Exofin sealant in 2 sizes,...
View ArticleUnilife, Amgen extend negotiations a 3rd time
Unilife (NSDQ:UNIS) and Amgen (NSDQ:AMGN) are tacking on another 11 days to come to an agreement on whether their deal for Unilife’s wearable injector technology will be exclusive to Amgen or not. The...
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