E-Qure wins FDA nod to expand chronic wound treatment device trial
Chronic wound treatment device developer E-Qure said today it won FDA approval to expand and launch a pivotal trial of its Bio-electrical Signal Therapy Device chronic wound treatment device. The New...
View ArticleTissue Regenix expands, launches DermaPure in US
Tissue Regenix said today it expanded its operations to the US, now offering its DermaPure product for chronic and acute wound care indications in the region. The U.K.-based company’s dCell...
View ArticleRussian deadline for replacing old medical device license extended
By Stewart Eisenhart, Emergo Group The Russian government has pushed back a deadline for replacing medical device registration licenses issued before 2013 to December 2021 in order to harmonize...
View ArticleIntersect ENT wins FDA nod for Propel Contour steroid-releasing implant
Intersect ENT(NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo...
View ArticleMedtronic lands CE Mark for quad MRI-safe pacers
Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its line of quadripolar, MRI-safe cardiac resynchronization therapy pacemakers. The approval covers Medtronic’s...
View ArticleMedtronic touts Solitaire stent retriever data
Medtronic (NYSE:MDT) yesterday touted data presented at the International Stroke Conference on its Solitaire stent retriever from 4 studies. The Solitaire stent retriever uses a micro-sized catheter to...
View ArticleInspireMD logs provisional win in $3m funding fee bid
InspireMD (NYSE:NSPR) logged a provisional win yesterday in a battle over nearly $3 million it allegedly owes in finder’s fees related to some $24 million in financing for the cardiac device maker....
View ArticleCEOs shouldn’t fear Trump: Ex-Medtronic chief George
Although the administration’s promises for lower taxes, fewer regulations and improved infrastructure would be a boon to business, CEOs are leery of other pledges to impose large tariffs for imported...
View ArticleBio-Rad to pony up $3.5m for ex-GC’s legal fees; misses on Q4 earnings
Bio-Rad Laboratories (NYSE:BIO) agreed to pay $3.5 million in legal fees for the team that represented former general counsel, Sanford Wadler, during a whistleblower retaliation lawsuit Wadler brought...
View ArticleIntegra LifeSciences closes $200m Derma Sciences buy
Integra LifeSciences (NSDQ:IART) said today that it closed its $205 million buy of Derma Sciences (NSDQ:DSCI) and its line of wound care products. The $7-per-share deal included a line of regenerative...
View ArticleFDA panel supports Claret Medical’s Sentinel, despite efficacy questions
The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection device despite weak efficacy data for the device. The Santa...
View ArticleBaxter reveals DoJ probe of Tisseel, Artiss sealants
Baxter (NYSE:BAX) this week said it received a civil investigative demand from the US Dept. of Justice’s Commercial Litigation Branch related to its Tisseel and Artiss products. The Deerfield,...
View ArticleXenex zaps a $38m funding round for LightStrike robots
Xenex Disinfection Services said today that it raised a $38 million funding round, led by private equity shop Essex Woodlands, for its LightStrike “germ-zapping robots.” New backer Piper Jaffray...
View ArticleLima, IPG ink value-based ortho offering partnership deal
Lima Corporate and device benefit management solutions provider IPG said today they inked a partnership deal to support value-based care delivery of Lima’s orthopedic products in the US. Atlanta,...
View ArticleMassDevice.com +5 | The top 5 medtech stories for February 24, 2017
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 Article7 disruptive innovations from medical device suppliers
Sometimes an innovation out of a contract manufacturer is truly disruptive when it comes to its potential for the medical device industry. Chris Newmarker, Managing Editor [Image from Unsplash.]People...
View ArticleStudy: Abbott’s CardioMEMS monitor performs better in real world than pivotal...
Real-world results from patients with Abbott‘s (NYSE:ABT) CardioMEMS implantable heart monitor, which it acquired along with St Jude Medical in Jan., show greater reduction in pulmonary artery pressure...
View ArticleStudy: Shifting to radial access PCIs could save hospitals $332m a year
A new study has shown that shifting 30% of femoral-access PCI procedures to transradial-access with same-day discharge for stable patients could save U.S. hospitals $332 million annually....
View ArticleAugmenix touts more SpaceOar data
Augmenix touted data today from a Phase III trial evaluating its SpaceOar hydrogel in men undergoing prostate radiotherapy. The study showed that the company’s device, placed between the prostate and...
View ArticleTarget is supporting health and wellness startups: Here’s how
U.S. retail giant Target is taking the initiative to support health startups around the world, with a goal of boosting its wellness product offerings. Target is launching a new program called “Target...
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