Masimo wins $36m Defense Dept. contract
Masimo (NSDQ:MASI) won a contract from the U.S. Defense Dept. worth nearly $36 million for its pulse oximeters. The 5-year deal calls for Irvine, Calif.-based Masimo to provide the devices to the U.S....
View ArticleWhat we mean when we talk about EvGen part II: Building out a national system...
By: Rachel E. Sherman, M.D., M.P.H., and Robert M. Califf, M.D. In an earlier FDA Voice blog post, we discussed a pair of concepts – interoperability and connectivity – that are essential prerequisites...
View ArticleAppeals court denies Biolitec in Angiodynamics spat
The 1st Circuit Court last week denied German medical laser maker Biolitec‘s (ETR:BIB) challenge to a Massachusetts federal court ruling which found for AngioDynamics (NSDQ:ANGO) and set possible...
View ArticleAbbott’s Tecnis Symfony intraocular lens clears pivotal trial
Abbott (NYSE:ABT) said today its Tecnis Symfony 1-piece acrylic intraocular lens met its primary endpoint in the pivotal trial of the device designed for cataract surgery. Data from the trial indicated...
View ArticlePhilips optimistic about Cleveland plant despite Q1 losses
Royal Philips (NYSE:PHG) said it is optimistic it will see its Cleveland plant turn a profit this year, despite seeing losses increase during the 1st quarter. The company saw losses grow at the plant...
View ArticleMassDevice.com +5 | The top 5 medtech stories for May 9, 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 ArticleGI Dynamics touts new safety, efficacy data for EndoBarrier
GI Dynamics (ASX:GID) today touted new safety and efficacy data on its EndoBarrier device designed for weight loss, claiming meaningful improvements in hemoglobin A1c levels and weight reduction in...
View ArticleReWalk Robotics touts reimbursement win for powered exoskeleton
ReWalk Robotics (NSDQ:RWLK) said today it won reimbursement coverage through a commercial health insurance plan which made changes to include powered exoskeletons for ambulation in patients with lower...
View ArticleNeoTract touts 4-year UroLift data
NeoTract today released the results from 2 randomized studies of its UroLift system designed to treat benign prostatic hyperplasia, touting “excellent” durability after 4 years. The data was presented...
View ArticleHealth Canada extends compliance deadline for commercially reprocessed...
By Stewart Eisenhart, Emergo Group Health Canada, the Canadian medical device market regulator, plans to extend its deadline for commercially reprocessed devices to obtain Medical Device and Medical...
View ArticleSterigenics International increases European ethlyene oxide capacity with...
Sterigenics International LLC, a provider of contract sterilization, gamma technologies and medical isotopes, and a portfolio company of Warburg Pincus and GTCR, announced expansion at their Wiesbaden,...
View ArticleJohnson & Johnson’s DePuy picks up BioMedical Enterprises
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics said yesterday that it acquired BioMedical Enterprises, which makes implants for small bone fixation, for an undisclosed amount. San...
View ArticleLayoffs ahead as Haemonetics restructures, names new CEO
Haemonetics (NYSE:HAE) said yesterday that it plans to take a pre-tax charge of $26 million, including $17 million worth of “termination benefits,” as part of another round of layoffs aimed at boosting...
View ArticleNinePoint Medical wins FDA nod for real-time targeting on NvisionVLE device
NinePoint Medical said today that it won 510(k) clearance from the FDA for a real-time targeting feature on its flagship NvisionVLE gastrointestinal imaging device. NvisionVLE uses optical coherence...
View ArticleSenate panel once again slams physician-owned distributorships
The U.S. Senate’s Finance Committee today issued a report slamming physician-owned distributorships that sell the spinal implants their doctor-owners prescribe. It’s not the 1st time that so-called...
View ArticleBaxter issues 4-year forecast
Baxter (NYSE:BAX) yesterday said it hopes to grow earnings per share to $3 over the next 4 years, as it looks to improve its operating margins and grow the top line. The Chicago-area healthcare giant...
View ArticleOlympus pays $306m to settle kickbacks case
The U.S. Justice Department today reported that Olympus (TYO:7733) will pay approximately $306 million to 50 states, Washington D.C. and the federal government to resolve claims of kickbacks that...
View ArticleGE Healthcare inks strategic imaging deal with Heritage Valley Health System
Heritage Valley Health Systems said today it inked a strategic alliance with GE Healthcare (NYSE:GE) that will provide the group with MRI and CT scanners as well as other equipment from GE. The deal,...
View ArticlePureTech launches Alivio inflammation focused drug-delivery biz
PureTech Health said today it launched Alivio Therapeutics, a new novel tech business aiming to treat inflammatory disorders. The newly-launched company’s technology is based on hydrogel material...
View ArticleMassDevice.com +5 | The top 5 medtech stories for May 10, 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...
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