Toshiba deals medical biz to Canon for $5.9B as U.S. authorities launch...
Toshiba (TYO:6502) said yesterday that it inked a deal to sell its medical device business to Canon (NYSE:CAJ) for $5.9 billion, as the U.S. Justice Dept. and the SEC probed the accounting practices in...
View ArticleIMARC launches new clinical research services
IMARC, a clinical research organization, is introducing new services designed to better assist research professionals as they secure regulatory approval. IMARC has been a trusted source of independent...
View ArticleColombian regulators now consider medical displays medical devices
By Stewart Eisenhart, Emergo Group INVIMA, the Colombian medical device market regulator, has announced that medical displays are now considered Class IIa medical devices subject to registration...
View ArticleIntegrating usability engineering into your medical device design process
The Landscape is Changing… The FDA recently finalized their guidance on how human factors and usability engineering should be applied in the design process for medical devices. While this may be new to...
View ArticleAnalyst: Medtronic most likely to challenge Intuitive Surgical in...
Medtronic (NYSE:MDT) is the most likely rival to Intuitive Surgical‘s (NSDQ:ISRG) dominance in the robot-assisted surgery space, but is still at least a year away from putting a competing device on the...
View ArticleMedtronic looks to open board to shareholders
Medtronic (NYSE:MDT) proposed today to allow long-term shareholders to nominate candidates for its board of directors, saying it will ask stockowners to approve the measure at its annual meeting in...
View ArticlePavmed extends $6m IPO
Pavmed said earlier this week it will extend its heavily reduced $6 million IPO an additional 45 days. The IPO was dramatically reduced in January, with the company announcing that it planned to float...
View ArticleFDA: Verathon recall of video laryngoscope is Class I
The FDA today labeled a recall notice from Verathon for its GlideScope Titanium single-use video laryngoscope due to issues with potential video feed disruption. Class I recall designations, the...
View ArticleSirtex slides on sales veep’s exit
SirTex Medical saw share prices fall as much as 7.2% to trade at $21.36 (AUD $28.10), the lowest it’s been in 9 months, after announcing today that its Americas prez Mike Mangano is set to leave at the...
View ArticleLIM Innovations wins CMS reimbursement for Infinite Socket
LIM Innovations said today it won reimbursement coverage from the Centers for Medicare and Medicaid Services for it Infinite Socket prosthetic socket device. The Infinite Socket is a custom-molded...
View ArticleClarius claims 1st portable ultrasound for iPhone, Android
Mobile ultrasound developer Clarius Mobile Health said yesterday it released the 1st smartphone-connected portable ultrasound scanner designed to work with Apple IOS and Google Android devices. The...
View ArticleMassDevice.com +5 | The top 5 medtech stories for March 18, 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 ArticleNow there’s proof: Docs who get company cash tend to prescribe more...
by Charles Ornstein, Ryann Grochowski Jones and Mike Tigas, ProPublica. Doctors have long disputed that the payments they receive from pharmaceutical companies have any relationship to how they...
View ArticleJohnson & Johnson looks to settle morcellator lawsuits
Johnson & Johnson(NYSE:JNJ) is reportedly looking to settle 100s of product liability and wrongful death lawsuits brought over its now-recalled laparoscopic power morcellators used during surgeries...
View ArticleFDA and NIH release a draft clinical trial protocol template for public comment
By: Peter Marks, M.D., Ph.D. Enhancing important efforts around clinical trials continues to be a key scientific priority. Another way we can encourage clinical trials is to look for ways to help...
View ArticleJudge: Doc can’t drag Globus into patent spat with Medtronic
A doctor suing Medtronic (NYSE:MDT) for allegedly infringing his patents covering spinal deformity repair devices can’t drag Globus Medical (NYSE:GMED) into the dispute, a federal judge in Pennsylvania...
View ArticleCardiovascular Systems to settle lawsuit for $8m
Cardiovascular Systems (NSDQ:CSII) said today that it agreed to an $8 million settlement with the plaintiff in a False Claims Act lawsuit based on allegations from a former sales rep that the company...
View ArticleMedinol launches trial for NIRxcell stent
Medinol said it enrolled the 1st U.S. patient in a post-market study of its bare-metal NIRxcell stent, which has been on the U.S. market since January 2015. Tel Aviv-based Medinol said the NIRxcell...
View ArticleB. Braun, ICU Medical ink long-term distro deal
ICU Medical (NSDQ:ICUI) said today it inked a long-term distribution deal with B. Braun Medical for ICU’s SwabCap disinfecting cap for needlefree connectors for select countries outside the U.S. San...
View ArticleSenate bill would streamline FDA’s medical device reviews
A bipartisan duo in the U.S. Senate introduced a bill last week that aims to streamline the way the FDA reviews medical devices. Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) introduced...
View Article