Clik here to view.
FDA clears St. Jude Medical’s EnSite Precision heart map, Advisor FL catheter
St. Jude Medical (NYSE:STJ) said today that it won 510(k) clearance from the FDA for its EnSite Precision cardiac mapping system and the Advisor FL catheter used with it. The Ensite cardiac mapping...
View ArticleClik here to view.
Galderma wins FDA nod for dermal fillers
Galderma said today that it won FDA approval for 2 of its products to treat nasolabial folds, or “laugh lines”. The Fort Worth, Texas-based company’s Restylane Refyne and Restylane Defyne are made...
View ArticleClik here to view.
TiGenix IPO raises $36m
TiGenix (EBR:TIG) said today that it raised $36 million in an initial public offering from the sale of 2.3 million American depository shares, representing 46 million ordinary shares, at $15.50...
View ArticleClik here to view.
BD launches high volume syringe for biologics
Becton Dickinson (NYSE:BDX) said today that it launched its BD Neopak 2.25 milliliter prefillable glass syringe designed for high-volume injection of biologics. The Franklin Lakes, N.J.-based company...
View ArticleClik here to view.
Baxter to put up $625m for Claris Injectables generics biz
Baxter (NYSE:BAX) said today that acquired Claris Lifesciences (BOM:533288) subsidiary Claris Injectables for $625 million. The deal is expected to close in the 2nd half of next year. Deerfield,...
View ArticleClik here to view.
Ex pharma execs first to be charged in generic drug pricing case
Former Heritage Pharmaceuticals CEO Jeffrey Glazer and ex-president Jason Malek were hit yesterday with the 1st criminal charges from a 2-year federal investigation in an ongoing generic drug pricing...
View ArticleClik here to view.
Best of 2016: Top 10 regulatory stories
In a year of huge product debuts from major medical device players, a dark horse was the most-read regulatory story of 2016: Obalon Therapeutics and the weight-loss device it developed won that title...
View ArticleClik here to view.
Best of 2016: The 10 most-read stories of the year
Each year, the editor’s of MassDevice write roughly 2,500 stories about the medical technology industry. These articles touch on the wins, the losses, the extraordinary and, sometimes, mundane...
View ArticleClik here to view.
Lilly, Boehringer’s Basaglar long-acting insulin now available in the U.S.
Eli Lilly (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals said today that its insulin glargine injection, Basaglar, is available by prescription in the U.S. Basaglar is a long-acting insulin with...
View ArticleClik here to view.
FDA denies Milestone Scientific’s Compu-Flo 510(k) application
Milestone Scientific‘s (OTC:MLSS) said today that the FDA denied the 510(k) application for its Compu-Flo intra-articular computer controlled injection system due to inadequate documentation showing...
View ArticleClik here to view.
ClearLine wins CE Mark for intravenous line device
ClearLine MD said today that it won CE Mark approval for its ClearLine IV product line that prevents air from being introduced into intravenous lines. During IV infusion, ClearLine’s device detects air...
View ArticleClik here to view.
MassDevice.com +5 | The top 5 medtech stories for December 15, 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 ArticleClik here to view.
Researchers use nanoparticles to overcome treatment-resistant breast cancer
Researchers from the University of Cincinnati College of Medicine have developed RNA nanoparticles that show promise in overcoming treatment-resistant breast cancer. The team’s work was published in...
View ArticleClik here to view.
EnteroMedics touts real-world vBloc data
EnteroMedics (NSDQ:ETRM) today released a real-world assessment of weight loss data from patients using its Maestro vBloc therapy device and associated programs, touting between 9% and 10% total weight...
View ArticleClik here to view.
Sanovas launches SteriView subsidiary aiming to fight hospital-acquired...
Sanovas said yesterday it launched another subsidiary, SteriView, along with its SteriView instrument inspection and infection control system. The newly launched system is designed as a “front line...
View ArticleClik here to view.
StimGuard launches OAB neurostim trial
StimGuard said today it enrolled the 1st patient in a clinical trial of its StimGuard miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder...
View ArticleClik here to view.
New medical device registration requirements issued in South Africa
By Stewart Eisenhart, Emergo Group The South African Department of Health has issued new regulatory requirements covering both medical devices and in vitro diagnostic (IVD) devices, according to...
View ArticleClik here to view.
SMC acquires UK auto-injector developer Oval Medical Technologies
SMC Ltd., said today that it acquired auto-injector developer Oval Medical Technologies for an undisclosed amount. Cambridge, UK-based Oval Medical Technologies develops auto-injectors for a 2-step...
View ArticleClik here to view.
Fresenius expands prefilled syringe portfolio
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it added its heparin sodium injection to the company’s Simplist prefilled syringe portfolio. The prefilled syringe for subcutaneous...
View ArticleClik here to view.
Mylan launches first generic EpiPen as state AGs sue generics makers for...
Mylan (NSDQ:MYL) launched its 1st generic EpiPen emergency allergy treatment 1 day after attorney generals from 20 states filed a civil complaint against Mylan, Teva Pharmaceuticals (NYSE:TEVA), and 4...
View Article
