February 2016

BioFire Receives FDA 510(k) Clearance for FilmArray® Torch with FilmArray® Respiratory Panel and Submits Special 510(k) Applications for Use with additional FilmArray® Panels

by Business Wire

MARCY L’ETOILE, France--()--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular biology affiliate, has received Special 510(k)1 clearance from the U.S. Food and Drug Administration (FDA) to market the FilmArray® Torch for use with the FilmArray...

FUJIFILM Announces FDA 510(k) Clearance For Latest Innovation In PACS Technology: Synapse5

by PRNewswire

STAMFORD, Conn., Feb. 17, 2016 /PRNewswire/ -- FUJIFILM Medical Systems U.S.A., Inc. (a division of FUJIFILM Holdings Corporation OTC: FUJIY), a leading provider of diagnostic imaging products and medical informatics solutions, announced it has received FDA 510(k) clearance for the sale and distribution of its most recent innovation in PACS technology, Synapse 5. The latest offering of Fujifilm...

Fewer 510(k) Submissions from US Medical Device Firms in 2015

by Stewart Eisenhart at Emergo

In 2015, fewer US-based medical device companies submitted 510(k) applications to the Food and Drug Administration than at any point in the last five years.

Also last year, more 510(k) premarket notifications were submitted by foreign companies than at any point since at least 2011.

Overall 510(k) application numbers down

According to a new Emergo analysis of FDA 510(k) data, the number of 510(k) applications cleared by the FDA via...

With Special Tax Suspended, Medical Device Firms Reap Big Savings

by Mark Zdechlik for NPR

U.S. manufacturers of medical devices started 2016 with a windfall — a two-year suspension of a controversial tax on their revenue.

Medical devices include a wide range of products and machines used in medical care, such as tongue depressors, endoscopes and MRI scanners, for example. Manufacturers...

Zimmer Biomet Announces FDA 510(k) Clearance for Unite3D™ Bridge Fixation System

by PRNewswire

WARSAW, Ind., Feb. 11, 2016 /PRNewswire/ -- Zimmer Biomet Holdings (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, is pleased to announce that the Company has received 510(k) clearance from the U.S. Food and Drug Administration for the Unite3D™ Bridge Fixation System, a groundbreaking 3D-printed technology designed to offer stability in foot and ankle arthrodesis (joint fusion) surgery. Featuring Zimmer...

kBLASTER update February 2016: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from January 2016 and FDA 510(k) splash pages for 510(k)s clearances in February 2016. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  


LifeWatch wins FDA 510(k) clearance for vital sign monitoring

by Fink Densford for MassDevice

Swiss remote diagnostic monitoring company LifeWatch said today it received FDA 510(k) clearance for its Vital Signs monitoring service.

The service operates using wireless, patch-based vital signs monitors to allow for early detection of vital signs to enable more timely interventions, which the company claims leads to increased nursing efficiency and higher patient satisfaction.

“This clearance represents another significant technological breakthrough for LifeWatch and further...

NEWS FLASH--Biogaming LTD. gains 510(k) clearance for YuGo for Optical Position/Movement Recording for physical therapy

Israeli based Biogaming LTD. received 510(k) clearance on February 5, 2016 for their YuGo system for Optical Position/Movement Recording of patients for physical therapy purposes.

Save time with kBLASTER's unique result management features of sorting, My Favorites, Saved Search and Search History from a web browser, so either mobile devices or computers can be used to quickly find your primary predicate, multiple predicates or ...