May 2016

Bone Index Receives FDA 510(k) Clearance for the Bindex® Point-of-care Instrument to Help Physicians in Diagnosing Osteoporosis

by PR Newswire

Bone Index Ltd., one of Europe's top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for the Bindex® point-of-care instrument to help in osteoporosis diagnosis.

Osteoporosis, a very underdiagnosed disease, is responsible for two million broken bones every year in the USA. These fractures translate into costs totaling about 19 billion dollars. Experts forecast that by 2025, the costs due to fractures will rise to 25.3 billion...

kBLASTER update May 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 April 2016 and FDA 510(k) splash pages for 510(k)s clearances in May 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).  

Leverage ...

Another FDA 510(k) clearance for Synaptive Medical with its ImageDrive Pro

by Fink Densford for

Synaptive Medical said it won FDA 510(k) clearance for its ImageDrive Pro informatics system designed to integrate its existing BrightMatter technology into multiple platforms.

The company said the new platform will allow for interoperability across all of BrightMatter’s solutions, including imaging, surgical planning, navigation and automated positioning of high definition optics.

BrightMatter gives 3D visuals of the brain in the operating room, which help guide surgeons as they...

FDA 510(k) Clears Next-Generation Version of EndoGastric Solutions’ EsophyX® Device

by Business Wire

REDMOND, Wash.--()--EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EsophyX® Z device.

Designed for compatibility with the company’s existing 7.5 mm SerosaFuse...

FDA 510(k) Clears CareTaker® Wireless Remote Patient Monitor For Continuous Non-Invasive Blood Pressure (“cNIBP”) and Heart Rate Monitoring using patented Finger Cuff Technology

by Caretaker Medical

Charlottesville, VA April 2016 — CareTaker Medical, a pioneer in wireless remote patient monitoring devices, announced that the U.S. Food and Drug Administration has issued 510(k) clearance for the company’s Wireless Continuous Non-Invasive “Beat-by-Beat” Blood Pressure (“cNIBP”) and Heart Rate Monitor, based on patented Finger Cuff technology.

The wearable CareTaker® monitor enables uninterrupted wire-free and...