December 2015


by GI Logic

GI Logic, a privately held gastroenterology medical device company, announced today it has received FDA 510K clearance for the AbStats™ System to be used by physicians in hospitals and other healthcare settings for non-invasive, real time telemetry of the digestive system.

Recovery after surgery is frequently associated with diminished gastrointestinal function because anesthesia, pain medications and the surgery itself “shuts down” the digestive system. As a...

Viatom gets FDA 510(k) clearance for Checkme vitals monitoring device

by MedGadget

The Checkme Pro portable health monitor from Viatom Technology, a company out of Shenzhen, China, has been 510(k) cleared by the FDA. The device performs one-lead ECG recording, pulse oximetry, temperature measurement, and movement sensing. There’s also cuffless systolic blood pressure measurement that relies on calibration, but this part has not been included in the U.S. version.

The ECG is capable of providing QRS duration, ST segment, and rhythm analysis for basic cardiac monitoring of patients,...

kBLASTER update December 2015: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from November 2015 and FDA 510(k) splash pages for 510(k)s clearances in December 2015. 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).  


Qfix Receives 510(k) Clearance for Encompass™ SRS Immobilization System

by PR Newswire

AVONDALE, Pa., Dec. 4, 2015 /PRNewswire/ -- Today, Qfix, a world leader in radiotherapy patient positioning devices, announced the Encompass™ SRS Immobilization System has received 510(k) clearance from the US FDA for stereotactic radiosurgery (SRS). The Encompass has been used for intracranial radiotherapy treatments for nearly a year and is now cleared to achieve sub-millimeter immobilization to precisely treat multiple lesions with a single isocenter. "We are delighted to receive FDA...

FDA 510(k) clears Philosys Gmate glucometer for Android

by Fink Densford for

Medical and diagnostic device developer and manufacturer Philosys said today it won FDA 510(k) clearance for its Gmate Smart blood glucose monitoring system and associated application for Google (NSDQ:GOOG) Android devices.

The Gmate Smart is designed to plus into the headphone jack on compatible smartphones to provide blood glucose test results, the New York-based...