News

kBLASTER update January 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 December 2015 and FDA 510(k) splash pages for 510(k)s clearances in January 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).  

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Bio2 Technologies, Inc. Announces Receipt of FDA 510(k) Clearance for a Fusion Implant System for Extremities Surgery

by PRNewswire

WOBURN, Mass., Jan. 11, 2016 /PRNewswire/ -- Bio2 Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its Fusion Implant system for interphalangeal fusion, fracture repair and osteotomies of the toes, fingers and other small bones in the presence of appropriate immobilization.  The implants are constructed with Bio2's Vitrium biomaterial exclusively composed of bioactive glass, a resorbable material...

NeuroMetrix Announces FDA 510(k) Clearance of Next Generation Quell® Wearable Pain Relief Technology at the 2016 Consumer Electronics Show

by BusinessWire

WALTHAM, Mass.--()--NeuroMetrix, Inc. (Nasdaq: NURO) announced today that it received a 510(k) clearance (K152954) from the U.S. Food and Drug Administration (FDA) for an upgraded version of Quell, the company’s over-the-counter, 100% drug free chronic pain relief wearable. Under this 510(k), the Quell device can be controlled directly...

GI LOGIC RECEIVES FDA 510(K) CLEARANCE FOR THE ABSTATS™ SYSTEM FOR REAL-TIME DIGESTIVE TELEMETRY

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).  

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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 MassDevice.com

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...

Covalon Announces FDA 510(k) Clearance for Its New SilverCoat™ Silicone Foley Catheter

by Newswire

MISSISSAUGA, ON, Nov. 30, 2015 /CNW/ - Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV), an advanced medical technologies company, announces United States Food and Drug Administration ("FDA") 510(k) clearance of its new SilverCoatTM Silicone Foley Catheter that is designed to allow clinicians to drain a patient's bladder, help reduce the...

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