January 2016

Polyganics wins FDA 510(k) clearance for Neurocap

by Fink Densford for MassDevice.com

Polyganics said today it won FDA 510(k) clearance for its Neurocap device, designed to reduce neuroma formation and facilitate tissue repair.

Neuromas, also known as pinched nerves or nerve tumors, are benign growths of nerve tissue that can cause pain, burning sensation, tingling or numbness, according to the company.

“Neuroma-induced neuropathic pain and morbidity can seriously affect the quality of a patient’s daily life. Neurocap, a transparent tubular device with a sealed...

FDA clears LifeWatch patch for remote cardiac monitoring patch

by Brad Perriello for MassDevice.com

LifeWatch (SWX:LIFE) said yesterday that it won 510(k) clearance from the FDA for its mobile cardiac telemetry patch, a 1-lead electrocardiograph system.

Zug, Switzerland-based LifeWatch said the MCT 1-lead patch is capable of “watching every heartbeat for adverse cardiac events and...

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...