August 2015

FDA 510(k) clears MagVenture’s MagVita TMS

Submitted by kBLASTER Team on

by Fink Densford at MassDevice.com

Non-invasive magnetic stimulation developer MagVenture said last month it won FDA 510(k) clearance for its MagVita transcranial magnetic stimulation therapy system.

The device, which uses magnetic fields and electric currents to excite and depolarize neurons in the brain and nervous system, is indicated for treating major depressive disorder in patients non-receptive to antidepressant medication, the company said.

“I am very pleased to hear of the clearance by the FDA of the MagVenture...

Medeon Biodesign Receives FDA 510(k) Clearance for ClickClean(TM) - Laparoscope Lens Cleaning Device

Submitted by kBLASTER Team on

by PRNewswire

LOS ALTOS, Calif. and TAIPEI, Aug. 25, 2015 /PRNewswire/ -- Medeon Biodesign, Inc., a Taiwan medical device company, is pleased to announce that the company has received U.S. Food and Drug Administration 510(k) clearance for ClickClean™, a lens cleaning device. ClickClean provides instant, in-situ, one-click lens cleaning during laparoscopic...

Tyber Medical wins FDA 510(k) clearance for TyWedge

Submitted by kBLASTER Team on

by Fink Densford for MassDevice.com

Tyber Medical said Wednesday it won FDA 510(k) clearance for its TyWedge osteotomy wedge system.

The TyWedge is a titanium plasma sprayed PEEK indicated for fusion in osteotomy operations, and allows for angular corrections in the foot, according to the Morristown, N.J.-based company.

“The TyWedge system marries...

FDA Touts Faster Medical Device Approval Times

Submitted by kBLASTER Team on

by Jof Enriquez for Med Device Online

The U.S. Food and Drug Administration (FDA) claims it has approved medical devices markedly faster in the last five years than in the preceding decade. The agency attributes the improvement to its decades-old mandate, as well as more recent actions designed to facilitate approvals.

"These improvements include those to 510(k) and premarket approval (PMA) review times along with a reduction in Investigational Device Exemption (IDE) review times of almost a full year — which means many devices investigated in the United States now...

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

Submitted by kBLASTER Team on

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

With more than 61,000 510(k)...

Zyga wins 510(k) clearance for Simmetry fusion system

Submitted by kBLASTER Team on

by Fink Densford for MassDevice.com

Zyga Technology said today it won 510(k) clearance from the FDA for its Simmetry sacroiliac joint fusion system for single or 2-incision indications.

Based in Minnetonka, Minn., Zyga develops minimally invasive surgical products for the treatment of lumbar spinal conditions.

“In the operating room, surgeons need as many options as...

Ulthera nabs FDA nod for cellulite treatment, to launch in the fall

Submitted by kBLASTER Team on

By  for Fierce Medical Devices

The FDA has given aesthetic medical device player Ulthera, a subsidiary of Merz, a 510(k) clearance for its Cellfina System that it said is the longest that the agency has bestowed for a cellulite treatment. It is cleared to improve the appearance of cellulite on the...

PhysIQ Personalized Physiology Analytics Engine Software Receives First FDA 510(k) Clearance

Submitted by kBLASTER Team on

Represents next generation of personalized digital health and promise of precision medicine, extracting intelligence from real-time patient data

by Physiq

CHICAGO, IL--()--PhysIQ, a leader in developing solutions based on machine learning technology to revolutionize remote patient monitoring, has...