News

Ceterix Orthopaedics wins FDA 510(k) clearance for NovoStitch Plus

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by Fink Densford for MassDevice.com

Ceterix Orthopaedics said today it won FDA 510(k) clearance for its NovoStitch Plus meniscal repair system designed for patients with meniscal tearing.

The device is a next-generation version of the company’s NovoStitch, designed to treat a variety of different meniscal tears, the Menlo Park, Calif.-based company said.

“The main difference is the NovoStitch Plus has a cartridge-based system and the cartridge has an...

kBLASTER update September 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 August 2015 and FDA 510(k) splash pages for 510(k)s clearances in September 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 nearly 62,000 510(k)...

Philips Receives FDA 510(k) Clearance for Spectral Diagnostic Suite

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by Philips

ANDOVER, MA – Reinforcing its commitment to improving diagnostic confidence through innovation, Royal Philips (NYSE: PHG AEX: PHIA) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Spectral Diagnostic Suite (SpDS). Philips SpDS is a set of advanced visualization and analysis tools designed for the Philips IQon Spectral CT to...

Eko gets greenlight from FDA for digital stethoscope

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By Stephanie Baum for MedCityNews.com

Medical device company Eko got the greenlight from the FDA with a 510(k) clearance for its Class 2 medical device — digital stethoscope Eko CORE, according to a company statement. It wirelessly streams heart sounds to a smartphone app and integrates heart sounds directly into the patient’s electronic health record. The goal is to support physicians...

Bovie Medical Receives FDA 510(k) Clearance for New J-Plasma® Pistol Grip Configurations

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by Business Wire

CLEARWATER, Fla.--()--Bovie Medical Corporation (“Bovie” or the “Company”) (NYSE:BVX), a maker of medical devices and supplies and the developer of J-Plasma®, a patented new surgical product, announced today that it has received FDA 510(k) approval for six new hand piece configurations that expand its J...

FDA 510(k) clears MagVenture’s MagVita TMS

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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

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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

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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

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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...

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