News

Zyga wins 510(k) clearance for Simmetry fusion system

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

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

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...

kBLASTER update July 2015 #2: 510(k) search for predicates and successful 510(k) clearance strategy

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

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

Theranos receives FDA 510(k) clearance and review and validation of revolutionary finger stick technology, test, and associated test system

by Theranos

PALO ALTO, Cal. (July 2, 2015) – Theranos, Inc. (Theranos) today announced that it has received the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of its test system and test for herpes simplex 1 virus IgG. The FDA’s decision provides independent validation of Theranos’ patented finger stick and venous blood testing technology and the ground breaking Theranos System upon which the HSV-1 IgG test is run, as...

SomnoMed Receives FDA 510(k) Clearance for SomnoDent Devices with Wearable Complicance Micro-Recording

 
by Finance News Network
 
SomnoMed Limited (ASX: SOM:AX) announced today that it had received FDA 510(k) clearance to commercialize their wearable SomnoDent devices fitted with DentiTrac® Micro-Recorders. SomnoMed is the first and only company in the world...

kBLASTER update June 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 May 2015 and FDA 510(k) splash pages for 510(k)s clearances in June 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 60,000 510(k)...

FDA grants 510(k) clearance for Breathe Technologies Life2000 mechanical ventilation system

by Healio Pulmonology

Breathe Technologies has received 510(k) clearance from the US Food and Drug Administration for a mechanical ventilation system, according to a company press release.

The Breathe Technologies Life2000 Ventilation System is intended to provide continuous or intermittent ventilator support for the care of adult patients who require ...

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