Submitted by kBLASTER Team on
by Fink Densford for MassDevice.com
GE Healthcare (NYSE:GE) said today the FDA granted it 510(k) clearance for low-dose lung cancer screenings using its compatible computed tomography devices.
The Centers for Medicare and Medicaid services recommends the low-dose CT lung cancer screening and approved insurance...
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)...
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...
Submitted by kBLASTER Team on
By Stacy Lawrence 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...
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--(BUSINESS WIRE)--PhysIQ, a leader in developing solutions based on machine learning technology to revolutionize remote patient monitoring, has...
Submitted by kBLASTER Team on
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)...
Submitted by kBLASTER Team on
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)...
Submitted by kBLASTER Team on
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...
Submitted by kBLASTER Team on
By Hannah Corcoran for BONEZONE® (a division of ORTHOWORLD®)
After years of frustration using FDA’s 510(k) search function to prepare his own submissions, Eric Eggers felt there had to be a simpler, faster way. This drove him to create his own 510(k) search function called kBLASTER®, a tool...
Submitted by kBLASTER Team on