Submitted by kBLASTER Team on
by Mark Zdechlik for NPR
U.S. manufacturers of medical devices started 2016 with a windfall — a two-year suspension of a controversial tax on their revenue.
Medical devices include a wide range of products and machines used in medical care, such as tongue depressors, endoscopes and MRI scanners, for example. Manufacturers...
Submitted by kBLASTER Team on
by PRNewswire
WARSAW, Ind., Feb. 11, 2016 /PRNewswire/ -- Zimmer Biomet Holdings (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, is pleased to announce that the Company has received 510(k) clearance from the U.S. Food and Drug Administration for the Unite3D™ Bridge Fixation System, a groundbreaking 3D-printed technology designed to offer stability in foot and ankle arthrodesis (joint fusion) surgery. Featuring Zimmer...
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with FDA 510(k) clearances from January 2016 and FDA 510(k) splash pages for 510(k)s clearances in February 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).
Submitted by kBLASTER Team on
by Fink Densford for MassDevice
Swiss remote diagnostic monitoring company LifeWatch said today it received FDA 510(k) clearance for its Vital Signs monitoring service.
The service operates using wireless, patch-based vital signs monitors to allow for early detection of vital signs to enable more timely interventions, which the company claims leads to increased nursing efficiency and higher patient satisfaction.
“This clearance represents another significant technological breakthrough for LifeWatch and further...
Submitted by kBLASTER Team on
Israeli based Biogaming LTD. received 510(k) clearance on February 5, 2016 for their YuGo system for Optical Position/Movement Recording of patients for physical therapy purposes.
Save time with kBLASTER's unique result management features of sorting, My Favorites, Saved Search and Search History from a web browser, so either mobile devices or computers can be used to quickly find your primary predicate, multiple predicates or ...
Submitted by kBLASTER Team on
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...
Submitted by kBLASTER Team on
by BusinessWire
MADISON, Wis.--(BUSINESS WIRE)--HealthMyne, an imaging informatics company, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA). The new analytics software package is...
Submitted by kBLASTER Team on
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...
Submitted by kBLASTER Team on
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).
Submitted by kBLASTER Team on
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...