Regulatory

AV Medical’s Chameleon receives expanded indication to include infusion of diagnostic or therapeutic fluids

TEL AVIV, Israel–(BUSINESS WIRE) AV Medical Technologies announced on 27 February 2017 that its Chameleon PTA balloon catheter has received FDA clearance for an expanded indication to include infusion of diagnostic or therapeutic fluids. “The Chameleon balloon offers advantages for experienced operators as well as those training in dialysis access […]

Teleflex (TFX) Announces 510(k) Clearance and U.S. Launch of Spectre™ Guidewire

View source version on businesswire.com:  http://www.businesswire.com/news/home/20170314005152/en/ Teleflex Incorporated (TFX), a leading global provider of medical technologies for critical care and surgery, has announced 510(k) clearance by the Food and Drug Administration and U.S. commercial launch of the Spectre Guidewire. The Spectre Guidewire is engineered with a smooth stainless steel-to-nitinol dual-core […]

Tryton medical receives FDA approval for Tryton side branch stent to treat significant coronary bifurcation lesions

PCRonline/News/Industry Press Releases Tryton stent is the first dedicated bifurcation device to receive regulatory approval in the U.S. Cordis to be exclusive U.S. distributor of the Tryton stent. DURHAM, N.C. – Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, today announced the U.S. Food […]

Keystone Heart Applauds FDA Advisory Panel for Recognition of The Need for Cerebral Protection Following TAVR

CAESAREA, Israel and TAMPA, Fla., Feb. 27, 2017 /PRNewswire/ — Keystone Heart Ltd., an emerging medical device company focused on developing cerebral embolic protection devices for patients undergoing cardiac procedures, applauds the members of the FDA’s Circulatory System Devices Panel that convened this past week for their acknowledgement of the […]