Regulatory

FDA Green Lights Medtronic (MDT)’s CoreValve Evolut Pro Transcatheter Valve With Advanced Sealing

Press Release Medtronic Receives FDA Approval for CoreValve(TM) Evolut(TM) Pro Transcatheter Valve with Advanced Sealing DUBLIN – March 22, 2017 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM)Evolut(TM) PRO […]

Toshiba Medical Systems’ New Premium Cardiovascular Ultrasound Wins FDA Approval

Toshiba Medical’s New Premium Cardiovascular Ultrasound Receives FDA Clearance The Aplio i900 Delivers Fast, High Quality Images for Better Diagnostic Confidence TUSTIN, Calif.–(BUSINESS WIRE)–Cardiologists can now access the advanced ultrasound imaging technology needed for fast and confident diagnoses with Toshiba […]

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 […]

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 […]

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 […]

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 […]