Regulatory

Humacyte Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Expedited Review Designation for HUMACYL® in Vascular Access for Hemodialysis

Press Release RESEARCH TRIANGLE PARK, N.C. — Humacyte, an innovator in biotechnology and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted HUMACYL®, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) […]

BioStable Science & Engineering Wins FDA Nod for Its HAART 300 Aortic Annuloplasty Device

BioStable Science & Engineering Announces FDA Clearance of the HAART™ 300 Aortic Annuloplasty Device AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available […]

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 […]