ALBANY, N.Y., March 14, 2017 (GLOBE NEWSWIRE) — AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology/surgery, today announced it has received CE Mark certification for the Solero Microwave Tissue […]
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) […]
Aegis Medical Innovations Announces FDA Approval of Clinical Trial
VANCOUVER, British Columbia–(BUSINESS WIRE)–Aegis Medical Innovations Inc. (Aegis) today announced that it has received Investigational Device Exemption approval from the U.S. FDA to initiate a clinical trial in the U.S. for its medical device called the Sierra Ligation System (Sierra). […]
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 […]
PQ Bypass Announces CE Mark for DETOUR Percutaneous Bypass Technologies
PQ Bypass Announces CE Mark for DETOUR Percutaneous Bypass Technologies Trio of proprietary technologies expands treatment options for patients with extremely long superficial femoral artery blockages due to peripheral artery disease March 13, 2017 08:00 AM Eastern Daylight Time SUNNYVALE, […]
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 […]