Regulatory

CardioFocus® Announces European CE Mark Approval Of The Next-Generation HeartLight® Excalibur Balloon™ Designed For The Treatment Of Atrial Fibrillation

MARLBOROUGH, Mass., Sept. 27, 2017 /PRNewswire/ — CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF). The Excalibur Balloon leverages the proven universal balloon design of the company’s FDA-approved HeartLight® Endoscopic Ablation System and introduces an advanced feature set that optimizes the speed […]

SurModics (SRDX) Nabs Global Approvals of .014″ Low-Profile PTA Balloon Dilation Catheter

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for […]

Gecko Biomedical receives CE Mark Approval for SETALUM™ Sealant

Approval of CE Mark paves the way for application expansion and the exploration of new therapeutic areas for ground-breaking surgical solutions. Paris, France, September 11, 2017 – Gecko Biomedical (“Gecko”), a medical device company developing innovative polymers to support tissue reconstruction, announced today that it has received CE Mark approval […]

Spectranetics Recalls Bridge Occlusion Balloons

Philips subsidiary Spectranetics recalls Bridge occlusion balloon AUGUST 31, 2017 BY BRAD PERRIELLO , MassDevice Royal Philips (NYSE:PHG) subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens. The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was […]

Implanted Cardiac Device: Newest Ransomware Target

by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) It has the makings of a plot for a blockbuster movie: a high ranking government official or world leader assassinated by a nefarious hacker who remotely accesses an implanted cardiac device. Plot lines and prominent world leaders notwithstanding, cyber-security risks for implantable cardiac […]

Cardiome Provides U.S. Regulatory Update For BRINAVESS

VANCOUVER, Aug. 21, 2017 /PRNewswire/ – Cardiome Pharma Corp. (NASDAQ: CRME/ TSX:COM) today announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory path for BRINAVESS® (vernakalant hydrochloride, IV), the Company’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF).  In its […]

QT Vascular begins enrollment in US pivotal study of its drug-coated peripheral balloon

SINGAPORE, July 31, 2017 /PRNewswire/ — QT Vascular Ltd., together with its subsidiaries (the “Company”), announced it has started enrollment in its United States (“US“) pivotal clinical study. The study will evaluate the Company’s drug coated balloon (“DCB“), the Chocolate Touch®, for use in superficial femoral and popliteal arteries with the intention of obtaining […]

Intact Vascular Release: FDA Approves 6-Month Primary Endpoint For The Tack Endovascular System In Below The Knee Disease

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial from 12 months to […]