Regulatory

Windtree Announces FDA Fast Track Designation for Istaroxime

WARRINGTON, Pa., Aug. 13, 2019 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for istaroxime for the […]

Philips’ response to updated FDA letter to healthcare providers on paclitaxel devices to treat peripheral artery disease

Amsterdam, The Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its response to the U.S. Food and Drug Administration’s (FDA) Letter to Health Care Providers regarding treatment of peripheral artery disease (PAD) in the superficial femoropopliteal artery (SFA) with paclitaxel-coated devices.    Importantly, the FDA recommendation continues […]

Amarin Announces FDA Notification of Advisory Committee Meeting Planned to be Held in November 2019 in Connection With Vascepa® REDUCE-IT™ sNDA

PDUFA Date Extension to End of December 2019 Expected Management to Host Conference Call Today at 7:00 p.m. ET BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 08, 2019 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, announced today that it received notice today from the […]

B. Braun Interventional Systems Receives Breakthrough Device Designation Status from the FDA for SeQuent Please ReX Drug Coated PTCA Balloon Catheter

BETHLEHEM, Pa., Aug. 01, 2019 (GLOBE NEWSWIRE) — B. Braun Interventional Systems Inc. (BIS) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR). SeQuent Please ReX is […]

Endotronix Announces FDA Approval to Begin Landmark PROACTIVE-HF Pivotal Trial for Cordella™ PA Pressure Sensor System

LISLE, Ill., Aug. 1, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the multi-center PROACTIVE-HF trial of the Cordella™ Pulmonary […]

PhysIQ Inc. Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm Enabling Artificial Intelligence-based Analytics for Biopharma Companies and Payers

FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms Clearance allows physIQ to power its higher-level AI analytics with validated vital sign inputs PhysIQ’s cloud-based analytics provide flexibility to biopharma companies and payers looking for consistent output while deploying a variety of devices across […]

Dassault Systèmes and the FDA Extend Collaboration to Inform Cardiovascular Device Review Process and Accelerate Access to New Treatments

An in silico clinical trial is underway with the 3DEXPERIENCE platform to evaluate the Living Heart simulated 3D heart for transforming how new devices can be tested Five-year extension of their collaborative research agreement aims to spur medical device innovation by enabling innovative, new product designs Both Dassault Systèmes and […]

Q’Apel Medical Announces FDA Clearance for Walrus Balloon Guide Catheter

FREMONT, Calif., July 17, 2019 /PRNewswire/ — Q’Apel Medical announced today that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC). In the neurovascular space where speed, reliability and performance are so critical to patient outcomes, physicians and patients demand that innovative technologies are best-in-class. The walrus BGC, […]

LivaNova Receives U.S. FDA 510(k) Clearance for LifeSPARC Advanced Circulatory Support System

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. Derived from more than 20 years of life support experience with TandemLife, LifeSPARC […]

FDA approves Bayer’s Gadavist® (gadobutrol) injection as the first and only contrast agent for use in cardiac MR in adult patients with known or suspected coronary artery disease

WHIPPANY, N.J., July 15, 2019 /PRNewswire/ — Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Gadavist is […]