Regulatory

MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions

NYON, Switzerland, March 4, 2021 /PRNewswire/ — MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained limus release DEB catheter, in the treatment of atherosclerotic lesions […]

ControlRad® Announces FDA Clearance for ControlRad Select

ATLANTA, March 4, 2021 /PRNewswire/ — ControlRad, Inc., a privately held medical technology company focused on dramatically reducing unnecessary radiation exposure during fluoroscopically guided procedures, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select. The technology utilizes proprietary semi-transparent filters, a user-interface tablet, and image processing algorithms, […]

FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation

Pioneering technology has demonstrated potential to improve safety for patients with paroxysmal atrial fibrillation and simplify procedures for physicians MENLO PARK, Calif., March 3, 2021 /PRNewswire/ – FARAPULSE Inc. today announced the first patients were treated in the ADVENT Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to […]

Cook Medical receives FDA Breakthrough Device Designation for Zenith® Fenestrated+ Endovascular Graft

Bloomington, Ind. — Cook Medical’s Zenith® Fenestrated+ Endovascular Graft (ZFEN+) product has received Breakthrough Device designation from the US Food and Drug Administration (FDA). This designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. While the […]

Vascular Graft Solutions Wins FDA approval to Market the VIOLA™ Clampless Proximal Anastomosis System for CABG

TEL AVIV, Israel, March 1, 2021 /PRNewswire/ — Vascular Grafts Solutions (VGS) Ltd. announced today receipt of marketing clearance from the Food and Drug Administration (FDA) for the VIOLA™, a new device for clampless proximal anastomosis in coronary artery bypass grafting (CABG) Neurocognitive dysfunction remains the most devastating perioperative complication of CABG […]

Inovise Receives Breakthrough Device Designation for Novel Non-Invasive System to Remotely Monitor Risk of Decompensation in Heart Failure Patients

PORTLAND, Ore., Feb. 23, 2021 /PRNewswire/ — Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure. […]

icometrix expands icobrain portfolio with ischemic stroke solution

LEUVEN, Belgium and BOSTON, Feb. 23, 2021 /PRNewswire/ — icometrix, world leader in imaging AI solutions for people with neurological conditions, announced the addition of icobrain cva, a stroke solution, to the icobrain portfolio. The announcement follows the FDA-clearance and CE-marking of its image processing software for the analysis and communication of the tissue perfusion state […]

Bracco Announces U.S. FDA Approval of 20-Vial Configuration of LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use

20-vial pack provides a green packaging alternative and helps increase storage efficiency MONROE TOWNSHIP, N.J., Feb. 22, 2021 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world’s leading companies in the diagnostic imaging business, announced today that its ultrasound enhancing agent (UEA) LUMASON® (sulfur hexafluoride lipid-type […]

Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease

Transformative Technology Now Available for Calcified Coronary Plaque SANTA CLARA, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the company’s sonic pressure wave therapy received Pre-Market Approval for […]

Novartis Entresto® granted expanded indication in chronic heart failure by FDA

Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3 Expanded indication enables potential treatment of more adults with […]