Regulatory

Infraredx, a Nipro Company, Announces FDA Approval of Expanded Label Claim for the Makoto™ Intravascular Imaging System

BURLINGTON, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for use for its Makoto™ Intravascular Imaging System. The approval is based on the […]

Quantum Genomics Receives First Regulatory and Ethics Approvals to Initiate Phase IIb QUORUM Study of Firibastat in Heart Failure

PARIS and NEW YORK, April 17, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth: ALQGC, OTCQX: QNNTF), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the first regulatory and ethics approvals for its Phase […]

Intact Vascular’s Tack Endovascular System® Receives FDA Approval

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD). […]

TherOx Receives FDA Approval for First Heart Attack Treatment Since PCI to Reduce Infarct Size

IRVINE, Calif.–(BUSINESS WIRE)–TherOx, Inc., a privately held medical device company focused on improving treatment of acute myocardial infarction (AMI), announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous […]

CMS Makes Progress but Continues to Limit Life-Saving Access for Heart Valve Disease Patients

WASHINGTON, March 27, 2019 /PRNewswire/ — Alliance for Aging Research, Association of Black Cardiologists, Heart Valve Voice US, and Mended Hearts issued a joint statement today in response to the Centers for Medicare and Medicaid Services’ proposed decision to cover Transcatheter Aortic Valve Replacement for the treatment of symptomatic aortic valve stenosis through […]

Genetesis CardioFlux™ Platform Receives FDA 510(k) Clearance

MASON, Ohio–(BUSINESS WIRE)–Genetesis, a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage, has received FDA 510(k) clearance for its cardiac imaging platform. The platform pairs the CardioFlux™ Magnetocardiograph with the integrated Faraday Analytical Cloud™ (FAC). “This milestone provides emergency room physicians […]

BD Statement on Paclitaxel-Coated Devices

FRANKLIN LAKES, N.J., March 21, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement related to the recent letter from FDA to health care providers regarding paclitaxel-coated devices: On March 15, the FDA issued a letter to health care providers regarding paclitaxel-coated devices […]

Impulse Dynamics Receives FDA Approval for Breakthrough Optimizer® Smart System Delivering CCM™ Therapy for Treatment of Heart Failure

ORANGEBURG, New York, March 21, 2019 /PRNewswire/ — Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System (link to FDA announcement:  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm). Designed to address a significant unmet […]

FDA approves new device for treating moderate to severe chronic heart failure in patients

SILVER SPRING, Md., March 21, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. […]