– Demonstrates statistically significant and clinically meaningful results – – Bempedoic acid becomes the first ATP citrate lyase inhibitor and first oral non-statin to meet the major adverse cardiovascular events (MACE-4) primary endpoint – – Presentation of comprehensive data at a key medical conference in the first quarter of 2023 – ANN ARBOR, […]
Author: Ken Dropiewski
Amarin Announces VAZKEPA® (icosapent ethyl) Receives Regulatory Approval in Switzerland
— Amarin Continuing Process for Obtaining National Pricing and Reimbursement in Switzerland in the Course of 2023 — — Swissmedic Approval Underpins Company’s Presence and Expansion in Switzerland as its Regional Commercial Hub for Europe — DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2022 (GLOBE NEWSWIRE) — Amarin Corporation plc […]
HeartBeam Partners with Evolve Manufacturing to Build HeartBeam AIMIGoTM 12-Lead 3D Vector Electrocardiogram Device
Partnership Positions AIMIGo for Early Market Testing in Q2 2023 After Expected FDA Clearance December 07, 2022 08:31 AM Eastern Standard Time SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, today […]
Acticor Biotech: Disclosure of the Total Number of Voting Rights and Shares as of November 30, 2022
PARIS–(BUSINESS WIRE)–Regulatory News: ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT), a clinical stage biopharmaceutical company dedicated to the development of innovative treatments for cardiovascular emergencies, including ischemic stroke, today discloses the total number of voting rights and shares as of November 30, 2022 (pursuant to Article L. 233-8 II of the […]
SIMPLEX QUANTUM, Inc. Raises Round of Series A Funding
Medical information technology company receives investment of JPY550 million TOKYO–(BUSINESS WIRE)–SIMPLEX QUANTUM, Inc. has raised JPY550 million in a round of Series A funding. Simplex Holdings, Inc., along with the Technology Ventures No. 5 Investment Limited Partnership managed by ITOCHU Technology Ventures (ITV), and ITOCHU Corporation, invested the funds. This investment […]
Acutus Medical Obtains MDR CE Mark of the AcQMap 3D Imaging and Mapping Catheter
The flagship 3D mapping catheter from Acutus Medical has been certified under the new European Medical Device Regulations CARLSBAD, Calif., Dec. 06, 2022 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus” or “the Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, […]
CORVIA MEDICAL ANNOUNCES RANDOMIZATION OF FIRST PATIENT IN THE RESPONDER-HF CONFIRMATORY TRIAL
Corvia® Atrial Shunt has the potential to change the way heart failure is treated TEWKSBURY, Mass., Dec. 6, 2022 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), announced the first patient has been randomized in RESPONDER-HF, a global confirmatory trial of the Corvia Atrial Shunt […]
Ultromics receives FDA Clearance for its Breakthrough Device EchoGo Heart Failure: An AI-based platform that enables precision detection of heart failure with preserved ejection fraction
EchoGo® Heart Failure revolutionizes the detection of HFpEF – the biggest unmet need in cardiovascular medicine.1 OXFORD, England, Dec. 6, 2022 /PRNewswire/ — Ultromics’ EchoGo® Heart Failure, an AI solution for echocardiography with the potential to revolutionize the diagnosis of heart failure with preserved ejection fraction (HFpEF), has received US Food and Drug […]
Henry Ford Health to Lead First-of-its-Kind National Trial for Innovative Heart Device
Clinical trial will enroll more than 3,000 patients across 75 participating hospitals in U.S. DETROIT, Dec. 6, 2022 /PRNewswire/ — Henry Ford Health will be spearheading a multi-center, first-of-its-kind national clinical trial dubbed the “CORRAL-AF IDE” study for an innovative left atrial appendage occlusion device known as the LAmbre™ Plus Left Atrial […]
FLEX Vessel Prep 12 Month AV Registry Data and 12 Month Belong PAD Data Shows Benefit to Micro-incisions Before Balloon or DCB Treatment
MINNEAPOLIS, Dec. 6, 2022 /PRNewswire/ — VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced data presented at the VEITH Symposium, Nov. 15-19th, New York, New York. Overall, the data presented demonstrated that FLEX Vessel […]



