Author: Ken Dropiewski

Acarix submits breakthrough designation request with FDA for heart failure diagnosis

Malmö, Sweden, February 9, 2022 Acarix submits breakthrough designation request with FDA for heart failure diagnosis  Acarix expands its portfolio and submits a breakthrough designation request for its innovative technology for heart failure diagnosis with the Food and Drug Administration (FDA) in USA. Heart failure affects more than 6 million people in the USA at […]

Claritas Anticipates Response from Australian Ethics Committee by February 18, 2022

Ethics Committee Approval is Final Step Prior to Enrollment of Claritas’ Phase 1 Clinical Study of R-107 SAN FRANCISCO, CA and TORONTO, ON, Feb. 09, 2022 (GLOBE NEWSWIRE) — Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the “Company” or “Claritas“) today announced that the Australian Human Research Ethics […]

Philips expands access to hemodynamics at point-of-care for real-time blood flow assessment on Handheld Ultrasound – Lumify

Philips point-of-care ultrasound technology now includes Pulse Wave Doppler for all physicians – from cardiologists and radiologists to emergency care – to quickly assess hemodynamics in cardiac function anytime, anywhere Lumify is also the first and only handheld ultrasound with B-lines software and smart algorithms to enhance heart and lung […]

Silence Therapeutics Announces Positive Topline Data in SLN360 Phase 1 Single-Ascending Dose Study in Healthy Adults with High Lipoprotein(a)

SLN360, an investigational siRNA to reduce risk of Lp(a)-mediated cardiovascular disease, was safe and well tolerated in the study SLN360 significantly lowered Lp(a) in a dose-dependent manner up to 98% with reductions of up to 81% persisting at 150 days Results to be presented in late breaker at the American […]

atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial

Company’s reSept™ ASD Occluder Aims to Evolve Septal Closure with its Novel Metal-Free Frame Design BAAR, Switzerland and SANTA CLARA, Calif., Feb. 8, 2022 /PRNewswire/ — atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced it has received approval for the start […]

MedHub Announces completion of its pivotal multi-center validation study and raises $1 million in new financing

TEL AVIV, Israel, Feb. 8, 2022 /PRNewswire/ — MedHub, a privately held medical device company focused on improving and simplifying cardiac care by replacing risky and costly invasive procedures with AI image-based tools, today announced that it has successfully secured $1 million bringing the total sum raised to $4.2 million. The round was led by […]

MediLynx Cardiac Monitoring Partners with National Heart, Lung and Blood Institute & National Institutes of Health on Study of Efficacy of Mobile Cardiac Monitoring for Patients

PLANO, Texas, Feb. 8, 2022 /PRNewswire/ — MediLynx Cardiac Monitoring, LLC (dba MediLynx Arrhythmia Diagnostics™), a national remote monitoring provider and technology leader in deep learning artificial intelligence, today announced a groundbreaking partnership with the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH)-funded Cardiothoracic Surgical Trials Network (CTSN) to participate […]

Leqvio® Therapy to Lower Cholesterol Approved by FDA, IVX Health Now Accepting New Leqvio Patients

NASHVILLE, Tenn., Feb. 8, 2022 /PRNewswire/ — IVX Health, a national provider of infusion and injection therapy for patients with complex chronic conditions, announced today the expansion of its injection formulary with the addition of Leqvio® (inclisiran), a new FDA-approved therapy by Novartis Pharmaceuticals Corporation indicated for the treatment of adult patients with clinical atherosclerotic cardiovascular disease (ASCVD) […]

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

THOUSAND OAKS, Calif., Feb. 7, 2022 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2021 versus comparable periods in 2020. Key results include: For the fourth quarter, total revenues increased 3% to $6.8 billion in comparison to the fourth quarter of 2020, driven by increased Other Revenue […]

CereVasc Receives FDA IDE Approval to Begin Initial Clinical Study of the eShunt® System for Patients with Normal Pressure Hydrocephalus

BOSTON, Feb. 8, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt System in patients […]