Author: Ken Dropiewski

First Patients in the World Treated with Impella RP Flex with SmartAssist

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the first three patients in the world have been treated with Impella RP Flex with SmartAssist, Abiomed’s newest heart pump for patients experiencing right heart failure. All three patients have now been successfully weaned off Impella support and two have already returned home with their […]

Medtronic completes enrollment in pivotal trial evaluating first-of-its-kind pulsed field ablation catheter for patients with atrial fibrillation

SPHERE Per-AF will determine the safety and effectiveness of the Sphere-9 cardiac ablation and mapping catheter with the Affera mapping and navigation system DUBLIN, Dec. 5, 2022 /PRNewswire/ — Medtronic (NYSE:MDT) today announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, a U.S. Food and Drug Administration (FDA) […]

Mindray Introduces New Wearable Patient Monitoring System, Refining Clinician’s Workflow to Track Patient Conditions

SHENZHEN, China–(BUSINESS WIRE)–Mindray (SZSE: 300760), a global leader in providing advanced medical device solutions, today launches the mWear™ system, an all-new wearable patient monitoring solution that enables an efficient workflow to continually monitor patient conditions and deliver patient-centric care. With the increased shortages of beds and staff in today’s hospitals, […]

‘Heart failure is no longer Life failure’ as JB Pharma decreases price of critical Heart Failure medicine AZMARDA (Sacubitril-Valsartan®) by nearly 50%

8 to 12 million people suffer from Heart failure in the country and only a fraction can afford treatment Azmarda (Saccubutril-Valsartan®), 50 mg will now be available at INR 39.6 per tablet as compared to INR 78 per tablet Move to increase affordability and accessibility for Heart failure patients across […]

Imagen Technologies Announces FDA Clearance of Aorta-CAD

New AI device expands Diagnostics as a Service platform capabilities. NEW YORK , Dec. 5, 2022 /PRNewswire/ — Imagen Technologies, Inc. announced the U.S. Food and Drug Administration’s 510(k) clearance of the computer-assisted detection (CADe) device Aorta-CAD. This new, FDA cleared device is designed to assist physicians at detecting findings on chest X-rays that […]

Rhythm Management Group Announces Acquisition of Equis Consulting Group

Acquisition creates one of the largest remote cardiac monitoring service providers in the nation. ROCKVILLE, Md., Dec. 5, 2022 /PRNewswire/ — Rhythm Management Group (Rhythm) has announced the acquisition of Equis Consulting Group (Equis), an Indiana-based provider of clinical and consultative remote monitoring and management services. The acquisition, which officially closed on September 30, forms the largest full-service remote […]

Nasdaq Grants Windtree Therapeutics 180-day Extension to Regain Compliance

WARRINGTON, Pa., Dec. 05, 2022 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for cardiovascular disorders, today announced that the NASDAQ Stock Market (“Nasdaq”) has granted Windtree an additional 180 days to regain compliance with Nasdaq’s $1.00 […]

Acticor Biotech Receives European Medicines Agency (EMA) Endorsement on Key Parameters of ACTISAVE, Its Pivotal Phase II/III Study for Registration in Stroke

Approval of ACTISAVE design by the EMA to support a potential future marketing authorization application (MAA) for glenzocimab in Stroke Validation du choix d’un double critère d’évaluation principal : – Échelle de Rankin modifiée (mRS)1 – Échec (versus succès) défini par un handicap grave ou le décès, soit un score mRS 4-6 […]

Sirolimus Coated Balloon in BTK Treatment makes a bold presence at VEITH 2022 – Lights up NY Times Square, NASDAQ

TAMPA, Fla., Dec. 2, 2022 /PRNewswire/ — VEITH 2022 witnessed a surge of supporting clinical data for Sirolimus Coated Balloon in the treatment of Below-the-Knee (BTK) disease. Concept Medical Inc. hosted a lunch symposium titled ‘Sirolimus Coated Balloon in PAD Treatment: Choice of The Future’ which explored the utility of Sirolimus Coated Balloon treatment […]

Acutus Medical Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

CARLSBAD, Calif., Dec. 01, 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, granted equity awards on December 1, 2022 that were approved by the Compensation Committee of its Board of […]