Approval marks second clinical trial approved by FDA this year for Company’s NK1R+ MSC platform Allogeneic CardiALLO therapy for heart failure to complement autologous cell therapy currently enrolling in Phase III CardiAMP Heart Failure clinical trial SUNNYVALE, Calif.–(BUSINESS WIRE)–BioCardia, Inc. [Nasdaq: BCDA], […]
Author: Ken Dropiewski
Gossamer Bio Announces Seralutinib Meets Primary Endpoint in Phase 2 TORREY Study in PAH
– Primary Endpoint, Change in PVR at Week 24, Met with P-Value of 0.0310 – – Secondary Endpoint, Change in 6MWD, Numerically Favored Seralutinib – – Statistically Significant Improvements Observed in NT-proBNP and ECHO Measures of Cardiac Structure and Function […]
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 […]
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 […]
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 […]
‘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 […]
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 […]
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, […]
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 […]
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 […]