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], a developer of cellular and cell-derived therapeutics for the treatment […]
Coronary/Structural Heart
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 – – Consistently Positive Results Seen Across Pre-Specified Sub-Groups, Including […]
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 […]
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 […]
Cordio Medical HearO™ Voice Signature Technology Demonstrates Superior Standard of Care for Heart Failure Patients
Community Study successfully predicted heart failure events, increasing opportunities for preventative care NEW YORK, Nov. 29, 2022 /PRNewswire/ — Cordio Medical, a market-leading medical speech processing platform, shared key findings in the HearO™Community Study: Remote Speech Analysis of Hospitalized Patients with Acute Decompensated Heart Failure that assessed remote speech analysis through the Cordio HearO™application. Dr. William Abraham, […]
Evkeeza® (evinacumab-dgnb) sBLA for Children with Ultra-rare Inherited Form of High Cholesterol Accepted for FDA Priority Review
If approved, Evkeeza would be the first and only treatment of its kind to help children as young as 5 years old control dangerously high levels of LDL cholesterol caused by homozygous familial hypercholesterolemia TARRYTOWN, N.Y., Nov. 30, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has […]
Medtronic’s Next-Gen Evolut™ FX TAVR System Shows Significant Improvement in Commissure Alignment in Real World Setting
London Valves 2022: Latest Transcatheter Aortic Valve Replacement Data for Treatment of Aortic Stenosis and Prosthetic Aortic Valve Degeneration Medtronic’s newest generation self-expanding, transcatheter aortic valve replacement (TAVR) system, Evolut™ FX, significantly improved commissure alignment during TAVR procedures compared to earlier generation Evolut systems. A late breaker presentation at PCR […]
UAB Cardiogenomics Clinic and Allelica to perform polygenic risk score clinical implementation study
The Cardiogenomics Clinic at the University of Alabama at Birmingham and Allelica are partnering to perform a clinical implementation study to assess how polygenic risk score integration changes clinical management and health outcomes in a US health system. NEW YORK, Nov. 29, 2022 /PRNewswire/ — The UAB Cardiogenomics Clinic, led by Dr. Pankaj Arora, is […]
Neovasc Announces Progress on COSIRA-II Clinical Trial
VANCOUVER and MINNEAPOLIS, Nov. 28, 2022 (GLOBE NEWSWIRE) — via NewMediaWire – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced an update on the COSIRA-II Clinical Trial (“Trial”) status. COSIRA-II is the U.S. Investigational Device Exemption (“IDE”) pivotal clinical trial the Company is executing for the Neovasc Reducer™ (“Reducer”) towards an approval […]
