The FDA granted breakthrough device designation to Volumetrix LLC for its NIVAHF monitoring system for heart failure. The device is the first application of the company’s noninvasive venous waveform analysis (NIVA) technology, which captures and analyzes vital information about blood volume to assess patient status.
Medtronic plc is ceasing global sales and distribution of its Heartware ventricular assist device (HVAD) due to safety concerns. The news sent Medtronic shares down about 1% in early morning trading. The Dublin-based company said it made the decision to stop selling the HVAD left ventricular assist device after clinical comparisons found a higher frequency of neurological adverse events, including stroke and mortality, with its heart pump device vs. other circulatory support systems.
Astrazeneca plc followed up its win a year ago in heart failure (HF) with yet another approval for its oral SGLT2 inhibitor, Farxiga (dapagliflozin), now cleared by the FDA to reduce the odds of kidney function decline, failure, cardiovascular death and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression.
The American College of Cardiology (ACC) hopes artificial intelligence (AI) can dramatically increase adoption of its frequently ignored guidelines for cardiovascular care. In three new studies, the ACC will implement Healthreveal's AI to recommend personalized interventions with the goal of preempting adverse cardiovascular events and improving patient outcomes, while increasing physicians’ adherence to guideline-directed medical therapy.
Corvista Health Inc., a subsidiary of Toronto-based Analytics for Life Inc., reported closing on $65 million in series C equity financing, bringing total cash raised for a new cardiac diagnostics device to nearly $100 million. The Corvista system is described as noninvasive, point-of-care diagnostic system for coronary artery and other cardiovascular diseases.
TORONTO – Puzzle Medical Devices Inc. has been granted a U.S. FDA breakthrough device designation for a transcatheter heart pump designed for fragile patients with few minimally invasive options for treating advanced heart failure.
An artificial intelligence (AI) algorithm developed by Geisinger researchers that uses echocardiogram videos predicted all-cause mortality at one year more accurately than three out of four expert cardiologists and other predictors commonly used in clinical practice, a study in Nature Biomedical Engineering demonstrated.
Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic.
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. saw its stock drop 15% on the news that its allogeneic mesenchymal cell therapy, rexlemestrocel-L (Revascor), failed to meet the primary endpoint of a reduction in hospitalizations in its phase III advanced chronic heart failure trial.
PARIS – Fineheart SA has announced the success of a 30-day preclinical trial to evaluate its implantable cardiac output management system (ICOMS) for patients suffering from severe heart failure. The device was well-tolerated with no related adverse events seen during the 30 days.
