Biocardia Inc. received FDA breakthrough device designation for its Cardiamp cell therapy system for treatment of heart failure. The good news provided a welcome 27% boost to the share price (NASDAQ:BCDA), lifting it from $1.57 at Wednesday’s close to $2.00 by the market’s close Thursday. Extended timelines for trials associated with the pandemic have hammered the company, which has seen its stock price fall more than 60% in the last two years.
Innovheart srl has landed more than $55 million to continue clinical trials of its transcatheter mitral valve replacement (TMVR) system for the treatment of mitral valve disease. The series C equity round was led by Grand Pharmaceutical Group Ltd. (Grand Pharma), together with existing investors Genextra, Panakes Partners and Indaco Venture Partners.
The U.S. Preventive Services Task Force (USPSTF) has once again broached the question of whether screening for atrial fibrillation (AF) in asymptomatic patients is a worthwhile exercise in public health, and once again the answer is “we don’t know.”
The FDA announced a class I recall of the Medtronic Hawk One directional atherectomy catheter system due to more than 160 reports of problems with the device’s guidewire. The catheter tip could break or separate when the guidewire prolapses, a problem that is associated with 55 injuries and no deaths, but the recall affects more than 95,000 units.
PARIS – Robocath SAS has concluded an initial clinical study in Europe to demonstrate the safety and efficacy of robotic coronary angioplasty performed using its R-One platform. Sixty-two patients from six European hospitals participated in the R-Evolution clinical study. The study was aimed at assessing the safety and efficacy of the R-One robotic assistance platform.
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