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 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.

Acutus Medical Inc. provided highlights of a corporate restructuring along with preliminary unaudited revenues for the fourth quarter and year ended Dec. 31, 2021. The company “will prioritize maximizing console utilization and procedure volume growth in targeted geographic regions as well as a more focused scope of product development initiatives.” The restructuring will include the layoff of more than 50 staff members and reduction of manufacturing costs designed to produce annualized operating expense savings of $23 million to $25 million in 2022.

Peijia Medical Ltd. has acquired exclusive rights to Jenavalve Technology Inc.’s transcatheter aortic valve replacement (TAVR) products for the treatment of aortic regurgitation (AR) and aortic stenosis (AS). Suzhou, China-based Peijia is now able to develop, manufacture, and commercialize the TAVR products in Greater China.

Abbott Laboratories received FDA 510(k) clearance for the Ensite X EP system with Ensite omnipolar technology, the company’s cardiac mapping platform. The system, which is used to identify and treat abnormal heart rhythms such as atrial fibrillation, produces detailed three-dimensional maps of the heart to guide physicians performing ablation procedures.

A panel of leaders in women’s health at the 2022 edition of the J.P. Morgan Healthcare Conference addressed the challenges and benefits of digital health and new apps in enabling women to be the “chief medical officers” of their families’ health and to take the necessary steps to improve their own. The panel included moderator Lynne Chou O’Keefe, founder and managing partner of Define Ventures; Apple Inc.’s Vice President of Health Sumbul Ahmad Desai; Veronica Gillispie-Bell, assistant professor, Ochsner Health System; Found CEO Sarah Jones Simmer; Michelle Williams, dean of faculty at the Harvard T.H. Chan School of Public Health; and Tia Inc. CEO and co-founder Carolyn Witte.

Two med-tech giants GE Healthcare Ltd. and Boston Scientific Corp. are teaming up to expand cardiac care in Southeast Asia. GE Healthcare and Boston Scientific reported plans to collaborate on an end-to-end cardiac care solution offered to cardiac care centers in Southeast Asia. The suite of care offered ranges from diagnostic to percutaneous coronary intervention.