Edwards Lifesciences Corp. received U.S. FDA approval for its Sapien M3 mitral valve replacement system, making it the first transcatheter therapy utilizing a transseptal approach to be indicated for treatment of mitral regurgitation (MR). The Sapien M3 transcatheter mitral valve replacement system is indicated for the treatment of patients with symptomatic moderate-to-severe or severe MR or symptomatic mitral valve dysfunction who are deemed unsuitable for surgery or TEER by a multidisciplinary heart team.

Bayosthiti AI Pvt Ltd. aims to make RNA sequencing and AI-based preventive health care affordable and accessible for the Indian market, leveraging intellectual property from its parent company, Biostate AI Inc.

Cytokinetics Inc. scored U.S. FDA marketing clearance Dec. 19 for Myqorzo (aficamten) 5-mg, 10-mg, 15-mg, and 20-mg tablets to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Shares of the South San Francisco-based firm rose 4.6%, or $2.88, on Dec. 22 to close at $65.60.