Despite Unknowns, Companies Bet On Transcatheter Mitral Valve Repair

Amid the success of transcatheter aortic valve replacement (TAVR), strategic acquisitions of transcatheter mitral valve replacement (TMVR) companies and the success of mitral valve repair device MitraClip, a group of companies are developing a number of minimally invasive options to repair mitral valves. Whether minimally invasive repair, replacement, or some combination will emerge as the best option for patients with mitral regurgitation remains unclear, and insiders say this road will be rockier than it was for TAVR.

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News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.