US firm 4C Medical Technologies is developing a unique solution to mitral regurgitation that sits outside the valve and takes advantage of the native valve's remaining function while preventing mitral regurgitation. The Minnesota-based start-up is currently funded by angel investors and "friends and family," but expects to raise a $15m Series B round in early 2018.
4C Medical Technologies is addressing the unique problems of dysfunctional mitral valves with a device that sits in the atrium rather than within the valve annulus itself, which will hopefully allow it to last longer and avoid many of the complications faced by other minimally invasive mitral valve replacement technologies.
The mitral valve is more challenging to address than the aortic valve currently addressed by a variety of transcatheter devices...
Spain has one of the highest incarceration rates in Europe, with 160 individuals imprisoned per 100,000 residents. In 2020, 43,494 people were incarcerated in facilities not managed by regional health authorities — essentially all regions except Catalonia, the Basque Country, and Navarra.
The Acton, MA-based tubeless insulin pump specialist expands its indication for the Omnipod 5 AID system beyond type 1 diabetes as FDA authorization for type 2 comes sooner than Wall Street expected. Analysts expect clearances of rival systems from Tandem Diabetes Care and Medtronic in 2025, but believe Insulet is well-positioned to compete.
Two years after the EU adopted the original common specifications for certain products under the IVD Regulation, the commission has added new products and updated its requirements.
Hello Heart has introduced a symptom tracking feature in its app, allowing users to log feelings of dizziness or shortness of breath in conjunction with blood pressure readings. The enhancement will help all users to monitor cardiovascular risks, but women in particular could benefit, the company suggests.
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.
