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...
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.
Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
