Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 26 August to Friday 30 August. 

FDA approval—MID-C (ApiFix)
ApiFix has received FDA approval, via a Humanitarian Device Exemption (HDE), to market the minimally invasive deformity correction system for the treatment of progressive adolescent idiopathic scoliosis. A press release reports that ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction while retaining spine flexibility, all via a less invasive surgical procedure compared to spinal fusion.

FDA approval—Biobeat patch and watch for measuring blood pressure
The FDA has granted a 510K clearance for Biobeat’s patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. According to press release, Biobeat’s products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.

FDA Breakthrough Device Designation—MagicTouch AVF (Concept Medical)
Concept Medical has been granted Breakthrough Device Designation from the FDA for the MagicTouch AVF, sirolimus-coated, balloon catheter for the management of stenotic lesions of arteriovenous fistulae or arteriovenous graft in haemodialysis treatment of renal failure.