Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning. Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date a breakthrough device’s FDA market authorization would begin and continue for 4 years. […]
breakthrough device
Laminate Medical lands FDA breakthrough nod for dialysis device
Laminate Medical Technologies today announced it has won FDA breakthrough device designation for its VasQ external support for patients in need of an arteriovenous fistula (AVF) for hemodialysis. Tel Aviv, Israel–based Laminate’s VasQ device is a nitinol external support placed around the artery and vein at the creation site. It is designed to optimize the […]
Tusker Medical’s pediatric ear tubes land breakthrough device designation
The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the […]
Merit Medical lands breakthrough designation for dialysis stent graft system
Merit Medical (NSDQ:MMSI) announced last week that it has been granted FDA breakthrough device designation for its Wrapsody endovascular stent graft system. Wrapsody is a flexible, self-expanding endoprosthesis designed for hemodialysis patients. Merit said it will seek indication to treat stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up […]
FDA grants breakthrough device status to MediBeacon
MediBeacon (St. Louis) recently announced that it has won FDA breakthrough device designation for its Transdermal GFR Measurement System (TGFR). TGFR is one of several products granted breakthrough status, FDA’s expedited path outlined in the 21st Century Cures Act. The product measures glomerular filtration rates (GFRs) in patients with impaired or normal renal function. TGFR is considered […]
