Emergo by UL The U.S. Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance. Once finalized, the guidance document updates would expand the Breakthrough Devices Program’s scope to include devices that will improve accessibility and promote health equity. Specifically, the draft guidance clarifies the considerations […]
breakthrough device
Medtech gets behind breakthrough device law for seniors
Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation. Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that […]
CMS delays Medicare payments for breakthrough devices until December
Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years. Immediately […]
Medicare to cover breakthrough devices
FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS). The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices […]
Vectorious’ in-heart microcomputer wins FDA breakthrough nod
Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s left atrial pressure (LAP) monitoring device. The V-LAP system is the first digital, wireless, battery-free device that can communicate from deep within the body using high-resolution waveform morphology, according to the Tel Aviv-based startup. Because the pressure of the […]
CMS agrees to cover ‘breakthrough’ medical devices
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. […]
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 […]
