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breakthrough device

FDA proposes updates to Breakthrough Devices Program guidance

October 26, 2022 By MassDevice Contributors Network

Emergo by UL The U.S. Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance.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 Specifically, the draft guidance clarifies the considerations […]

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: breakthrough device, Emergo by UL, FDA

Medtech gets behind breakthrough device law for seniors

June 24, 2021 By Nancy Crotti

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 […]

Filed Under: Medical Device Manufacturers Assn. (MDMA), Medicare Tagged With: breakthrough device, Centers for Medicare and Medicaid Services (CMS), FDA, MDMA

CMS delays Medicare payments for breakthrough devices until December

May 17, 2021 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Medical Device Manufacturers Assn. (MDMA), Medicare, Regulatory/Compliance Tagged With: AdvaMed, breakthrough device, Centers for Medicare and Medicaid Services (CMS), FDA, Medical Device Manufacturers Association

Medicare to cover breakthrough devices

January 13, 2021 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Medicare, Regulatory/Compliance Tagged With: AdvaMed, breakthrough device, Centers for Medicare and Medicaid Services (CMS), FDA

Vectorious’ in-heart microcomputer wins FDA breakthrough nod

November 30, 2020 By Nancy Crotti

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, Patient Monitoring, Regulatory/Compliance Tagged With: breakthrough device, FDA, Vectorious Medical Technologies

CMS agrees to cover ‘breakthrough’ medical devices

August 31, 2020 By Nancy Crotti

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. […]

Filed Under: Featured, Food & Drug Administration (FDA), Medicare, Regulatory/Compliance Tagged With: AdvaMed, breakthrough device, Centers for Medicare and Medicaid Services (CMS), Edwards Lifesciences, FDA, Impulse Dynamics, Medtronic, U.S. Department of Health and Human Services

Laminate Medical lands FDA breakthrough nod for dialysis device

June 8, 2020 By Nancy Crotti

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 […]

Filed Under: Dialysis, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: breakthrough device, Dialysis, FDA, Laminate Medical Technologies

Tusker Medical’s pediatric ear tubes land breakthrough device designation

November 26, 2019 By Nancy Crotti

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 […]

Filed Under: Bioelectronic Medicine, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT), Pediatrics Tagged With: breakthrough device, FDA, Tusker Medical

Merit Medical lands breakthrough designation for dialysis stent graft system

November 25, 2019 By Nancy Crotti

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 […]

Filed Under: Dialysis, Featured, Vascular Tagged With: breakthrough device, FDA, Medtronic, Merit Medical Systems

FDA grants breakthrough device status to MediBeacon

October 25, 2018 By Heather Thompson

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 […]

Filed Under: Blog Tagged With: 21st Century Cures Act, breakthrough device, FDA, MediBeacon Inc

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