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Bill would require Medicare to cover breakthrough devices for four years

Dive Brief: House lawmakers have introduced a bipartisan bill that would require Medicare to temporarily cover breakthrough medical devices for four years while the Centers for Medicare and Medicaid Services would be required to make a permanent coverage determination. The bill’s goal is to provide Medicare beneficiaries with faster access to Food and Drug Administration-approved breakthrough devices by removing “unnecessary barriers” that prevent seni...
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FDA qualifies tool for predicting temperature rise when orthopedic implants enter MRI scanners

Dive Brief: The U.S. Food and Drug Administration has qualified a tool made by NEVA Electromagnetics to predict the temperature rise when patients with certain orthopedic implants undergo magnetic resonance imaging (MRI). By qualifying the technology under its Medical Device Development Tools (MDDT) program, the FDA has cleared sponsors to use the simulation in the development and evaluation of metallic femoral nails. The tool can help sponsors ident...
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Safety of fixed palatal expanders probed by FDA amid patient lawsuits

Dive Brief: The U.S. Food and Drug Administration is evaluating concerns about the safety of unauthorized fixed palatal expanders that have been used to treat conditions including sleep apnea. Palatal expanders are used to widen the roof of the mouth to make room for crowded teeth in children and adolescents. However, when the devices are used in adults, whose upper jaw bones are fused, it can result in tooth loss, bone erosion, and other serious co...
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FDA drafts guidance to ease path to updates for AI-enabled devices

Dive Brief: Medtech companies will be able to more easily update devices with an artificial intelligence or machine learning component under a new regulatory framework being developed by the Food and Drug Administration. On Thursday, the agency shared a draft guidance for “predetermined change control plans,” essentially a set of modifications that device developers can include as part of a marketing submission. Typically, medical algorithms are “loc...
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ICU Medical challenges GE HealthCare for Medtronic units valued at $8B: report

Dive Brief: Intravenous therapy specialist ICU Medical has joined GE HealthCare on the list of companies interested in buying Medtronic’s patient monitoring and respiratory interventions businesses, according to Reuters. Medtronic wants to offload the two units to focus on faster-growing parts of its business and is talking to potential buyers while preparing to spin off the divisions if a deal fails to materialize. The company is seeking $8 billion...
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