The US Medicare agency issued on 12 January its final MCIT rule allowing instant reimbursement for FDA breakthrough devices – unless the incoming Biden administration blocks it.
The US Centers for Medicare and Medicaid Services on 12 January approved a final reimbursement regulation, the Medicare Coverage of Innovative Technology rule, which the medtech industry has been pushing the agency to adopt for the last several years. However, there is a worry the new rule – a product of the Trump administration – could be temporarily or permanently blocked by the incoming Biden administration.
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While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.
GE HealthCare anticipates most of the $0.85 EPS tariff impact will play out in the second half of 2025. Jay Saccaro, vice president and CFO, said the tariff-related burden is minimal in Q1 at about $10 million, rising to nearly $100 million in Q2 and then spiking to around $200 million each in Q3 and Q4.
Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.
