CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices
fiercehealthcare - The Trump administration unveiled a new program to speed up Medicare coverage for breakthrough devices, touting that the new pathway cuts red tape for medical device companies to gain reimbursement. CMS said it will pause the existing TCET pathway.
AI Summary: CMS and the Food and Drug Administration launched a coordinated program to accelerate Medicare coverage for breakthrough medical devices, aiming to shorten the gap between regulatory approval and patient access. The initiative aligns agency review processes, defines eligibility, and seeks faster coverage decisions while maintaining safety and evidentiary standards.
- New imaging and monitoring devices promise faster, remote patient care. (3)
- On scene: agencies align to speed device approvals and coverage. (6)
New imaging and monitoring devices promise faster, remote patient care.
On scene: agencies align to speed device approvals and coverage.
FDA approves 1st 2-drug HIV treatment
Ella Jeffries / beckershospitalreview - The FDA has approved Merck’s once-daily, two-drug regimen for adults with virologically suppressed HIV-1. The treatment combines 100 mg doravirine and 0.25 mg islatravir and is indicated for patients with no history of virologic treatment failure and no k…
AI Summary: The FDA has approved Merck’s once‑daily two‑drug antiretroviral regimen, marking a notable market entrant poised to compete with established single‑pill therapies. Regulators cleared the novel combination on efficacy and safety data, setting up potential shifts in prescribing, pricing and competition — and giving Gilead something new to grumble about.