The US Centers for Medicare and Medicaid Services followed through with a plan to expand its national coverage policy for MRI scans, removing contraindications and clinical-study requirements for patients with pacemakers, implantable cardioverter defibrillators and other cardiac rhythm devices.
Multiple Medicare restrictions remaining for performing MRI scans on patients implanted with cardiac rhythm devices were removed in a new policy issued by the US government April 10.
The US Centers for Medicare and Medicaid Services (CMS) finalized its plan to remove contraindications and coverage-with-evidence-development restrictions on MRI...
The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.
2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.
