CMS does not currently have a national coverage determination process open on ventricular assist devices for heart failure, though the agency may open a new one, an agency official said.
A Medicare advisory panel has concluded that while ventricular assist devices can play a key role in managing end-stage heart failure, there are still considerable holes in the evidence base, particularly for patients who have less advanced disease.
CMS convened the Medicare Evidence Development and Coverage Advisory Committee at its Baltimore headquarters on Nov. 14 to gather independent...
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The US FDA posted three warning letters in July, covering medical supply kits, wearable's and orthopedics.
Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.
The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.
EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.
The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients avoid further testing with CSF or PET scans.
