Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.
The U.S. FDA has had its sights on artificial intelligence (AI) for some time, but an upcoming advisory hearing will review questions such as the regulatory status of a generative AI (GenAI) algorithm. This is just one of several AI-related dilemmas facing the agency in the next few years.
The U.S. FDA’s new draft guidance for the voluntary incorporation of patient preference information (PPI) in device development says that PPI would be included in product labels for cleared or approved medical devices.
The EU’s still-new regulations for medical devices and in vitro diagnostics are often seen as drivers of current or impending shortages of these products, but Oliver Eikenberg of regulatory consultancy Pure Global is unimpressed by such claims. Eikenberg said much of the drag on the EU system is engendered by device makers that are failing to get their regulatory affairs in order – a problem neither Brussels nor the notified bodies can fix.
The FDA announced a class I recall of Evair compressors by Chicago-based GE Healthcare due to elevated levels of formaldehyde when the devices are used with specific models of Carescape or Engstron ventilators.
Medicare coverage of digital mental health therapies has traditionally been lacking, but the final Medicare physician fee schedule for 2025 added three new codes to deal with the coverage gap.
While the inpatient and outpatient final rules for 2025 are baked into the U.S. Medicare payment system, there are indications that Congress will consider legislation that would flatten rates across sites of service.
The U.S. FDA reported a class I recall of tracheostomy tube kits by Minneapolis-based Smiths Medical Inc., because of the risk of separation of the tube’s pilot balloon and inflation line.
The U.S. Medicare outpatient final rule affirms several new devices for the new technology pass-through program, but one of the more significant findings is that CMS will use separate payment mechanisms for two renal nerve denervation devices, following the blueprint the agency employed for this question in the inpatient final rule.
The first year of data from the TRISCEND II study of the Evoque tricuspid valve by Edwards Lifesciences Corp. confirm the notion that reduced regurgitation has a big impact on patient well-being. While one-year data support the device’s safety, cardiovascular mortality at one year does not seem to decisively favor the device over medical management.
