Latest From Hannah Daniel
NWW: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients
This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.
Postmarket surveillance of AI/ML is a continuing issue for regulation, DHCoE acting assistant director MiRa Jacobs says.
New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears
With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers. Medtech Insight’s round-up of four device-specific documents is below.
The DHCoE’s new page provides a one-stop-shop for frequently asked digital health policy questions.
Parse Biosciences’ motion to dismiss a patent infringement case has been rejected by a US District Court.
AdvaMed released a report on tactics CMS could use to improve coverage for AI and software.