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Hannah Daniel

Reporter

Hannah joined Medtech Insight from HBW Insight in August 2022 and reports on cybersecurity, patent law and other facets of medical device regulation. Hannah is passionate about the intersection of science and communication and holds a bachelor’s degree in biology from Carnegie Mellon University.

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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.

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Postmarket Surveillance Continues To Challenge AI/ML Device Regulators

Postmarket surveillance of AI/ML is a continuing issue for regulation, DHCoE acting assistant director MiRa Jacobs says.

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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.

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Digital Health Center Of Excellence Publishes Policy FAQs

The DHCoE’s new page provides a one-stop-shop for frequently asked digital health policy questions.

Digital Health FDA

Federal Court Rejects Motion To Dismiss Case In Genomics Patent Infringement Suit

Parse Biosciences’ motion to dismiss a patent infringement case has been rejected by a US District Court.

Legal Issues Intellectual Property

AdvaMed Proposes Comprehensive Strategy for CMS To Encourage Access to AI and Software

AdvaMed released a report on tactics CMS could use to improve coverage for AI and software.

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