Hannah Daniel
Reporter
Latest From Hannah Daniel
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.
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.
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.
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.
PTAB Affirms Previous Decision In Favor Of Apple In Masimo Patent Case
A new decision from the PTAB upholds prior rulings rejecting four of Masimo’s appeals and reverses a decision on one.
CMS Promises Actions To Support TCET Pathway
CMS has released a list of actions and guidance documents it plans to take to support the TCET pathway.