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Hannah Daniel

Senior 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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The accelerated approval of Rezdiffra, the first drug authorized by the FDA to treat metabolic dysfunction-associated steatohepatitis (MASH), presents a large opportunity for imaging and diagnostic devices.

Regulation Liver & Hepatic

News We’re Watching: Roche Patent Suit, Dental Device Guidance Docs, Edwards Partners With Affluent Med

This week, Roche filed suit against Foresight Diagnostics and Stanford University over patent infringement; the former head of a COVID-19 test company was convicted of securities fraud; and Baxter announced a recall of Life2000 ventilators.

Commercial Regulatory

FDA Addresses Medical Product Misinformation For The Post-COVID World

The FDA’s updated guidance on internet responses to misinformation adds considerations for a post-COVID, social media influencer world. 

Guidance Documents Safety

AI Prostate Cancer Identification Device Increases Mapping Accuracy

A study published in The Journal of Urology found that Avenda Health’s Unfold AI helped doctors identify prostate cancer more accurately.

Artificial Intelligence Commercial

Class I Device For Methadone Dosing Decreases Costs, Save Lives

Sonara Health founder Michael Giles talks take-home methadone treatments, remote patient monitoring and sponsoring legislation to fund opioid treatment programs.

Behavioral Health Digital Health

Amendments To Breakthrough Device Coverage Act Push Bill Out Of House Ways And Means Committee

The amendment introduced to the Ensuring Patient Access to Critical Breakthrough Products Act in the Ways and Means committee markup of helped usher the legislation to a passing vote.

Policy Advisory Committees
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