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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 digital therapeutics community has identified unique revenue streams, friendly regulations and development opportunities that have them feeling optimistic.

DTA Digital Health

News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

News We're Watching Approvals

DTX Companies Find New Niche As Complement To Standard Of Care

Digital therapeutics aren’t going away anytime soon, but they are positioning themselves as a complement to traditional therapies.

Digital Health DTA

What’s New In Digital Therapeutics? Investment Strategies, Reimbursement And More From DTA Annual Summit Day 1

The Digital Therapeutics Alliance’s annual summit kicked off in Washington, DC, with a robust panel schedule that included advice on reimbursement strategies, provider access, and lessons learned from past mistakes.

DTA Digital Health

Expert: Which AI Standard Is The Gold Standard?

When looking for a standard for AI development, expert Eric Henry recommends turning to the tried-and-true Standard Delivery Organizations (SDOs).

Artificial Intelligence Regulation

Expert: FDA Missed Opportunity For Software In Remanufacturing Guidance

Device attorney Jason Brooke says that the FDA’s recent guidance document on device remanufacturing represents a “missed opportunity” to discuss software.

Guidance Documents Regulation
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