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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.

Latest From Hannah Daniel

Medtech Connect 16: AI For Cross Border Regulation

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.

Digital Health Manufacturing

News We’re Watching: Nipro Medical Invests $397.8M In First US Facility; Baxter, Hamilton Ventilator Recalls; FDA Warnings; And More

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

News We're Watching Approvals

FDA Supports DMCA Exemption, Including For Cybersecurity

A letter from Suzanne Schwartz affirms that the FDA approves the extension of a copyright-law exemption that lets third parties access software in medical devices for repair or maintenance, but not for modifications that could affect device safety.

Legal Issues FDA

Apple Watches Don’t Fall Under Limited Exclusion Order For ECG Tech

US Customs and Border Protection ruled that Apple’s ECG technology doesn’t infringe on AliveCor’s patent and doesn’t have to comply with a previous import ban.

Regulation Intellectual Property

Fatty Liver Disease Drug Approval Opens New Patient Population In Imaging Market

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
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