Hannah Daniel
Senior Reporter
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Latest From Hannah Daniel
DHCoE AI Lifecycle Management Plan To Serve As ‘Playbook’ For Standards
A new AI lifecycle management framework from the US FDA’s Digital Health Center of Excellence introduces considerations for the seven steps of the AI lifecycle.
Digital Health Roundup: Brain Talk On Seizures, Alzheimer's, Stress, Anxiety; Medtronic's OR Report; Health Care AI; UK Guidances
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room.
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.
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.
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.
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.