1. Medtech Insight
  2. >>Digital Technologies

Medtech Connect 16: AI For Cross Border Regulation

 
• By Hannah Daniel

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.

Medtech Connect
• Source: Citeline/Shutterstock

Further Reading

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

Q-Sub Guidance Needs Clarity On Informal Meetings And Timelines, Say Commenters

Medtech Multinationals Up Pace Of Localization Strategies In China

‘Blah-Blah’ May Subside, But Harnessing AI Ethically, Impactfully Is Key For Medtech In 2024

Further Listening

This and all our other podcasts are available on the Citeline channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.

More from Digital Technologies

US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

23andMe Files For Bankruptcy, Raising Fresh Concerns Over Fate Of Genetic Data

23andMe has filed for Chapter 11 bankruptcy and announced the resignation of founder and CEO Anne Wojcicki. Privacy concerns surrounding the sale of its extensive genetic database remain after a 2023 data breach exposed data from some 7 million users. Experts warn that bankruptcy proceedings could lead to consumer data being sold, raising questions about legal protections and consumer rights.

European Medicine Agency’s CHMP Qualifies First AI Tool For Use In Clinical Trials

 
• By Natasha Barrow

With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.

Barcelona’s S2 Xpeed Accelerates Hardware-Based Medtech Start-Ups From Prototype To Market

 
• By Marion Webb

Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.

More from Market Access

Prostate Cancer Research Urges UK To Implement Screening Program Without Delay

 
• By Natasha Barrow

Implementing a reflex test alongside traditional prostate cancer screening is cost-effective for high-risk groups, claims Prostate Cancer Research. Oxford BioDynamics sheds light on UK market conditions influencing the adoption of its reflex test, EpiSwitch PSE.

Philips Partners With Three Health Insurance Providers To Remotely Monitor High-Risk Pregnancies

 
• By Natasha Barrow

Several counties in the US state of Georgia are maternity care “deserts.” Remote monitoring of high-risk pregnancies with maternal hypertension and diabetes could help improve the state’s high rate of maternal mortality, according to leading health service provider Philips.

Medtronic Widens Parkinson’s aDBS Opportunity With Key US Approvals

 
• By Natasha Barrow

Medtronic’s US FDA approval for BrainSense aDBS and BrainSense EI software features of the Percept neurostimulator device has quickly followed CE marking in January.