Featured Stories
Digital Health Review Founder Blair Hirst Focuses On Health Equity
As a biomedical engineer, Blair Hirst saw how health technology could help patients – and how some communities were slowest to benefit. As founder of the Digital Health Review, she now works to improve equity in health care spaces.
Notified Body Numbers Continue To Shoot Upwards As Turkey Gains Third Certification Body
The designations of notified bodies are coming fast and furious, with four announcements in a month.
Remanufacturing Guidance Adds Info On Premarket Requirements For Remanufacturers
After clarifying what a remanufactured device is in its 2021 draft guidance, FDA’s final guidance adds information about regulatory requirements for companies whose devices qualify as remanufactured.
News We’re Watching: UK Plans Digital Health Guidance, FDA Warns Against Getinge/Marquet Cardiac Devices
This week, MHRA and NICE released results from their first survey of potential digital health tool users; the FDA warned against using Getinge/Marquet cardiac devices; and Illumina announced plans to hand its Grail spin-off to existing shareholders.
Spotlight On Conferences
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
‘Biggest Transformation In The History Of Medicine’: Oncologist And Cardiologist Talk AI-Enabled Health Care
A More Cautious Approach To AI, And Other Policy And Regulation Trends From HIMSS 24
Creating Standards For Responsible AI In Health Care
Imagining Cybersecurity As An Ecosystem: From Regulations To Resiliency
Latest News
Medtech Insight Podcasts
This Episode:
Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia DiagnosticsListen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.
More PodcastsData Trackers
Global Device Regulation
US FDA Clearance For Masimo’s Stork Delivers OTC Baby Monitoring Tech Competition
Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.
Medtech Connect Episode 15: Digital Trust
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.
Latest Designation Of Italian Notified Body Brings EU Total Under Medical Device Regulation To 47
EU announces the third designation under the MDR in a month.
A Collective Vision For UK Industry: 10-Point Medtech Manifesto
With much at stake as the UK closes in on national elections, healthtech manufacturers have issued their own manifesto setting out how political leaders can be winners for patients and industry.
Digital Health
Medtech Connect Episode 15: Digital Trust
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.
GlucoTrack’s CEO Wants To ‘Keep Pushing The Boundaries’ With Implantable CGM
CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and develop new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.
US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation
Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.
Apple Watch Feature Qualified As FDA Device Development Tool
The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.
Interviews
Digital Health Review Founder Blair Hirst Focuses On Health Equity
As a biomedical engineer, Blair Hirst saw how health technology could help patients – and how some communities were slowest to benefit. As founder of the Digital Health Review, she now works to improve equity in health care spaces.
Medtech Connect Episode 15: Digital Trust
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.
GlucoTrack’s CEO Wants To ‘Keep Pushing The Boundaries’ With Implantable CGM
CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and develop new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.
To Be (a device) Or Not To Be. That’s The Legal Question
Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.
Podcasts
Medtech Connect Episode 15: Digital Trust
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.
Digital Health Roundup: US FDA’s ‘Idea Lab’; Philips’ Roy Jakobs On AI Draft Framework; Apple Watch
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and a new feature on the Apple Watch to help people with Parkinson's disease overcome freezing gait.
Medtech Connect 14: Live From HIMSS
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.
Digital Health Roundup: Impact Of EU’s AI Act On Device Makers; Verily's Andrew Trister’s Vision For Personal AI Agent
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Verily’s CMO and CSO, Andrew Trister at ViVE on leveraging AI for precision health and a DHIS West conference panel discussion on use cases of generative AI. Elizabeth Orr discusses the impact on the newly adopted EU AI Act on device makers and concerns raised by industry members.
Recent Stories
US FDA Clearance For Masimo’s Stork Delivers OTC Baby Monitoring Tech Competition
Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.
Medtech Connect Episode 15: Digital Trust
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.
GlucoTrack’s CEO Wants To ‘Keep Pushing The Boundaries’ With Implantable CGM
CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and develop new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.
Latest Designation Of Italian Notified Body Brings EU Total Under Medical Device Regulation To 47
EU announces the third designation under the MDR in a month.
A Collective Vision For UK Industry: 10-Point Medtech Manifesto
With much at stake as the UK closes in on national elections, healthtech manufacturers have issued their own manifesto setting out how political leaders can be winners for patients and industry.
Warning Letters And Close-Outs – April 2024
The US Food and Drug Administration released eight warning letters and one close-out last month. Big names caught in the net included Beckman Coulter, Royal Philips and Cardinal Health.
To Be (a device) Or Not To Be. That’s The Legal Question
Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.
US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation
Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.
Netherlands Pilots New Scientific Advice Service For Clinical Trials
The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials, which is for now free of charge.
MHRA Sets Out Summer Schedule Of Medtech Regulatory Milestones
UK devices regulator signals near-term progress on PMS statutory instrument, policy statement on international recognition and input into IMDRF project to update global diagnostics guidance.
Apple Watch Feature Qualified As FDA Device Development Tool
The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.
Expert Proposes AI Device Reimbursement Model ‘Like Netflix’
Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.