Featured Stories
European Parliament Proposes Radical Changes For The Recertification Of Medical Devices
Just as concerns are growing in the sector about how notified bodies will manage simultaneous surges in requests for recertification and legacy devices around 2027/28, the European Parliament has launched a key initiative.
Twin Health Extends AI-Powered Program To Help Healthy People Sustain Weight Loss Without GLP-1
Twin Health extends its whole-body digital twin AI platform to help people who are overweight or obese achieve a healthy weight without the use of medications.
EMA Answers More Questions For Manufacturers of Drug-Device Combos
Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.
News We’re Watching: Panel Backs Guardant Shield, EU Adopts AI Act, Magellan Settles Lead Test Claims
This week, an FDA advisory panel recommended approval of the Guardant Shield blood test for colon and rectal cancers; the EU Council signed off on the world’s first AI law; and the FDA challenged innovators to develop AI/ML technologies to detect gait freezing in individuals with Parkinson’s disease
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
MDIC Benchmark Survey Finds Cybersecurity Maturity Still Lacking Among Device Manufacturers
Device manufacturers still have a low level of cybersecurity maturity, but larger companies seem to be doing better than smaller ones.
Common Specifications For UK High-Risk IVDs Mooted As Part Of Future Core Regulations
Medicines and Healthcare products Regulatory Agency’s four week consultation is targeted at improved safety for certain high-risk in vitro diagnostics.
Telehealth Experts Discuss Access In Health Care Deserts, Overcoming Provider Resistance, Liability Concerns
Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.
Notified Bodies Double Certifications Since 2022
A recent survey by trade group TEAM-NB found that the number of certificates issued under the IVDR and MDR doubled between 2022 and 2023. However, application completeness remained an issue, with notified bodies estimating that a third of applications were less than 25% complete.
Digital Health
Click Targets ‘Best-In-Class Digital Therapy For Chronic Weight Management’ With Better Therapeutics Acquisition
Click will fold Better Therapeutics’ FDA-cleared AspyreRx prescription digital therapeutic into R&D for its own CT-181, which promises to optimize obesity treatment in combination with drugs such as GLP-1s and provide "valuable real-world data insights for providers and payers." Better Therapeutics shuttered its operations in March, signaling continued challenges for digital medicine innovators.
Telehealth Experts Discuss Access In Health Care Deserts, Overcoming Provider Resistance, Liability Concerns
Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.
AI Assisted Ablation Bests Conventional Procedure, Trial Data Shows
A study by French device firm Volta found an AI-guided ablation procedure was more effective in treating patients with atrial fibrillation, especially those whose symptoms had persisted for six months or longer.
Dexcom Announced Launch Of One+ CGM In UK, State Of Type 2 Report
Dexcom launches its highly customizable One+ continuous glucose monitor in the UK as well as a state of type 2 report that suggests 63% of people living with type 2 diabetes have trouble managing their disease.
Interviews
DeepPsy Launches EEG/ECG Analysis For Precision Mental Health Treatment
Swiss-based start-up DeepPsy aims to streamline mental health care using EEG and ECG biomarkers to better match depression patients with treatments. Co-founder Mateo de Bardeci discusses the company’s vision as it launches its in-house medical device as a service in Switzerland.
‘Mental Health, Beyond Medication’: Motif Targets Depression With Minimally Invasive DOT
Motif’s “pea-sized” Digitally programmable Over-brain Therapeutic (DOT) requires 20 minutes to implant and can be activated at home with a wearable to “lift the fog” for people with depression. Motif CEO Jacob Robinson believes data captured by brain-computer interfaces and continuous monitoring will eventually be able to identify key biomarkers that enable psychiatrists to head off mental health crises.
Hospital At Home: Great On Paper, Not In Practice
To avoid a wider health equity gap for home-use devices, companies should make social determinants of health a key consideration in device development, former nurse Amy Hester says.
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.
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
MDIC Benchmark Survey Finds Cybersecurity Maturity Still Lacking Among Device Manufacturers
Device manufacturers still have a low level of cybersecurity maturity, but larger companies seem to be doing better than smaller ones.
Click Targets ‘Best-In-Class Digital Therapy For Chronic Weight Management’ With Better Therapeutics Acquisition
Click will fold Better Therapeutics’ FDA-cleared AspyreRx prescription digital therapeutic into R&D for its own CT-181, which promises to optimize obesity treatment in combination with drugs such as GLP-1s and provide "valuable real-world data insights for providers and payers." Better Therapeutics shuttered its operations in March, signaling continued challenges for digital medicine innovators.
Common Specifications For UK High-Risk IVDs Mooted As Part Of Future Core Regulations
Medicines and Healthcare products Regulatory Agency’s four week consultation is targeted at improved safety for certain high-risk in vitro diagnostics.
Telehealth Experts Discuss Access In Health Care Deserts, Overcoming Provider Resistance, Liability Concerns
Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.
Notified Bodies Double Certifications Since 2022
A recent survey by trade group TEAM-NB found that the number of certificates issued under the IVDR and MDR doubled between 2022 and 2023. However, application completeness remained an issue, with notified bodies estimating that a third of applications were less than 25% complete.
MHRA Draft International Recognition Policy Shows UK Intent On Innovation And Resource Allocation
The MHRA issued a statement on 21 May setting out its draft policy for UK recognition of international regulators’ approvals of medical devices. This will apply in Great Britain, with full implementation expected by 2025.
DeepPsy Launches EEG/ECG Analysis For Precision Mental Health Treatment
Swiss-based start-up DeepPsy aims to streamline mental health care using EEG and ECG biomarkers to better match depression patients with treatments. Co-founder Mateo de Bardeci discusses the company’s vision as it launches its in-house medical device as a service in Switzerland.
AI Assisted Ablation Bests Conventional Procedure, Trial Data Shows
A study by French device firm Volta found an AI-guided ablation procedure was more effective in treating patients with atrial fibrillation, especially those whose symptoms had persisted for six months or longer.
PCCPs, International Harmonization, Nutrition Labels And More AI Updates From FDLI
AI regulation experts discussed the pros and cons of AI “nutrition labels” for transparency, international harmonization of AI regulation and – of course—PCCPs at a recent summit.
Dexcom Announced Launch Of One+ CGM In UK, State Of Type 2 Report
Dexcom launches its highly customizable One+ continuous glucose monitor in the UK as well as a state of type 2 report that suggests 63% of people living with type 2 diabetes have trouble managing their disease.
Regulatory Overhaul Needed For Innovative Techs, Gottlieb Says
In a speech last week, former US FDA Commissioner Scott Gottlieb said establishing dynamic tools, including active registries and firm-based regulation, will be crucial to the FDA’s ability to regulate emerging technologies.
Pair Of Deaths Linked To Latest Recall Of Abbott HeartMate Pump
Abbott has issued a recall of several hundred HeartMate 3 pumps used to support patients with heart failure after reports of blood leakage and air entering the devices.
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