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Featured Stories

EU’s Future Regulatory Priorities Will Soon Be Solidified So Medtech Must Engage Now

The MedTech Forum looked at why industry should see the outcome of European Parliament elections as an opportunity to help drive through much-needed change.

Europe EU Medical Device

Sen. Paul Leads Effort To Halt FDA’s LDT Final Rule

The Kentucky Republican says the final rule is an overreach by the FDA and will harm patient access to crucial diagnostics, as well as slowing innovation in the sector.

Policy Politics Legislation

Who is Responsible For AI Gone Wrong? Endoscopy Patients Say Doctors, Hospitals

A survey of over 1,000 patients worldwide found that the majority of patients agree that hospitals and endoscopists are responsible for mistakes made by devices that use AI.

Regulation Artificial Intelligence Gastroenterology

France Consults On Best Practice Guidelines For Decentralized Trials

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

Clinical Trials Guidance Documents France

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.

Innovation In Vitro Diagnostics

Medtech Insight Podcasts


This Episode:

Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
 

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.

More Podcasts

Global Device Regulation

Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials

The plan is to create a single platform that would facilitate rapid and streamlined clinical trial approvals and address the challenges sponsors currently face in having to navigate different processes for clinical trials in each state and territory, and within area health services.

Australia Clinical Trials

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

Regulation Commercial

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.

Regulation Policy

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.

Cybersecurity Regulation
Digital Health

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

Regulation Commercial

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.

Metabolic Disorders Diabetic Care

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.

M & A Innovation

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.

Digital Health Telehealth
See All
Interviews

Who is Responsible For AI Gone Wrong? Endoscopy Patients Say Doctors, Hospitals

A survey of over 1,000 patients worldwide found that the majority of patients agree that hospitals and endoscopists are responsible for mistakes made by devices that use AI.

Regulation Artificial Intelligence

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.

Europe 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.

Behavioral Health Neurology

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.

Diversity & Inclusion Regulation
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.

Cybersecurity Digital Health

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.   

Digital Health Approvals

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.

Medtech Connect Artificial Intelligence

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.

Digital Health Roundup Artificial Intelligence
See All
Recent Stories

Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials

The plan is to create a single platform that would facilitate rapid and streamlined clinical trial approvals and address the challenges sponsors currently face in having to navigate different processes for clinical trials in each state and territory, and within area health services.

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

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.

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.

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.

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.

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