Featured Stories
News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded
This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.
Mid-May MDCG Mandate Madness: Pre-empting Questions On Investigator Brochures
Newly issued EU guidance documents make it easier for device companies to draft clinical investigation brochures that will pass authority inspection. They also give insight into what notified body designating authorities check for.
FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device
Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.
Deals Shaping The Medtech And Diagnostics Industries, April 2024
An interactive look at medtech and diagnostics deals made during April 2024. Data courtesy of Biomedtracker.
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
EU Coordination Key To Speeding Up Combined Studies Of Drugs & IVDs/Devices
An EU project has proposed solutions to address key bottlenecks in the approval and conduct of studies that involve the simultaneous investigation of a medicinal product, an IVD and/or a medical device.
FDA Medical Product Communications Need More Nuance To Deter Misinformation, Experts Say
Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.
BSI First Notified Body To Officially Publish Lead Times Under EU Medtech Regulations
BSI says it has no capacity restrictions under the Medical Device Regulation or the IVD Regulation and can start the technical documentation review for the majority of product categories within a month from submission.
Regulatory Reliance: Thai Program With Singapore Provides Cost-Savings, Earlier Innovations
The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.
Digital Health
‘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.
Medtronic Adds AI In Reveal Linq Device To Reduce False Alerts
Medtronic expects that its new AI-powered Reveal Linq insertable cardiac monitor will be able to reduce the number of false AFib and pause alerts by more than 85%.
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.
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.
Interviews
‘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.
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.
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
UK Life Sciences Cautiously Upbeat For Investment Year Ahead – BioWales 2024
Favorable UK biopharma investment trends have been reported by the BioIndustry Association, but can medtech and healthtech share in the positivity? A roundtable at the BioWales in London 2024 event framed the outlook for non-pharma players.
EU Coordination Key To Speeding Up Combined Studies Of Drugs & IVDs/Devices
An EU project has proposed solutions to address key bottlenecks in the approval and conduct of studies that involve the simultaneous investigation of a medicinal product, an IVD and/or a medical device.
FDA Medical Product Communications Need More Nuance To Deter Misinformation, Experts Say
Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.
‘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.
‘If It Wasn’t For NeuroStar, I Wouldn’t Be Here Today,’ Says Teen Patient
A panel of mental health experts, advocates, and patients met recently in Manhattan to discuss the promise of the Neuronetics’ NeuroStar transcranial magnetic stimulation system, which the US FDA recently cleared to treat depression in adolescents ages 15 through 21. It is the first and only treatment of its kind the regulatory agency has cleared for this patient group.
BSI First Notified Body To Officially Publish Lead Times Under EU Medtech Regulations
BSI says it has no capacity restrictions under the Medical Device Regulation or the IVD Regulation and can start the technical documentation review for the majority of product categories within a month from submission.
Regulatory Reliance: Thai Program With Singapore Provides Cost-Savings, Earlier Innovations
The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.
Medtronic Adds AI In Reveal Linq Device To Reduce False Alerts
Medtronic expects that its new AI-powered Reveal Linq insertable cardiac monitor will be able to reduce the number of false AFib and pause alerts by more than 85%.
Shuren: CDRH Needs More Funding For Active Surveillance, Supply Chain Monitoring
In a Tuesday webinar from the Alliance for a Stronger FDA, CDRH head Jeffrey Shuren said that a “politicized and toxic” environment in Washington could limit the agency’s ability to keep up with innovation and responding to new threats.
EU Medical Professions Call For Immediate Measures To Prevent Device Shortages
Their concerns overlap with those of the medtech products industry when it comes to how patients will be impacted unless critical action is taken to improve the EU's Medical Device Regulation.
New China Tariffs Include Higher Rates For Syringes, PPE
Medical products imported from China are among a broad range of items that will be subject to higher tariffs under new federal guidelines. The plan will raise tariffs on some forms of personal protective equipment (PPE) to 25%; additionally, tariffs on syringes and needles will be set at 50%.
Radiology Reigns Supreme: 151 New AI/ML Devices Added In Last 9 Months
Of the 151 AI/ML devices added from August 2023 to March 2024, 117 were radiological devices.
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