Featured Stories
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.
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%.
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.
FDA Warns: Government-Funded COVID-19 Test Not On Cue
The US FDA is warning against the use of Cue Health’s COVID-19 test, which was developed and manufactured with $481m of government funding. A recent inspection found unauthorized alterations to the product.
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
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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
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 review technical documentation for the majority of product categories within a month.
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.
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.
Digital Health
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.
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 its 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.
Interviews
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.
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 its 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.
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
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 review technical documentation for the majority of product categories within a month.
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.
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.
EU Announces Fifth MDR Notified Body Designation In Five Weeks
The latest EU organization to be named under the Medical Device Regulation is based in Austria.
An Ecosystem For Medtech Funding And Innovation Support – BioWales 2024
Creo Medical and Clinithink are among healthtech innovators that have benefited from funding and advisory support offered by the Development Bank of Wales. All three gave a take on the current funding environment at BioWales in London 2024.
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.
Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses
Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.
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.
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.
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.
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