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Amendments To Breakthrough Device Coverage Act Push Bill Out Of House Ways And Means Committee
The amendment introduced to the Ensuring Patient Access to Critical Breakthrough Products Act in the Ways and Means committee markup of helped usher the legislation to a passing vote.
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EU Regulatory Roundup, May And June 2024: Sweeping New Proposals Take Medtech By Surprise
During this period of intense regulatory pressure for the medtech industry, work has been ongoing in the background to try and find a better way forward for the medtech industry, for innovation and for patients.
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Does The AI Act Apply To My Medtech Product And What Do I Need To Know?
The AI Act is due for publication in July 2024. Marco Caproni of notified body, TÜV SÜD, explained how requirements over and above those in the MDR and IVDR impact medtech manufacturers.
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Philips Disputes Additional Deaths Linked To May Recall Of Breathing Machines
The US FDA is reporting dozens more additional deaths associated with a May recall of Philips ventilators than initially reported. The company says it stands by its original number of seven and has reached out to the FDA.
Spotlight On Conferences
European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'
Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
‘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
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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.
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Global Device Regulation
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FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot
The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices.
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FDA Offers Draft Guidance For Developers Of Drug Delivery Devices
The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.
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News We're Watching: Change Healthcare Details Breach Scope, CHAI Releases AI Assurance Draft, FDA Partners With Gates Foundation
This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.
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Supreme Court Strikes Down Chevron. What’s Next?
A Friday Supreme Court ruling could create uncertainty for the medtech industry by giving judges more latitude to overrule executive-branch decisions. While some pro-business groups applauded the decision, others saw risks as well as benefits.
Digital Health
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News We're Watching: Change Healthcare Details Breach Scope, CHAI Releases AI Assurance Draft, FDA Partners With Gates Foundation
This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.
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Healthtech Leaders Discuss Impact (And Risks) Of Generative AI and AI In Health Care
AI and generative AI ruled much of the discussion at HLTH Europe 2024. A panel of health care leaders from Microsoft, Philips, insitro and Johnson & Johnson discussed how these new technologies are already transforming health care and pointed to risks and challenges.
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AI In Health Care: Speakers At HLTH Europe Conference Discuss Promise And Pitfalls
AI is all the rage these days, so it comes as no surprise that the topic of AI technologies ranked high during the panel discussions at the HLTH Europe event, held from 17-20 June in Amsterdam.
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Floreo CEO Champions FDA Path For Autism VR Therapy
Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.
Interviews
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Floreo CEO Champions FDA Path For Autism VR Therapy
Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.
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‘Is This Doomsday Concern, Or Is It Reality?’ Verily CMO On AI’s Future, Lightpath Metabolic, More
Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.
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Implantica CEO On Potential New Standard Of Care For Treating GERD: RefluxStop
Implantica AG continues European rollout of RefluxStop, a non-active, laparoscopically implanted device for treating gastroesophageal reflux disease (GERD) that offers key advantages over other surgical interventions and drug therapy, according to the company. CEO Peter Forsell discusses global market opportunity and the firm’s growing body of research to support reimbursement.
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AI Act: How To Preserve EU’s Industrial Competitiveness Through Proportionate Regulation
The AI medtech revolution could be a “huge, missed opportunity” for the EU without an effective and efficient regulatory infrastructure. Answers are needed fast, MedTech Europe’s Oliver Bisazza said during a recent interview.
Podcasts
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AMR, UTI, Breathomics And 3D Printing Technology Innovators Profiled At BioWales 2024
Breathomics, UTI diagnosis and advanced wound healing innovations were among the center stage technologies at BioWales in London 2024. Hear from CEO John McKinley on Imspex Diagnostics' plans in embedded podcast.
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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.
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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.
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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.
Recent Stories
FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot
The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices.
FDA Offers Draft Guidance For Developers Of Drug Delivery Devices
The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.
News We're Watching: Change Healthcare Details Breach Scope, CHAI Releases AI Assurance Draft, FDA Partners With Gates Foundation
This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.
Supreme Court Strikes Down Chevron. What’s Next?
A Friday Supreme Court ruling could create uncertainty for the medtech industry by giving judges more latitude to overrule executive-branch decisions. While some pro-business groups applauded the decision, others saw risks as well as benefits.
Healthtech Leaders Discuss Impact (And Risks) Of Generative AI and AI In Health Care
AI and generative AI ruled much of the discussion at HLTH Europe 2024. A panel of health care leaders from Microsoft, Philips, insitro and Johnson & Johnson discussed how these new technologies are already transforming health care and pointed to risks and challenges.
MedTech Forum: Experts Suggest Short And Long-Term Solutions To EU’s Innovation Crisis
After focusing on the severity of the EU’s regulatory innovation crisis, Medtech Insight now reports on discussions in Austria last month on a range of changes that could improve the outlook for cutting-edge products.
Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
MedTech Forum: Is Global Regulatory Convergence Needed To Address EU’s Slow Innovation Exodus?
Does the difference in the height of the respective regulatory bars for innovation in the EU and US matter? And how severe are the problems being created by companies choosing to launch new products outside the EU? Hear the views of speakers at the Medtech Forum in Vienna in this first section of a two-part report from a session at the conference on innovation.
Experts Say LDT Small-Business Compliance Guide Does Little To Persuade
A new FDA lab-developed test compliance guide for small enterprises summarizes agency policy but fails to address clinical lab industry concerns about the LDT final rule.
Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups
New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline.
AliveCor Breakthrough: AI-Powered ECG Systems Cleared To Detect 35 Life-Threatening Cardiac Conditions
AliveCor’s Kardia 12L ECG System with its KAI 12 AI technology is the first AI-powered technology that can detect heart attacks using a portable system with a reduced leadset.
AI In Health Care: Speakers At HLTH Europe Conference Discuss Promise And Pitfalls
AI is all the rage these days, so it comes as no surprise that the topic of AI technologies ranked high during the panel discussions at the HLTH Europe event, held from 17-20 June in Amsterdam.
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