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China Moves From Administrative Orders To Medtech Law – Consultation Underway
After high-level deliberations, a draft Medical Device Administration Law to supersede the series of medical devices administrative orders has been issued by the Chinese State Food and Drug Administration. A stakeholder consultation is underway.
Abbott’s Share-Gobbling Aveir DR Leadless Pacing System Introduced To UK
The firm’s dual-chamber leadless pacemaker system with is expected to be a growth driver for Abbott and already has acquired approximately 30%-40% of market share from Medtronic since its approval by the US FDA in July 2023, according to GlobalData.
Opinion: Is The EU Recreating A Different Monster Of A Regulatory Labyrinth?
Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?
News We’re Watching: Trial Lab Warning Letters, Novartis Adds US Plants, Abbott Launches OTC Lingo Glucose Monitor
This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands.
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
Mammograms Should Inform Women About Breast Density, FDA Says
The US FDA now requires mammograms include information about breast density, a significant factor that raises breast cancer risk and can hide tumors.
Prodded By Congress, FDA Launches Tampon Review
The US agency said on 10 September that it plans to study whether heavy metals detected in tampons could endanger their users.
LSX Medtech Panelists Talk AI, Market Access Strategies, Digital Therapeutics Reimbursement
Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston.
First Stage Of UK NHS Review 2024: Darzi Delivers His Early Verdict
Can the new UK government's raw enthusiasm for NHS reform be a catalyst for real change where countless past attempts to address the national provider's shortcomings have failed to hit the spot? And what might the 10-year plan mean for medtech?
Digital Health
LSX Medtech Panelists Talk AI, Market Access Strategies, Digital Therapeutics Reimbursement
Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston.
German, California Firms Offer Digital Access To Mental Health Content For Menstrual Cycle, Fertility
Clue Plus members will have access to 50% off a Headspace subscription for tailored guidance, support and validation to help manage cycle-related stress and improve overall well-being.
Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
Medtech Warming Up To Benefits Of Australia’s Teletrials Initiative
The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.
Interviews
Video: How To Efficiently Patch A Medtech Regulatory System ‘Set Up To Fail’
Centralization and rationalization of the EU’s medtech rules are critical, particularly for conformity assessment and clinical evidence. Hear the views of Tom Melvin and Erik Vollebregt first-hand in a new in-depth interview on regulatory problems and opportunities.
Exact Sciences Looks Ahead As Cologuard Marks 10th Anniversary
Exact Sciences’ Cologuard at-home colorectal cancer screening test was the first of its kind when it was introduced to the US market in 2014. What’s ahead for the company as its flagship product moves into its second decade? Medical director Paul Limburg spoke to Medtech Insight about the potential of home cancer screening.
Medtech Warming Up To Benefits Of Australia’s Teletrials Initiative
The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.
Truvian CEO Confident Blood-Testing Benchtop Could Be ‘Any Place You Go’
During a tour of Truvian’s San Diego headquarters, Medtech Insight spoke with the company’s top executives about their unique three-in-one blood-testing benchtop system, plans for FDA regulatory filing, and marketing strategy.
Podcasts
Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
Digital Health Roundup: Brain Talk On Seizures, Alzheimer's, Stress, Anxiety; Medtronic's OR Report; Health Care AI; UK Guidances
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room.
Medtech Connect 16: AI For Cross Border Regulation
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.
Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Recent Stories
Mammograms Should Inform Women About Breast Density, FDA Says
The US FDA now requires mammograms include information about breast density, a significant factor that raises breast cancer risk and can hide tumors.
Prodded By Congress, FDA Launches Tampon Review
The US agency said on 10 September that it plans to study whether heavy metals detected in tampons could endanger their users.
LSX Medtech Panelists Talk AI, Market Access Strategies, Digital Therapeutics Reimbursement
Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston.
First Stage Of UK NHS Review 2024: Darzi Delivers His Early Verdict
Can the new UK government's raw enthusiasm for NHS reform be a catalyst for real change where countless past attempts to address the national provider's shortcomings have failed to hit the spot? And what might the 10-year plan mean for medtech?
ISS Named As Italy’s First Notified Body Under The EU’s IVD Regulation
After a hiatus of nearly a year, the EU can celebrate another designation under the IVD Regulation.
Withings Headed For Patients’ Bedrooms With Under-The-Mattress Sleep Apnea Diagnostic
Withings is touting the FDA-cleared Sleep Rx Map as an alternative to costly, inconvenient overnight stays in sleep labs, and its solution could be more efficacious than polysomnography due to the longitudinal data it captures, the firm says. There are other at-home tests available for diagnosing sleep apnea, but Withings’ device is contactless.
2024’s Medtech Venture Investment Climate Warmer Than 2023. Will It Last?
Venture investment in medtech seems to be improving, particularly in diagnostics and tools, and down-value rounds have decreased. However, interest rates are still much higher than three years ago, and many tech investors continue to avoid the health care sector as a whole.
‘Catastrophic’ Risk Linked To Smiths Medical Trach Tubes
Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.
US Eroxon Launch In October Will Mark Haleon’s First Foray Into Sexual Health
Haleon will launch Futura Medical's FDA-approved OTC medical device for erectile dysfunction in the US before the end of the year. Already available to pre-order online on Amazon, Eroxon represents the firm's first move into the sexual health category.
Lab Association Asks Congress To Kill FDA’s Final Rule On LDTs
In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.
German, California Firms Offer Digital Access To Mental Health Content For Menstrual Cycle, Fertility
Clue Plus members will have access to 50% off a Headspace subscription for tailored guidance, support and validation to help manage cycle-related stress and improve overall well-being.
Apple Adds Sleep Apnea Detection, Hearing Health Features To Selected Wearables
Apple is introducing new health features in conjunction with its launch of the Series 10 Apple Watch and AirPods Pro 2 earbuds, which soon will be able to monitor for potential sleep apnea and function as a clinical-grade hearing aid, respectively, pending regulatory clearances in the US and other countries around the globe.
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