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Featured Stories

AI Act Is Officially Published: Implementation Challenges Ahead For Medtech

The final text of the AI Act is now available for all to read but, for medtech, it may feel that work is only just beginning.

Europe EU Medical Device

Device Center Announces Organizational Changes, Including New Marketing Division

The US FDA’s Center for Devices and Radiological Health is making key structural changes it says will help the center run more smoothly, including the addition of a new marketing and communications division.

FDA Policy Restructuring

Fatty Liver Disease Drug Approval Opens New Patient Population In Imaging Market

The accelerated approval of Rezdiffra, the first drug authorized by the FDA to treat metabolic dysfunction-associated steatohepatitis (MASH), presents a large opportunity for imaging and diagnostic devices.

Regulation Liver & Hepatic Medical Device

Cumulus Neuroscience Joins Transatlantic Hunt For Alzheimer’s Blood And Digital Biomarkers

Cumulus Neuroscience has been granted £1.2m from Innovate UK to validate AccelADx, an AI-powered, non-invasive Alzheimer’s screening test that combines EEG and tablet-based assessments, as part of a transatlantic study investigating digital and blood-based biomarkers for Alzheimer's dementia.

Research & Development Financing Diagnostics

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.

Europe EU

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.

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Global Device Regulation

FDA Drops Final Guidance On Devices Designed To Treat Opioid Abuse

The FDA has published final guidance to assist developers of medical devices designed to treat opioid use disorder, along with considerations for sponsors of clinical studies to evaluate those devices.

FDA Guidance Documents

WHO Launches 'One-Stop Shop' For Global Information On Medical Devices

The Medical Devices Information System (MeDevIS) platform, launched by the WHO this week, consolidates information on 2,301 device types and streamlines device nomenclature to support informed decision-making by governments, regulators, payers, and healthcare providers.

International Supply Chain

Philips Was Correct In Disputed Death Reports, FDA Confirms

Last month, the US FDA increased the number of injuries and deaths initially reported in a March recall from Philips, which the company disputed. The FDA now says its adjusted numbers were in error.

FDA Recalls

Sinaptica’s Breakthrough Device Could Slow Brain Atrophy In Alzheimer’s Patients – Study

In a pilot study building on previously published Phase 2 trial results, Sinaptica’s precision therapy, combining repetitive transcranial magnetic stimulation with EEG monitoring and artificial intelligence, showed macro- and micro-structural grey matter preservation and increased functional connectivity in Alzheimer’s patients versus a sham treatment arm.

Research & Development Financing
Digital Health

Clinicians: ‘Show Me The Impact And Outcomes Of AI Tools’

Royal Philips’ ninth annual Future Health Index global report reveals a growing acceptance by clinicians and health care stakeholders of virtual care and AI-enabled innovation. These tools can address workforce shortages, financial burdens and growing demand for care, said chief innovation and strategy officer Shez Partovi.

Leadership Artificial Intelligence

News We’re Watching: FDA Issues Monkeypox EUAs, IMDRF Publishes AI Principes, Quest Buys LifeLabs

This week, the US FDA authorized EUAs for at-home mpox tests and announced a public workshop on implanted brain devices; the IMDRF published guiding principles on good machine learning practices for AI; and Quest announced its deal to acquire a Canadian diagnostic firm.

Regulation Commercial

Class I Device For Methadone Dosing Decreases Costs, Save Lives

Sonara Health founder Michael Giles talks take-home methadone treatments, remote patient monitoring and sponsoring legislation to fund opioid treatment programs.

Behavioral Health Digital Health

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.

Regulation Digital Health
See All
Interviews

Fatty Liver Disease Drug Approval Opens New Patient Population In Imaging Market

The accelerated approval of Rezdiffra, the first drug authorized by the FDA to treat metabolic dysfunction-associated steatohepatitis (MASH), presents a large opportunity for imaging and diagnostic devices.

Regulation Liver & Hepatic

Lucid Diagnostics Seeks Clear Path To US Reimbursement For Esophageal Precancer Test

Lishan Aklog, CEO of New York-based Lucid Diagnostics, has a long-term vision to provide the paradigm of prevention-to-treatment care for esophageal cancer. In the short term, the company anticipates a favorable outcome from an upcoming pivotal Medicare assessment of its early screening technology.

Innovation Cancer

Endoron Staples Down $10M To ‘Revolutionize’ Abdominal Aortic Aneurysm Repair

Endoron Medical won $10m in series A funding from European venture capital firm Sofinnova Partners and the European Innovation Council Fund. The capital will propel Aortoseal – Endoron's endograft stapling solution for abdominal aortic aneurysm – through clinical validation in its US Food and Drug Administration early feasibility study.

Europe US States

Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

FDA Patents
Podcasts

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.

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.

United Kingdom Innovation

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
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Recent Stories

News We’re Watching: Roche Patent Suit, Dental Device Guidance Docs, Edwards Partners With Affluent Med

This week, Roche filed suit against Foresight Diagnostics and Stanford University over patent infringement; the former head of a COVID-19 test company was convicted of securities fraud; and Baxter announced a recall of Life2000 ventilators.

FDA Drops Final Guidance On Devices Designed To Treat Opioid Abuse

The FDA has published final guidance to assist developers of medical devices designed to treat opioid use disorder, along with considerations for sponsors of clinical studies to evaluate those devices.

WHO Launches 'One-Stop Shop' For Global Information On Medical Devices

The Medical Devices Information System (MeDevIS) platform, launched by the WHO this week, consolidates information on 2,301 device types and streamlines device nomenclature to support informed decision-making by governments, regulators, payers, and healthcare providers.

Philips Was Correct In Disputed Death Reports, FDA Confirms

Last month, the US FDA increased the number of injuries and deaths initially reported in a March recall from Philips, which the company disputed. The FDA now says its adjusted numbers were in error.

Lucid Diagnostics Seeks Clear Path To US Reimbursement For Esophageal Precancer Test

Lishan Aklog, CEO of New York-based Lucid Diagnostics, has a long-term vision to provide the paradigm of prevention-to-treatment care for esophageal cancer. In the short term, the company anticipates a favorable outcome from an upcoming pivotal Medicare assessment of its early screening technology.

Endoron Staples Down $10M To ‘Revolutionize’ Abdominal Aortic Aneurysm Repair

Endoron Medical won $10m in series A funding from European venture capital firm Sofinnova Partners and the European Innovation Council Fund. The capital will propel Aortoseal – Endoron's endograft stapling solution for abdominal aortic aneurysm – through clinical validation in its US Food and Drug Administration early feasibility study.

Sinaptica’s Breakthrough Device Could Slow Brain Atrophy In Alzheimer’s Patients – Study

In a pilot study building on previously published Phase 2 trial results, Sinaptica’s precision therapy, combining repetitive transcranial magnetic stimulation with EEG monitoring and artificial intelligence, showed macro- and micro-structural grey matter preservation and increased functional connectivity in Alzheimer’s patients versus a sham treatment arm.

FDA's LDT Overhaul Should Go Back To Congress, Appropriations Report Says

A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics. 

Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

Syphilis OTC Test Developer NOWDiagnostics Raises $22.5M

The Series B funding round led by DigitalDx Ventures will support development and commercialization of more than 30 rapid diagnostic tests in NOWDx’s clinical research pipeline, including its First To Know Syphilis OTC test, currently under US FDA De Novo review, which provides at-home results in minutes.

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.

Clinicians: ‘Show Me The Impact And Outcomes Of AI Tools’

Royal Philips’ ninth annual Future Health Index global report reveals a growing acceptance by clinicians and health care stakeholders of virtual care and AI-enabled innovation. These tools can address workforce shortages, financial burdens and growing demand for care, said chief innovation and strategy officer Shez Partovi.

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