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.

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.

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.

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.

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.

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.

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

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.

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 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.

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.

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.

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.

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.

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.

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.   

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

The FDA’s updated guidance on internet responses to misinformation adds considerations for a post-COVID, social media influencer world. 

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks makes minor changes to its phthalates benefit-risk guidelines based on stakeholder feedback. The guidelines could be increasingly relevant given their applicability to other carcinogenic, mutagenic or reprotoxic (CMR) and endocrine-disrupting (ED) substances, lists that are bound to go on growing as the EU implements its Chemicals Strategy for Sustainability under the Green Deal.