The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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’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 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.

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.