The director of the US FDA’s Office of Science and Engineering Laboratories said there’s a future for synthetic datasets in the Regulatory Science Tools catalog.

In this amendment to both the Medical Device and IVD Regulations, the IVD Regulation timelines will be eased and Eudamed will be rolled out before the entire database is ready.

Stakeholders say the US FDA’s Q-sub guidance could use some tweaking, especially for identifying when informal meetings with the agency are more appropriate than formal ones and creating less burdensome timelines.

Exergen seeks a declaration from Massachusetts federal court that claims challenged by Baxter in the National Advertising Division forum regarding the accuracy of its thermometers do not constitute false or misleading advertising, if they are even advertising at all.

This week, an FDA advisory panel recommended approval of the Guardant Shield blood test for colon and rectal cancers; the EU Council signed off on the world’s first AI law; and the FDA challenged innovators to develop AI/ML technologies to detect gait freezing in individuals with Parkinson’s disease

Twin Health extends its whole-body digital twin AI platform to help people who are overweight or obese achieve a healthy weight without the use of medications.

Click will fold Better Therapeutics’ FDA-cleared AspyreRx prescription digital therapeutic into R&D for its own CT-181, which promises to optimize obesity treatment in combination with drugs such as GLP-1s and provide "valuable real-world data insights for providers and payers." Better Therapeutics shuttered its operations in March, signaling continued challenges for digital medicine innovators.

Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.

Device attorney Jason Brooke says that the FDA’s recent guidance document on device remanufacturing represents a “missed opportunity” to discuss software.

US FDA neurological device office head David McMullen is watching digital health tools make mental health treatments more widely available than ever before, though the expansion comes with some risks. Medtech Insight spoke with him about the FDA’s role in this growing field.

A survey of over 1,000 patients worldwide found that the majority of patients agree that hospitals and endoscopists are responsible for mistakes made by devices that use AI.

Swiss-based start-up DeepPsy aims to streamline mental health care using EEG and ECG biomarkers to better match depression patients with treatments. Co-founder Mateo de Bardeci discusses the company’s vision as it launches its in-house medical device as a service in Switzerland.

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.   

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Verily’s CMO and CSO, Andrew Trister at ViVE on leveraging AI for precision health and a DHIS West conference panel discussion on use cases of generative AI. Elizabeth Orr discusses the impact on the newly adopted EU AI Act on device makers and concerns raised by industry members.

The director of the US FDA’s Office of Science and Engineering Laboratories said there’s a future for synthetic datasets in the Regulatory Science Tools catalog.

In this amendment to both the Medical Device and IVD Regulations, the IVD Regulation timelines will be eased and Eudamed will be rolled out before the entire database is ready.

Stakeholders say the US FDA’s Q-sub guidance could use some tweaking, especially for identifying when informal meetings with the agency are more appropriate than formal ones and creating less burdensome timelines.

Exergen seeks a declaration from Massachusetts federal court that claims challenged by Baxter in the National Advertising Division forum regarding the accuracy of its thermometers do not constitute false or misleading advertising, if they are even advertising at all.

Industry will be well acquainted with the proposal's content since it reflects its own work on the much-needed further development of the Medical Device Regulation

A survey of over 1,000 patients worldwide found that the majority of patients agree that hospitals and endoscopists are responsible for mistakes made by devices that use AI.

The MedTech Forum looked at why industry should see the outcome of European Parliament elections as an opportunity to help drive through much-needed change.

The Kentucky Republican says the final rule is an overreach by the FDA and will harm patient access to crucial diagnostics, as well as slowing innovation in the sector.

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

The plan is to create a single platform that would facilitate rapid and streamlined clinical trial approvals and address the challenges sponsors currently face in having to navigate different processes for clinical trials in each state and territory, and within area health services.

This week, an FDA advisory panel recommended approval of the Guardant Shield blood test for colon and rectal cancers; the EU Council signed off on the world’s first AI law; and the FDA challenged innovators to develop AI/ML technologies to detect gait freezing in individuals with Parkinson’s disease

Just as concerns are growing in the sector about how notified bodies will manage simultaneous surges in requests for recertification and legacy devices around 2027/28, the European Parliament has launched a key initiative.