Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Clinical / R & D

Set Alert for Clinical R&D

Clinical Trials

Set Alert for Clinical Trials

France Consults On Best Practice Guidelines For Decentralized Trials

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.

Clinical Trials Guidance Documents

Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials

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.

Australia Clinical Trials

AI Assisted Ablation Bests Conventional Procedure, Trial Data Shows

A study by French device firm Volta found an AI-guided ablation procedure was more effective in treating patients with atrial fibrillation, especially those whose symptoms had persisted for six months or longer.

Commercial Clinical Trials

News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded

This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.

News We're Watching Artificial Intelligence
See All

New Technology

Set Alert for New Technology

Twin Health Extends AI-Powered Program To Help Healthy People Sustain Weight Loss Without GLP-1

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.

Metabolic Disorders Diabetic Care

Click Targets ‘Best-In-Class Digital Therapy For Chronic Weight Management’ With Better Therapeutics Acquisition

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.

M & A Innovation

Telehealth Experts Discuss Access In Health Care Deserts, Overcoming Provider Resistance, Liability Concerns

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.

Digital Health Telehealth

DeepPsy Launches EEG/ECG Analysis For Precision Mental Health Treatment

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.

Europe Switzerland
See All

Approvals

Set Alert for Approvals

News We’re Watching: Panel Backs Guardant Shield, EU Adopts AI Act, Magellan Settles Lead Test Claims

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

Regulation Commercial

EMA Answers More Questions For Manufacturers of Drug-Device Combos

Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.

Europe Approvals

Notified Bodies Double Certifications Since 2022

A recent survey by trade group TEAM-NB found that the number of certificates issued under the IVDR and MDR doubled between 2022 and 2023. However, application completeness remained an issue, with notified bodies estimating that a third of applications were less than 25% complete.

Regulation Approvals

News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded

This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.

News We're Watching Artificial Intelligence
See All
UsernamePublicRestriction

Register