Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The World Health Organization has published a report detailing the barriers to digital health’s adoption across the territories in which it operates.

The two tech companies – one software giant, the other focused on oncology – will work together on what will likely be the largest artificial intelligence model of its kind.

Click Therapeutics and Indivior will develop a digital solution for treating substance use disorders, starting with opioid use disorders. Click already signed partnership deals with Otsuka and Verily and Boehringer Mannheim to co-develop digital therapeutics for patients with schizophrenia and major depressive disorder.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The Swedish company has developed a proprietary method of personalizing venous grafts, and plans to bring it – alongside some other products – to the market.

Lifespin is working on tools to characterize a patient’s metabolism and provide more detailed information about a disease.

Ken Block of Ken Block Consulting weighs in on the FDA’s Breakthrough Devices Program, its implications for raising capital, achieving speedier market access, and inviting more intensive regulatory scrutiny in this interview with Medtech Insight.

In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

The European medical device database, Eudamed, is arguably the missing lynchpin in the implementation of the EU’s Medical Device and IVD Regulations. Medtech Insight spoke with Lionel Tussau of atrify to discover what companies need to know now and how actors should be preparing.

In this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations. If you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.

Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.

The UK-based company has just raised $165m support the ongoing commercialization of the Versius robotic platform.

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The US FDA has finalized a guidance document on the Voluntary Improvement Program, which aims to help manufacturers continuously improve quality and compliance.

As a senior advisor for chronic disease, Haider Warraich will help shape policy and product development in several areas, but the FDA provided few details on the cardiologist’s new duties.

The Swedish company has developed a proprietary method of personalizing venous grafts, and plans to bring it – alongside some other products – to the market.

A small scale study has indicated that GLP-1 agonists could restore normal HbA1c levels in type I diabetics. This therapy could be a huge step forward for the treatment of this chronic disease if this benefit is shown in larger studies.

AdvaMed released a report on tactics CMS could use to improve coverage for AI and software.