Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one. 

This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.

A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion

This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.

Medtech Insight talked to GreyBird Ventures founder Tom Miller about his investment philosophy, ethical filter in selecting diagnostics-focused start-ups, the future of diagnostics such as at-home home-testing and AI, and his life-long passion for motocross racing. 

Postmarket surveillance of AI/ML is a continuing issue for regulation, DHCoE acting assistant director MiRa Jacobs says.

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 company has developed a method to convert DICOM images into 3D holograms that can be projected onto VR headsets. Medtech Insight caught up with CEO Alison Sundset to find out how Holocare is paving the way for a more integrated, collaborative form of pre-surgical planning.

Medtech Insight talked to GreyBird Ventures founder Tom Miller about his investment philosophy, ethical filter in selecting diagnostics-focused start-ups, the future of diagnostics such as at-home home-testing and AI, and his life-long passion for motocross racing. 

Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.

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.

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.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one. 

The $1.1bn acquisition of drug-eluting balloon developer MedAlliance will help Cordis return to its roots as an innovative leader in interventional cardiology.

The company has developed a method to convert DICOM images into 3D holograms that can be projected onto VR headsets. Medtech Insight caught up with CEO Alison Sundset to find out how Holocare is paving the way for a more integrated, collaborative form of pre-surgical planning.

This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.

A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion

The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.

The diagnostic company has secured more government funding for DeepView, a product it has developed to assess the healing of certain types of wound. In total, BARDA has supported SpectralMD with almost a quarter of a billion dollars.

The US FDA appears poised to release long-promised regulations on lab-developed tests. However, some industry observers still have doubts as to whether the agency is truly prepared. 

Harbinger Health has raised a total of $190m since its founding in 2021. Its CEO Stephen Hahn told Medtech Insight in March that the company plans to develop a blood-based cancer test that is affordable, accessible and also more accurate than currently available tests.

A new draft global harmonization plan from the device center at the US Food and Drug Administration may not contain any surprises, but it does highlight increasing agency engagement with international bodies.

The surgical robotics start-up may be de-listed from the New York Stock Exchange (NYSE) due to its low current share price. Some analysts believe the company can survive long enough to earn FDA de novo clearance for its robotic surgical system.