The US FDA has released a draft guidance from the International Council for Harmonisation that aims to modernize clinical trials. The agency is requesting feedback on the draft, which includes updates on good clinical practices.

Three weeks have gone by now since the European Commission published a “latest update” on the medical device sector pages of its website. What does this mean for the sector?

FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials, and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations, and Kaminski shares a personal story about why the safety of medical devices matters so much to him.

The text of the European Commission’s proposed AI Act is expected to enter the EU high-level negotiation stage within weeks, yet many questions remain as to what the final regulation will entail. Lawyers from Cooley LLP tell Medtech Insight why considerable changes to the text are possible, and what the new law is likely to mean for medtech.

The revised guidance document clarifies the Q-submission meeting process, alternate ways sponsors may obtain FDA feedback, and more.

Three weeks have gone by now since the European Commission published a “latest update” on the medical device sector pages of its website. What does this mean for the sector?

FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.

Less than a month after Philips released test results that it said showed the company’s much scrutinized sleep therapy devices were safe, the FDA has reported more complaints, including deaths, associated with the machines.

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition covers the two clinical studies of Boston Scientific's Emblem MRI subcutaneous implantable cardioverter defibrillator.

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition recaps the presentation of results from EU PORIA, a European registry atrial fibrillation patients treated with Boston Scientific's Farapulse pulsed field ablation system.

An interactive summary of recent executive-level company changes and promotions in the medical device and diagnostics sectors.

FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.

Video game therapy developer Akili Interactive launched a mobile video game therapy to reduce ADHD symptoms in adults. The company plans to seek FDA clearance.

The company will create a handheld version of its FAIMS technology, to be used in rapid testing for transmissible illnesses in combat scenarios.

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition covers the two clinical studies of Boston Scientific's Emblem MRI subcutaneous implantable cardioverter defibrillator.

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition recaps the presentation of results from EU PORIA, a European registry atrial fibrillation patients treated with Boston Scientific's Farapulse pulsed field ablation system.

After a nearly two-year collaboration, Novo Nordisk said it has begun talks to buy a controlling stake in French medical device company Biocorp.

The hospital-to-home care movement is rising, and Inbound Health wants to be at the forefront of enabling health systems and health plans nationwide to bring hospital-level care into the home, now adding general surgery to its offerings.

Allen Burton, the medical director of Abbott’s neuromodulation business and a leader in pain medicine, talked to Medtech Insight about the FDA’s new labeling for Abbott’s spinal cord stimulation devices that includes non-surgical back pain.

The White House Office of Science and Technology Policy has released an updated national strategic framework outlining priorities and goals for federal investment in AI. Industry executive Peter Shen weighs in on the plan.