Week of July 17, 2023

This week, we spotlight the U.K.’s delayed association with Horizon Europe and its impact on the medtech sector. We also delve into a novel discovery in MRI imaging and the Food and Drug Administration’s approval of a new treatment for preventing the respiratory syncytial virus, known as RSV, in young children. Additionally, we look at the FDA’s clearance of an artificial intelligence-driven ECG-interpretation platform. Lastly, we examine Congress’ ongoing discussion on easing regulations for the air transport of donated organs.

Each week we highlight five things affecting the life sciences industry. Here’s the latest.

The U.K.’s delay in finalizing an association with Horizon Europe, the European Union’s research and innovation funding program, is hurting the medtech sector. Rejoining Horizon could offer U.K. medtech innovators opportunities to secure more funding for medical innovation, especially in AI, which may be crucial for the industry’s future growth.

Researchers made a groundbreaking discovery of a novel copper protein binding site with potential use in MRI (magnetic resonance imaging) contrast agents. This overturns previous beliefs about copper’s suitability for such agents and offers new possibilities for safer and more effective imaging. The copper-based structure displayed promising contrast-agent capabilities, comparable to Gd(III) agents commonly used in clinical MRI. This advancement could lead to the development of innovative and improved imaging tools for medical scans.

The FDA has approved Beyfortus, a new treatment for preventing RSV lower respiratory tract disease in neonates, infants and children up to 24 months. RSV is a significant cause of respiratory infections in this age group, leading to hospitalizations and health care visits. Beyfortus is a monoclonal antibody that mimics the immune system’s response to fight RSV. Clinical trials showed that Beyfortus reduced the risk of RSV lower respiratory tract infection by approximately 70% to 75% compared to a placebo.

The FDA has granted clearance to AccurKardia’s AccurECG system, an automated platform for interpreting electrocardiograms. The software uses AI to process ECG data from a range of compatible devices, conducting detailed analyses of each heartbeat and identifying potential cardiac condition indicators. The system is capable of producing a diagnostic report in a matter of minutes, identifying up to 13 different abnormal heart rhythms. According to a retrospective study submitted to the FDA, the software demonstrated a sensitivity of approximately 96% and a specificity of around 99%. The cloud-based nature of the software allows for integration into existing cardiac workflows in various health care settings.

Congress is considering changes to Federal Aviation Administration regulations that could ease the air transport of donated organs. The proposed amendments, which are part of a larger bill to reauthorize the FAA, would allow organs to be transported in the cabin rather than the cargo hold of aircraft. This move is aimed at addressing the challenges faced by organ procurement organizations due to current regulations that treat organs as cargo. These regulations, implemented post 9/11, require organs to arrive at the airport one to two hours before takeoff, potentially causing delays. The bill, which includes these proposed changes, faces a deadline of September 30 for approval.

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