Artificial intelligence (AI) is no novelty for medical technology, but 2024 saw an interesting series of events in this area from across the globe. While some of these developments portend immediate regulatory clarity, some are harbingers of continued regulatory flux in 2025 and beyond.

When every hour’s delay in treatment increases the risk of death 8%, dialing down time to diagnosis takes on acute urgency for clinicians and regulators. When the disease being treated kills 20% of the global population and 33% of hospitalized patients in the U.S., the market opportunity attracts investors. And when the technology makes breakthroughs possible that cut the time to targeted treatment from days to hours or even minutes, the number of products in development explodes, as the keen competition in sepsis diagnostics covered by BioWorld in 2024 demonstrates.

Companies developing brain-computer interface (BCI) technologies certainly stepped up their activities this year with several starting to implant their devices into humans. After decades as an experimental technology pursued exclusively in research settings, BCI devices could be just a few years away from entering clinical practice – and investors are paying attention.

Dexcom Inc. put real money behind expanding its integration efforts, with a $75 million investment in the $200 million series D for Ōura Health Oy, the maker of the Ōura smart ring. Ōura and Dexcom also provided details on a strategic partnership that integrates data from Dexcom’s continuous glucose monitors with vital sign, sleep, stress, heart health and activity data from the Ōura ring.

Lanua Medical Ltd. raised €6 million (US$6.3 million) in seed funding for its Encore device, which is designed to enhance embolization procedures. The funds will be used to accelerate the development of the technology as well as expand operations into the U.S. The funding round was co-led by Elkstone and Atlantic Bridge, with participation from Enterprise Ireland and Furthr VC.

Edap TMS SA recently published data showing that its Focal One high intensity focused ultrasound technology is non-inferior to radical prostatectomy as a first-line treatment for localized prostate cancer. The company is also working towards gaining approval for the technology as a therapy for endometriosis.

Relation Therapeutics Ltd. has delivered the first commercial validation of its combined wet lab/in silico platform for homing in on disease-related genes in the thick of the genome, signing two collaboration agreements with GSK plc, with a potential value of $200 million per target.

U.K. researchers at Nottingham Trent University, the University of Southampton and University Hospital Southampton and product development company Zelemiq Ltd. developed a wearable sensor that accurately monitors and detects changes in people’s breathing without requiring direct contact with the skin.

Europlaz Technologies Ltd. has developed a new neonatal flow sensor that could help improve neonatal care and save the lives of babies born prematurely. The company created an integrated ‘sidestream’ carbon dioxide (CO2) sampling port, which when added to the side of its existing neonatal flow sensor will enable clinicians to monitor CO2 being exhaled from the baby’s lungs to better inform care.

Positrigo AG is raising $10 million for production and commercialization of its Neurolf brain positron emission tomography system in the U.S. The system hepls to diagnose Alzheimer’s disease. With drugs such as Leqembi and Kisunla gaining U.S. FDA approval to treat the devastating neurological condition, the company is seeing increasing demand for its system, Neurolf CEO and co-founder Jannis Fischer, told BioWorld.