In a real-world study, Eko Health Inc.’s AI-enabled digital stethoscope dramatically increased detection rates for atrial fibrillation, heart failure and valvular heart disease in primary care settings. Researchers from Imperial College London presented results from the study at the European Society of Cardiology in Madrid.

Regulatory and reimbursement challenges in Europe are leading an ever-increasing number of med tech companies to prioritize the U.S. market for the launch of their devices. However, certain technologies can reach European patients more quickly, presenting valuable opportunities with the EU, delegates heard at the LSI Europe ’25 conference in London this week.

The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.

The Office of Inspector General recently reported that billings for remote patient monitoring eclipsed the $500 million mark in 2024, but the agency stated that more scrutiny will be necessary going forward to keep waste, fraud and abuse at bay.

Patients often wait for a long time to see a mental health specialist to get the help they need, and Greymind AI’s mental health platform, Reboot AI, offers a stop-gap measure to provide structured early intervention with built-in escalation to human clinicians.

Lee Dae-hong founded Aivis Inc. in January 2021 as an AI-powered pathology software company, having led the development of the world’s first commercial under-display fingerprint recognition algorithm that was later incorporated into the Galaxy S10 and Galaxy A series of smartphones of Samsung Electronics Co. Ltd.

Aclarion Inc.'s Nociscan, an AI-augmented platform that leverages MR spectroscopy to noninvasively identify the discs causing low-back pain, enables precise targeting of surgical intervention, resulting in 97% success. That’s roughly double the rate of 48% to 54% seen in conventional procedures for discogenic lower back pain, Aclarion CEO Brent Ness told BioWorld.

The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.

Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.

Some Apple Watch users will be able to monitor their blood oxygen levels through their iPhone, thanks to a software update the company planned to issue Aug. 14. The Cupertino, Calif.-based company pulled the feature from its watches in the U.S. in 2024, following a patent dispute with Masimo Corp., of Irvine, Calif., that threatened an import ban.