Nephrodite Inc.'s Holly, an implantable, continuous renal replacement system, received U.S. FDA breakthrough device designation as a novel and potentially life-changing treatment for end-stage kidney disease. The system is designed to enable continuous blood filtration and allow patients freedom to go about their days without frequent, hours-long visits to a dialysis clinic or being hooked up to a filtration system at home.

Levron Medical Ltd. recently exited stealth mode to advance its cardio-respiratory physiology assist technology, designed to treat heart failure by synchronizing the heart and lungs. The approach harnesses the natural ‘respiratory pump’ to assist cardiac function and create what the company claims to be a new category of heart failure treatment.

Tulyp Medical Inc. has emerged from stealth mode with a pressure-driven perfusion system designed to improve vascular procedures. The company, born out of Sofinnova Partners' medical device accelerator, has submitted the technology to the U.S. FDA for 510(k) clearance following initial clinical results that demonstrated safety and functionality.

The largest study ever conducted on light therapy for Parkinson’s disease has found that long-term use of Symbyx Biome Pty Ltd.’s non-invasive, at-home photobiomodulation (PBM) devices significantly improved mobility, anxiety, and overall symptom severity.

SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture (JV) called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management.

Newco Trogenix Ltd. has emerged from incubation and raised £70 million (US$94.1 million) in a series A, as it prepares the ground for a U.S/U.K. clinical trial of a novel gene therapy construct in glioblastoma multiforme that is due to start at the beginning of 2026.

IMU Biosciences Ltd. is working to transform society’s understanding of the immune system. The company’s platform maps the immune system at molecular, cellular and system levels, to unlock new insights into immune-related health and diseases, paving the way for clinical applications that could improve patient outcomes.

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.

Recently launched Irish startup Phyxiom Ltd. hopes that its digital health platform will transform the clinical outcomes for patients with asthma and chronic obstructive pulmonary disease. By providing clinicians with real-time insights into lung function and medication adherence, the platform improves diagnosis accuracy and treatment outcomes.

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.