DURHAM, N.C., April 23, 2025 /PRNewswire/ — Baebies has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Anti-Factor Xa test on the FINDER® platform —the first point-of-care heparin monitoring assay. Designed for patients receiving unfractionated or low molecular weight heparin, the test provides results in under 15 minutes from just 50 µL of whole blood. This designation recognizes the test’s potential to bring heparin monitoring closer to the patient, enabling faster and more effective dose management in critical care settings.

SEOUL, South Korea, April 23, 2025 /PRNewswire/ — CGBIO(CEO Hyun Seung Yu), a leading Korean company specializing in bio-regenerative medicine, proudly announces that its innovative bone graft substitute, NOVOSIS PUTTY, has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This pivotal approval paves the way for a clinical trial in spinal fusion procedures within the United States.

Researchers at Umeå University, Sweden, have discovered a previously unknown type of connective tissue cells that surround cancer cells in pancreatic tumors. The newly discovered cells counteract tumor development and may therefore be a target for research into new treatments for pancreatic cancer, which is one of the deadliest forms of cancer. The work is published in the journal Cancer Research.

Scientists at the National Institutes of Health (NIH) have leveraged artificial intelligence to transform a device designed to see tissues in the back of the eye into one sharp enough to make out individual cells. The technique provides imaging resolution that rivals the most advanced devices available and is cheaper, faster, and doesn’t require specialized equipment or expertise. The strategy has implications for early detection of disease and for the monitoring of treatment response by making what was once invisible now visible.

Caltech professor of medical engineering Wei Gao and his colleagues are envisioning a smart bandage of the future—a “lab on skin” that could not only help patients and caregivers monitor the status of chronic wounds but also deliver treatment and speed up the healing process for those cuts, incisions, scrapes, and burns that are slow to heal on their own.

This advancement expands the capabilities of how researchers can study disease and build tissues for therapy, such as type 1 diabetes.

The technology, which achieves single-cell resolution, could help in continuous, noninvasive patient assessment to guide medical treatments.

Epiminder announced today that it received FDA de novo authorization for its implantable continuous electroencephalogram monitoring (iCEM) system.

NeuroOne (Nasdaq:NMTC) announced today that it filed an FDA 510(k) submission for its trigeminal nerve ablation technology.