Blog

- Andrew Celentano

Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections

CAMBRIDGE, Mass., Nov. 18, 2025 /PRNewswire/ — Nanopath, a point-of-care diagnostics company enabling high-quality molecular testing in minutes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s novel assay for the rapid detection of infection in patients with suspected, or at risk of, complicated urinary tract infections (UTIs).

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Piccolo Medical® Receives FDA Clearance to Expand ECGuide™ Technology Use to Pediatric and Neonatal Patients

SAN FRANCISCO, Nov. 18, 2025 /PRNewswire/ — Piccolo Medical, Inc. (Piccolo) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Indications for Use for its PM2™ System and ECGuide™ Connector. This clearance extends the technology’s use as an alternative to chest x-ray for a variety of central venous access devices in pediatric and neonatal patient populations.

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Alafair Biosciences Announces First Clinical Use of VersaCoat™ Flowable Hydrogel in Foot & Ankle and Hand & Wrist Procedures

AUSTIN, Texas, Nov. 18, 2025 /PRNewswire/ — Alafair Biosciences, Inc., a medical device company redefining soft-tissue protection in orthopedic surgery, announced today the first clinical use of its VersaCoat™ Flowable Hydrogel (VersaCoat™ Tendon Protector, VersaCoat™ Nerve Protector) by two leading surgeons in lower and upper extremity procedures.

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Heart rate monitor can improve PTSD and chronic pain symptoms

A new study led by researchers from Murdoch University’s School of Psychology, Personalized Medicine Center, and Center for Healthy Aging, Health Futures Institute has found that heart rate variability biofeedback can significantly reduce symptoms of both PTSD and chronic pain—two conditions that frequently co-occur and are notoriously difficult to treat together.

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