FDA Grants Breakthrough Device Designation to TOBY's AI-Powered Urine Test for Early Bladder Cancer DetectionBOSTON, June 30, 2025 /PRNewswire/ -- TOBY, Inc., a biotech startup advancing non-invasive ...

"This designation validates the potential of our one-step urine test to detect bladder cancer at its most treatable stage," said Matthew Laskowski, chief executive officer of TOBY. "We now have a ...

In five patients, multiple thrombi were observed to be attached to a single cardiac device lead. No patient with multiple thrombi had clot attached to different leads.

The Hēlo PE Thrombectomy System represents a breakthrough in clot removal technology, featuring a patented dual-action mechanism that integrates powerful aspiration with advanced clot disruption.

Q’Apel Medical has recalled a device for removing blood clots in the brain over an issue linked to two injuries, the Food and Drug Administration said Tuesday. The company asked customers to return ...