During its fourth-quarter earnings call this week, Inspire Medical disclosed that it has become the subject of a civil probe ...

Some products bought in pharmacies, including tampons and adhesive bandages, are listed as “medical devices” in Taiwan and may not be resold, the Food and Drug Administration (FDA) said yesterday.

After more than six years of development, Angle has scored an FDA ... US for a device used to detect cancer by harvesting cells from a patient blood sample. In a statement, the UK medical device ...

VCS’s innovative and custom-tailored testing services offer specialized cosmetic clinical testing while helping to provide ...

The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...

18 letter stated that FDA found Hologic ... data to support the claim that that spacer material is absorbed by the body." Hologic has received complaints and filed medical device reports to ...

Engineered to specifically act on the vascular endothelial growth factor receptor 2 (VEGFR2), BR55 (perfluorobutane/nitrogen ...

Medical Device Network · surassawadee via Shutterstock. Caranx Medical has submitted TAVIPILOT Soft, an AI-based guide software for use during Transcatheter Aortic Valve Implantation (TAVI) or ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal ...

the settings within the mobile medical app connected to the diabetes device must be configured correctly with the settings within the smartphone itself. To mitigate this issue, the FDA is ...