STAT2d
New tests for Alzheimer’s and cancer get FDA’s ‘breakthrough’ status
PathChat, a new AI model for pathology made by Modella AI, received breakthrough status in January. The device can digest ...
Hosted on MSN6mon
ClaroNav expands FDA label for Navident dental imaging system
The US Food and Drug Administration (FDA) has approved a label expansion for ClaroNav’s dental navigation system, Navident EVO, to perform guided endodontic surgeries. Navident uses volumetric ...
JD Supra3d
Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...
Modern Healthcare1mon
Medical device recalls hit a four-year high in 2024. Here’s why
There were 1,048 medical device recalls in 2024, an increase of almost 25% from the 840 recalls that occurred in 2023, according to the Food and Drug Administration. Class I recalls, the most ...