Samsung Receives FDA Clearance for AI Algorithms that Detect Lung Nodules in Chest X-rays
“This FDA clearance is a huge milestone for Samsung and [...]
Naviswiss Receives FDA 510k Clearance for Naviplan
The Naviplan hip application is CT-based and assists the surgeon [...]
DreaMed Launches its FDA-Cleared Diabetes Management Platform with a Leading U.S. Children’s Hospital
Advisor Pro is the first decision support system to receive [...]
Alpha Tau Receives FDA’s Breakthrough Device Designation for the RX of Recurrent Glioblastoma Multiforme
“As GBM is such a terrible disease, it is critical [...]
FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin
These Mutual Reliance agreements facilitate a coordinated effort between the [...]
FDA Will Follow The Science On COVID-19 Vaccines For Young Children
As schools around the country are re-opening for in-person learning [...]
FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted
As required by statute, a key consideration in their review [...]
Asensus Surgical Receives FDA 510(k) Clearance for Expansion of Machine Vision Capabilities
Additional Intelligent Surgical Unit (ISU) features will further extend augmented [...]
EndoSound Vision Ultrasound System Receives FDA Breakthrough Device Designation
“The Breakthrough Device Designation is evidence of the transformative potential [...]