The US Food and Drug Administration (FDA) has granted 510(k) clearance for Philips’ SmartSpeed Precise deep learning reconstruction software. This dual AI software is said to deliver up to three ...

Tom Teisseyre, Chief Operating Officer at Hyperfine, added: “Optive AI™ software is our tenth software release since initial FDA clearance and marks a critical inflection point in the ...

Leading integrated radiotherapy systems maker Varian Medical Systems (NYSE:VAR - News) recently stated that it has obtained the 510 (k) clearance from the U.S. Food and Drug Administration (“FDA ...

Inspirata’s software has been available since January 2021, after the FDA announced it would temporarily waive the requirements for some digital programs to obtain a 510 (k) clearance during the ...

The software application calculates PHM, which precisely measures liver function. The technology also automates the Quantitative Liver Spleen Scan that has recently been proven to be an accurate ...

Hyperfine Announces FDA Clearance of Optive AI™ Software, Introducing the Most Substantial Image Quality Improvement Ever for the Swoop® System Provided by Business Wire May 28, 2025, 6:00:00 AM ...

All IHC breast markers in the Ventana portfolio have both image analysis and digital read application FDA 510 (k) clearances. Along with the Companion Algorithm ER (SP1) image analysis software ...

3Shape has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for its 3Shape Ortho System 2017 software. The market clearance includes the company's digital indirect bonding ...

AI Metrics has earned FDA clearance for its software. UAB spinoff company AI Metrics LLC has received a United States Food and Drug Administration 510(k) clearance and CE mark clearance for the ...

Trial will test informatics software used in Warfarin dosing. Louisville-based PGXL Laboratories has received an OK from regulators to conduct clinical trials on its informatics software, called ...