The Image Quality Analyzer software system received 510 (k) clearance from the FDA, VisionQuest Biomedical announced in a press release.The software system prompts eye care professionals to retake ...

The FDA has granted 510 (k) clearance to a Canadian neuroimaging company for its quantitative imaging software, which assists neurologists and radiologists dealing with brain white matter issues ...

GUILFORD, Conn., May 28, 2025--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the world’s first FDA-cleared AI-powered ...

GUILFORD, Conn., June 02, 2025--FDA clears next-gen Swoop® MRI system with Optive AI™ software, bringing a transformative leap in image quality with enhanced usability and comfort.

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 ...

Abbott landed FDA clearance for its imaging software, which employs artificial intelligence to give doctors a clearer look at blood flow and blockages in heart vessels. The Ultreon 1.0 Software pairs ...

ClearPoint Neuro, Inc. CLPT, a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, recently received FDA’s 510 (k) clearance for its ...

In the clinical study which underpins the FDA clearance, all readers in the study, which included pulmonologists and radiologists of various levels of expertise, from generalists to experts ...

Adeniyi said the software follows experiences with previous service providers who, “despite multiple contract extensions, failed to meet their deliverables and failed to handover at the end of ...

He stated that the software was developed following experiences with previous service providers who, “despite multiple contract extensions, failed to meet their deliverables and did not hand ...