Following AQUA and SCALE PET, the latest FDA clearance reinforces Neurophet's leadership in AI-based Alzheimer's disease imaging analysis; Advanced analysis of neuroimaging featur ...
Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.
Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...
Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
An artificial intelligence (AI)-powered tool that characterizes lung nodules has earned clearance from the FDA, according to ...
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
Medical Device Network on MSN
FDA clears RevealDX’s AI lung nodule diagnostic
RevealDX’s software analyses CT scans and assigns lung nodules with a Malignancy Similarity Index score to aid in lung cancer ...
A neurological-based rehabilitation system to address phantom limb syndrome has been registered by the FDA as a Class II Software as a Medical Device, the manufacturer said in a press release.The ...
Researchers at QED Secure show how a connected wheelchair could be remotely hijacked, highlighting growing cyber risks in medical devices.
The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not ...
Lightweight portable system delivers fast, precise, objective data for rapid aid in diagnosis of concussions in ...
Collaboration underscores MethodSense’s role in accelerating market access and regulatory confidence for advanced ...
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