Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...

RevealDX’s software analyses CT scans and assigns lung nodules with a Malignancy Similarity Index score to aid in lung cancer diagnosis.

Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.

Growth is fueled by rising adoption of wearable healthcare devices, advanced patient monitoring systems, and AI-driven ...

Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...

On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...

India agrees to ease non-tariff barriers for US medical devices, but domestic industries seek reciprocity to ensure balanced ...

Researchers at QED Secure show how a connected wheelchair could be remotely hijacked, highlighting growing cyber risks in medical devices.

FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...

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 ...

New capability delivers end-to-end traceability across all product development data, connecting milestones, decisions, and evidence across every phase of the medical device lifecycle.

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