Nanox

AI is used to screen large volumes of ECG data from patches, wearables and remote monitors, flagging possible arrhythmias or recordings that need clinician review. This helps manage the large amount of data produced by continuous monitoring.

Important distinctions for buyers:

• A consumer feature on a wearable and a clinical-grade analysis service can have very different intended uses and authorizations.
• Authorization often covers specific recording hardware, leads and populations.
• Signal quality and motion artifacts affect results.

In the US, software that analyzes physiological signals does not meet the criteria for non-device CDS. Confirm each product's status, and check how alerts are routed to clinicians and documented.

General diagnostic imaging software stores, displays and manipulates images, for example PACS viewers, 3D reconstruction or measurement tools operated by the user. Radiology AI adds automated analysis that produces its own output, such as a detection, triage flag or quantitative result.

The distinction matters for evaluation:

• Viewing and processing tools are judged mainly on image quality, usability and integration.
• AI analysis tools also need evidence on accuracy, populations studied, failure modes and monitoring.

Both can be regulated medical devices depending on intended use; in the US many image management and processing functions fall under device classifications. Many vendors now combine the two, so ask which functions are AI-based and which are covered by a regulatory authorization.

AI image reconstruction and denoising use deep learning to produce clearer images from raw scanner data or to reduce noise and artifacts, for example in CT or MRI. Vendors often position these tools as supporting lower-dose or faster scanning protocols.

Unlike detection software, these tools change the image the clinician reads rather than adding a finding. Questions to ask include:

• Is the function built into the scanner or a separate software product?
• Which scanners, protocols and body regions is it authorized for?
• How was diagnostic image quality evaluated, and could fine detail be lost or altered?

These functions are typically regulated as part of the imaging device or as image processing software, depending on the product and market.