Other AI medical devices

A neutral, evidence-based catalogue of other AI medical devices. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.

Other

Tyto Insights for Eardrum Bulging Detection

Tyto Care, Ltd.

FDA

Tyto Insights for Eardrum Bulging Detection is over-the-counter, web-based software that analyses otoscopy video recorded with Tyto Care's compatible digital otoscope and automatically detects bulging of the tympanic membrane — a cardinal sign of acute otitis media — in patients aged six months and older. Its March 2026 De Novo created the FDA's "ear, nose, and throat image analyzer" device type, making it the first AI eardrum-analysis software authorised in the US (a novelty the manufacturer's announcement leads with). A gating quality filter rejects recordings that never show a usable view of the eardrum before any clinical inference is attempted; results go to healthcare providers as a clinical-support aid, and a provider's advice is required to understand their meaning. The software is explicitly not intended to provide a diagnosis.

Other

Sleep Apnea Notification Feature (SANF)

Apple Inc.

CEFDAHCTGA

Over-the-counter software feature on Apple Watch that estimates breathing disturbances during sleep from the watch's triaxial accelerometer — no airflow sensor, no pulse oximetry — and, when those disturbances are elevated across nights in a 30-day window, notifies the wearer that the pattern is consistent with moderate-to-severe obstructive sleep apnoea. The feature screens; it does not diagnose. Its notification is an instruction to talk to a clinician, and by regulatory design it is restricted to adults without a prior sleep-apnoea diagnosis.

Other

Oxehealth Vital Signs

Oxehealth Limited

CEFDA

Software-only device that measures pulse rate and breathing rate from the video of a fixed near-infrared camera in a single-occupancy room, with nothing attached to the patient. Pulse comes from small changes in the brightness of exposed skin; breathing from tracking the chest wall. It gives a spot reading when staff ask for one and the subject is still, and nothing when conditions are not met. It is the vital- signs module of the Oxevision platform used on NHS mental-health wards. The FDA created the product code for this device type when it granted the De Novo request in March 2021; four 510(k) clearances since then have added tablets, split rooms, a 12-and-over population, a wider breathing-rate range and 24-hour trends.

Other

SANSA HSAT

Huxley Medical

FDA

Single chest-worn patch for home or in-clinic sleep apnoea testing. A reflective pulse oximeter, a single-lead ECG and a three-axis accelerometer feed a cloud algorithm that combines signal processing with machine-learning classifiers to produce an autoscored apnoea- hypopnoea index (sAHI), a central-event index (sAHIc), total sleep time and wake/REM/non-REM staging. The ECG trace is stored for a clinician to read by hand; the device performs no automated ECG analysis. Four FDA clearances between July 2024 and December 2025 built the current indication step by step: the test itself, cellular upload, the diagnostic ECG channel, and the central-apnoea and REM classifiers.

Other

Gastric Alimetry

Alimetry, Ltd.

FDA

Gastric Alimetry records the stomach's slow-wave electrical activity from the skin through a stretchable 64-electrode array worn over the abdomen, before and for four hours after a standard meal, while the patient logs symptoms in a validated app. Software removes movement and noise artefacts (a convolutional neural network since the December 2025 clearance), computes spectral metrics against published reference intervals, and pairs them with the symptom timeline in a clinician report. The FDA indication is an aid in the diagnosis of various gastric disorders in patients aged 12 and over; the published evidence covers chronic nausea and vomiting syndromes, gastroparesis and functional dyspepsia. The device measures and phenotypes. The diagnosis remains the clinician's.

Other

CephX3D

Orca Dental AI, Ltd.

Editorial summaryOther

SurgiCount+ System

Stryker Instruments

Editorial summaryOther

Personalized Therapy Comfort Settings (PTCS)

ResMed Corp

Editorial summaryOther

Triton System

GAUSS SURGICAL INC.

Sourced from FDA AI listOther

WellDoc BlueStar

WellDoc, Inc.

Sourced from FDA AI list

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