FDA Radiology AI Devices

The iBSM is a wireless patient monitoring system designed for hospital use on non-critical patients aged 18 and older. It continuously displays vital signs such as ECG waveforms, heart rate, respiratory rate, oxygen saturation, and blood pressure using biocompatible sensors. It aids clinicians by providing real-time physiological data, visual and audio alarms, and patient orientation notifications to help prevent complications like pressure ulcers.

The UbiqVue 2A Multi-parameter System is a wireless wearable biosensor system for continuous monitoring of vital signs such as ECG, heart rate, respiration, temperature, SpO2, and blood pressure (optional). It transmits data wirelessly to a central server for storage, display, and analysis, enabling healthcare professionals to remotely monitor multiple patients at home and in clinical settings with alert notifications and visual alarms for abnormal physiologic parameters.

The Rooti Rx System is a wearable single-lead ECG recording device that allows patients to record ECG data at home or work. The data is stored on the device and later transmitted via Wi-Fi to medical professionals’ iOS devices for post-analysis, aiding clinicians in patient cardiac monitoring and diagnosis.