Singapore-based health-tech startup Respiree has received approval from the Health Sciences Authority (HSA) for its 1Bio™AI-Acute toolbox as a Class B software-as-a-medical device (SaMD).
The solution is designed to support healthcare professionals in identifying acute inpatient deterioration using AI-enabled machine learning models. Compared to the current standard of care, 1Bio™AI-Acute delivers significantly higher precision in acute deterioration notifications, resulting in fewer false alerts and more efficient clinical support.
The 1Bio™AI-Acute system uses only bedside-recorded vital signs—pulse rate, respiratory rate, oxygen saturation, and systolic blood pressure—to generate a probability score that assists clinicians in determining whether additional monitoring may be required. This score provides an indication of the patient's general physiological state: the higher the score, the greater the likelihood that the patient may require additional monitoring due to potential acute deterioration.
The 1Bio™AI-Acute is readily available to healthcare professionals through Respiree's 1Bio™ platform, which recently received regulatory clearance together with the RS001 wearable device. With this milestone, the 1Bio™AI-Acute toolbox, the 1Bio™platform, and the RS001 wearable are all now approved by HSA.
