SINGAPORE, Dec. 7, 2025 /PRNewswire/ — AI/ML 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.
WHY IT MATTERS
“Current early-warning scores that rely on threshold-based methods often suffer from low precision, leading to a high number of alarms and notifications. Advanced AI-driven machine learning models have the potential to deliver significantly greater precision, reducing unnecessary alerts/notifications, thus enabling healthcare professionals to better focus their time on delivering quality patient care,” said Dr. Gurpreet Singh, CEO and Founder of Respiree.
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.
With the HSA approval for the 1Bio™AI-Acute toolbox, Respiree is now setting its sights on expanding the 1Bio™AI-Acute regulatory approvals across other APAC and ANZ regions, as well as in the United States, in the coming months.
HSA’s approval of the 1Bio™AI-Acute toolbox follows the validation study that was recently peer-reviewed and published in the Mayo Clinic Proceedings.
About Respiree
Respiree™ is an AI/ML health tech company building clinically-validated AI for managing disease progression. Respiree™ products are CE marked and has received regulatory clearances from the Therapeutic Goods Administration and the United States Food and Drug Administration (FDA).
SOURCE Respiree
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