Respiree Secures HSA Approval for AI-Driven Deterioration Detection Tool

On December 7, 2025, Respiree, an AI and machine learning health technology startup, announced that it has received approval from the Health Sciences Authority (HSA) in Singapore for its innovative 1BioTMAI-Acute software as a Class B software-as-a-medical device (SaMD). This advanced tool aims to assist healthcare professionals in identifying acute deterioration in inpatient conditions by utilizing AI-enabled machine learning models.

The 1BioTMAI-Acute system enhances the current standards of care by providing more accurate notifications related to patient deterioration. By using only bedside-recorded vital signs—namely pulse rate, respiratory rate, oxygen saturation, and systolic blood pressure—the software generates a probability score. This score indicates whether a patient may require additional monitoring due to potential acute deterioration, offering a clearer picture of their physiological state.

Improving Patient Care through Precision

Dr. Gurpreet Singh, CEO and Founder of Respiree, highlighted the importance of this technology: “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 and enabling healthcare professionals to better focus their time on delivering quality patient care.” This statement underscores the critical role that reliability plays in clinical settings.

The 1BioTMAI-Acute toolbox is accessible to healthcare providers via Respiree’s 1BioTM platform, which has also recently secured regulatory clearance along with the RS001 wearable device. Together, these tools represent a significant advancement in monitoring and managing patient health in acute care settings.

Future Expansion Plans

With the recent HSA approval, Respiree is poised to expand its regulatory efforts for the 1BioTMAI-Acute software to other regions, including areas within the APAC and ANZ markets, as well as the United States, in the upcoming months. This expansion follows a validation study that was peer-reviewed and published in the Mayo Clinic Proceedings, further establishing the credibility of the technology.

Respiree continues to position itself at the forefront of health technology innovation. With products that are also CE marked and have received clearances from the Therapeutic Goods Administration and the United States Food and Drug Administration (FDA), the company aims to enhance disease management through clinically validated AI solutions.