Respiree Gains Approval for AI Tool to Detect Patient Deterioration

On December 7, 2025, Respiree, an AI and machine learning health-tech startup, announced that it has received approval from the Health Sciences Authority (HSA) in Singapore for its innovative 1BioTMAI-Acute toolbox. This software, classified as a Class B software-as-a-medical-device (SaMD), is designed to assist healthcare professionals in detecting acute deterioration in hospitalized patients.

Enhanced Detection Using AI Technology

The 1BioTMAI-Acute toolbox leverages advanced AI-enabled machine learning models to provide healthcare professionals with a more accurate method of monitoring patients. Unlike traditional early-warning systems that often rely on threshold-based methods, which can generate a high volume of false alerts, the 1BioTMAI-Acute system delivers significantly improved precision. This advancement allows for fewer unnecessary notifications, enabling clinicians to concentrate on delivering quality care.

Using only bedside-recorded vital signs—such as pulse rate, respiratory rate, oxygen saturation, and systolic blood pressure—the system generates a probability score. This score indicates a patient’s general physiological state, with higher scores suggesting an increased likelihood of deterioration requiring further monitoring.

“Current early-warning scores that rely on threshold-based methods often suffer from low precision, leading to a high number of alarms and notifications,” said Dr. Gurpreet Singh, CEO and Founder of Respiree. “Advanced AI-driven machine learning models have the potential to deliver significantly greater precision, reducing unnecessary alerts, thus enabling healthcare professionals to better focus their time on delivering quality patient care.”

Future Plans and Regulatory Expansion

The 1BioTMAI-Acute toolbox is now available to healthcare professionals through Respiree’s 1BioTM platform, which also recently obtained regulatory clearance along with the RS001 wearable device. With this achievement, all components—including the 1BioTMAI-Acute toolbox, the 1BioTM platform, and the RS001 wearable—are endorsed by the HSA.

Following this critical milestone, Respiree is planning to expand its regulatory approvals for the 1BioTMAI-Acute toolbox into other regions, including Asia-Pacific (APAC), Australia-New Zealand (ANZ), and the United States in the upcoming months. This expansion aims to enhance patient care on a wider scale.

The HSA’s approval aligns with the findings of a validation study recently published in the Mayo Clinic Proceedings, which underscores the efficacy of the technology in clinical settings.

Respiree is committed to advancing healthcare through clinically validated AI solutions that effectively manage disease progression. The company’s products are not only CE marked but also have received regulatory clearances from the Therapeutic Goods Administration and the United States Food and Drug Administration (FDA).