Respiree’s AI-enabled 1Bio software gets HSA greenlight for acute deterioration detection

Singapore-based AI health-tech firm Respiree has secured regulatory approval from the Health Sciences Authority for its 1BioAI-Acute software as a medical device, marking a major milestone in AI-assisted inpatient monitoring across Southeast Asia.

The approval designates the 1BioAI-Acute toolbox as a Class B software-as-a-medical device (SaMD), clearing the path for deployment in clinical settings throughout Singapore. Designed to augment acute care workflows, the software uses machine learning models to detect early signs of physiological deterioration in hospitalised patients, helping clinicians intervene before complications escalate.

Unlike traditional early-warning score systems that rely on static threshold-based alerts, Respiree’s solution leverages AI to enhance diagnostic precision and reduce alarm fatigue—two longstanding pain points in modern hospital settings. This latest regulatory milestone reinforces Respiree’s position as a rising player in the AI-driven digital health ecosystem.

How does Respiree’s AI tool improve clinical alerting compared to conventional scores?

The 1BioAI-Acute platform is engineered to identify acute deterioration in patients using only four core vital signs: pulse rate, respiratory rate, oxygen saturation, and systolic blood pressure. These data points, recorded at the patient’s bedside, are fed into proprietary machine learning algorithms that generate a probability score indicating whether the patient may require additional clinical attention.

A higher score signals a stronger likelihood of deterioration, enabling medical staff to prioritise such patients for closer observation or further intervention. This approach contrasts with conventional threshold-based systems that trigger alerts when vital signs breach pre-set parameters, often leading to high false alarm rates and alert fatigue among staff.

Dr. Gurpreet Singh, founder and chief executive officer of Respiree, said that existing early-warning systems frequently deliver low precision, inundating clinicians with unnecessary alarms. In contrast, the AI-powered 1BioAI-Acute toolbox is designed to reduce false positives, sharpen clinical triage decisions, and improve overall resource allocation in busy inpatient environments.

According to Respiree, the technology is already embedded within its broader 1Bio platform, which also includes the RS001 wearable device for continuous physiological monitoring. Both the platform and wearable device have also secured regulatory clearance from the Health Sciences Authority, positioning Respiree’s full AI-enabled acute care stack for integrated clinical use.

Why HSA approval matters for Respiree’s regional and global expansion plans

The Health Sciences Authority clearance for 1BioAI-Acute is expected to serve as a launchpad for Respiree’s broader market strategy. The company has stated that it will pursue additional regulatory approvals across Asia-Pacific (APAC), Australia and New Zealand (ANZ), and the United States over the coming months.

The validation of the AI-Acute module by Singapore’s regulatory body follows a peer-reviewed study recently published in Mayo Clinic Proceedings. That study provided evidence of the tool’s clinical relevance, with emphasis on predictive accuracy, reduced false alert ratios, and ease of integration into existing clinical workflows.

For Respiree, the HSA decision adds to a growing list of regulatory milestones. Its wearable and software solutions are already CE marked in Europe and have received approval from both the United States Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA). This multi-jurisdictional acceptance is critical for medtech startups seeking to compete in an increasingly evidence-based, outcome-driven digital health environment.

With healthcare systems around the world facing staffing shortages, rising patient acuity, and mounting pressure to improve operational efficiency, AI tools like 1BioAI-Acute are increasingly viewed as potential force multipliers. Hospital administrators and investors alike are eyeing machine learning-based triage and alert systems as low-cost, scalable interventions that could enhance both patient safety and caregiver productivity.

What’s next for Respiree as it scales AI across inpatient settings?

Now armed with regulatory approval in Singapore and multiple other key markets, Respiree is expected to intensify efforts to commercialise its AI stack through institutional partnerships, healthcare pilots, and licensing models. Analysts following the digital health sector believe that software-as-a-medical-device platforms with proven clinical outcomes are likely to see heightened interest from public and private hospitals as well as integrated health networks.

Respiree’s strategy appears tightly aligned with macro trends in value-based care, especially in high-burden environments like chronic respiratory illness and post-surgical recovery. The firm’s wearable, RS001, already supports real-time physiological monitoring, and the integration of 1BioAI-Acute into that ecosystem makes it easier for hospitals to adopt a full-stack solution.

While no commercial rollout timelines have been formally announced, industry observers expect Respiree to explore partnerships with hospitals in high-density regions such as India, Indonesia, and Japan—where patient loads frequently outstrip available ICU beds and clinician bandwidth.

Respiree has not disclosed details regarding the pricing model, licensing structure, or cloud hosting capabilities for its 1BioAI-Acute offering. However, early signals suggest the firm is positioning the product as a hospital-grade augmentation tool rather than a consumer-focused wellness platform.

In addition to geographic expansion, Respiree may also aim to evolve its AI models into predictive engines for chronic condition progression, such as COPD and heart failure. Such evolution would align with broader market interest in predictive analytics as a service (PAaaS) in healthcare, particularly among governments investing in AI infrastructure and smart hospitals.

How are institutional investors evaluating Respiree’s regulatory momentum and its chances of scaling AI-enabled inpatient monitoring across global healthcare markets

Respiree is currently privately held and has not disclosed its investor roster or funding stage. However, its growing portfolio of regulatory approvals and academic validations points to a well-structured clinical R&D foundation. Analysts tracking the health technology space suggest that companies like Respiree may attract strategic interest from medtech conglomerates or digital health roll-up vehicles seeking to expand AI-enabled offerings in high-volume care environments.

With interest in regulatory-cleared AI platforms rising across Asia-Pacific, Respiree’s timing appears favourable. As governments across the region push to integrate artificial intelligence into healthcare delivery frameworks—especially in response to pandemic-era bottlenecks and rising non-communicable disease burdens—AI tools that directly support inpatient workflows stand to gain outsized traction.

For Singapore in particular, the HSA approval underscores the country’s ambition to become a regulatory and innovation hub for digital health. The nation’s growing pipeline of AI-enabled SaMD approvals reflects a broader confidence in software-led care delivery models.

If Respiree’s 1BioAI-Acute platform performs well in early deployments, it could pave the way for a wave of similar approvals in other AI-driven physiological monitoring tools targeting early intervention and patient risk stratification.

What are the key takeaways from Respiree’s HSA approval for 1BioAI-Acute?

• Respiree has received Health Sciences Authority clearance in Singapore for its AI-enabled 1BioAI-Acute software as a Class B medical device.
• The tool uses bedside-recorded vital signs and machine learning to detect potential inpatient deterioration more accurately than threshold-based systems.
• This approval adds to Respiree’s previous regulatory wins for its wearable device (RS001) and 1Bio platform, enabling a full-stack AI monitoring solution.
• Respiree aims to expand its regulatory footprint across APAC, ANZ, and the United States following the Singapore milestone.
• Analysts expect institutional interest to rise, especially as hospital systems seek efficient ways to manage patient risk and staffing challenges.