Respiree plans to broaden regulatory approvals for its 1Bio AI-Acute toolbox across APAC, ANZ, and the United States, building on the current HSA clearance.

The HSA clearance complements prior approvals of the 1Bio platform and the RS001 wearable, resulting in full approval of the 1Bio AI-Acute toolbox, platform, and RS001 wearable.

The awards recognize financial soundness, operational efficiency, product excellence, leadership, and market success in the global semiconductor sector.

A peer‑reviewed validation study published in Mayo Clinic Proceedings underscores the model’s validation and clinical relevance.

Executives emphasized SK hynix’s continued push for technological competitiveness and value creation as it accelerates its AI memory roadmap.

Singapore’s HSA approved Respiree’s 1Bio AI-Acute toolbox as a Class B SaMD to assist in detecting acute inpatient deterioration using AI models based on bedside vital signs.

Compared with current threshold-based early warning scores, the AI-driven model offers higher precision, reducing false alarms and enhancing patient care.

Investments in AI memory and HBM production facilities reinforce SK hynix’s leadership in AI memory.

Respiree states its products carry CE marking and regulatory clearances from TGA and the U.S. FDA, with ongoing regulatory clearance in additional jurisdictions.

Respiree’s regulatory status includes CE marking, TGA clearance in Australia, and FDA clearance in the U.S., aligning with its mission to deliver clinically validated AI solutions for disease progression management.

For 2025 year-to-date, SK hynix reported revenue of 64 trillion won, operating profit of 28 trillion won, and cash reserves of 27.9 trillion won, moving toward a net cash position.

Respiree CEO Dr. Gurpreet Singh says AI-driven models can reduce false alarms and allow clinicians to focus more on patient care by increasing notification precision.

SK hynix received two 2025 GSA Awards: Best Financially Managed Semiconductor Company (over $1B in annual sales) and Outstanding Asia-Pacific Semiconductor Company, announced on December 4, 2025.

The AI-enabled 1Bio AI-Acute system uses bedside vital signs to generate a probability score indicating the likelihood of needing additional monitoring, aiming to improve precision over traditional threshold-based scores.