News from Medical Device Network
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Top Medical Device Network News

Singapore · SingaporeSINGAPORE, Dec. 7, 2025 /CNW/ -- 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…See the Story
RESPIREE SECURES SINGAPORE HSA APPROVAL FOR ITS AI-ENABLED 1BIO™AI SOFTWARE TO SUPPORT ACUTE DETERIORATION DETECTION
60% Center coverage: 5 sources
Teleflex Announces Sale of Acute Care, Interventional Urology, and OEM Businesses for $2.03 Billion - Teleflex (NYSE:TFX)
100% Center coverage: 1 sources

Artificial Intelligence · MarylandSubmission marks a key regulatory milestone toward bringing SEER-calibrated, imaging-based risk assessment to U.S. screening programs SEOUL, South Korea, Dec. 8, 2025 /PRNewswire/ — Lunit (KRX:328130), a leading provider of AI for cancer diagnostics and precision oncology, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) […]See the Story