FDA-cleared AI devices for anesthesiology 2023
2023 has 5 anesthesiology AI devices, 150% more than 2022 (2). That is 16.7% of the 30 anesthesiology devices on the FDA list, and 2.2% of all AI-device decisions dated 2023. The companies are Belun Technology Company Limited (1), Intelligent Ultrasound Limited (1), Masimo Corporation (1), Medasense Biometrics Ltd. (1), Tyto Care, Ltd. (1). The newest is Tyto Insights for Wheeze Detection from Tyto Care Ltd., decided on December 13, 2023.
Companies in 2023
By month
Product codes
All 5 devices
- Tyto Insights for Wheeze DetectionTyto Care Ltd. · Anesthesiology
- ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · Anesthesiology
- Masimo SafetyNetMasimo Corporation · Anesthesiology
- Belun Sleep System BLS-100Belun Technology Company Limited · Anesthesiology
- PMD-200Medasense Biometrics Ltd. · Anesthesiology
Frequently asked questions
How many FDA-cleared AI anesthesiology devices were there in 2023?
5 AI-enabled anesthesiology devices have a final decision dated 2023, from 5 companies.
How does 2023 compare with 2022 for AI anesthesiology devices?
2023 has 5 anesthesiology AI devices, 150% more than 2022 (2).
Which companies cleared the most AI anesthesiology devices in 2023?
Belun Technology Company Limited (1), Intelligent Ultrasound Limited (1), Masimo Corporation (1).
What was the most recent AI anesthesiology device in 2023?
Tyto Insights for Wheeze Detection from Tyto Care Ltd. (K232237), decided on December 13, 2023. Product code PHZ.
Which product codes were most common for AI anesthesiology devices in 2023?
MNR (Ventilatory Effort Recorder): 1; PHZ (Abnormal Breath Sound Device): 1; QRG (Ultrasound Guided Nerve Block Assist): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for anesthesiology 2023,” https://ai-device-radar.vercel.app/specialty/anesthesiology/2023 (FDA list through 2026-06-29).