Signify Premium Insight: Keya Opens Door to US Expansion
Published: February 23, 2023
Chinese AI vendor Keya Medical recently announced that its AI-powered FFR-CT solution, DEEPVESSEL FFR is now available for clinical use in the US.
The availability follows the US-FDA clearance of the solution, and a significant clinical validation study, which was conducted at multiple international sites and on a range of patient populations.
Keya Medical is not a typical Chinese AI developer. Not only was it one of the first of the country’s vendors to receive US-FDA clearance, it is also among the world’s only vendors with regulatory approval in China (the first also to receive Class III NMPA approval), the US and Europe, and has previously acquired and integrated another US-based AI developer.
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