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510(k)

By Adam Ang | 09:16 pm | May 05, 2025
This follows the clearance for heart rate measurement on the FaceHeart mobile app in 2023.
By Adam Ang | 09:50 pm | March 06, 2025
Also, Heuron started expanding to Japan following an exclusive deal to supply its stroke imaging AI.
By Adam Ang | 02:46 am | November 16, 2023
It has also obtained its third US FDA 510(k) clearance. 
By Adam Ang | 04:06 am | July 25, 2023
It recently obtained a 510(k) clearance from the US and funding for its expansion in Southeast Asia.
By Jessica Hagen | 01:53 pm | June 13, 2023
The FDA clearance comes just three months after the company received EU MDR Class IIb certification for its configurable disease management platform.
By Adam Ang | 01:56 am | December 23, 2022
Also, Lunit signed multiple contracts this week to deliver its AI imaging software in Hong Kong, Mongolia, and Brazil.
By Adam Ang | 01:34 am | October 28, 2022
Also, Cabrini Technology is adding medical device cybersecurity to its service offerings.
By Adam Ang | 01:35 am | September 30, 2022
Also, Point Robotics from Taiwan has received a US FDA 510(k) clearance for its surgical robot system.
By Adam Ang | 02:05 am | July 01, 2022
Also, I-MED will expand its deployment of 4DMedical's lung imaging tool across its network in Australia.
By Adam Ang | 04:27 am | August 20, 2021
Also, Ujala Cygnus opens an ICU telemedicine facility in New Delhi.