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SAMD
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Doctor with illustration of kidneys

MFDS clears world’s first ECG-based AI kidney disease software

June 11, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.
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Approved stamp

South Korea approves record number of biosimilars in 2024

May 6, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Approved stamp

South Korea approves record number of biosimilars in 2024

April 30, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Salix Coronary Artery

FDA clears Artrya’s AI-based coronary anatomy software

April 3, 2025
By Tamra Sami
The U.S. FDA cleared Artrya Ltd.’s Salix Coronary Anatomy software that analyzes coronary computed tomography angiogram scans via AI to better diagnose coronary artery disease.
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Gears with regulatory words

IMDRF mimics tri-agency approach to good machine learning practices

Jan. 31, 2025
By Mark McCarty
A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also supports the notion that there is no point in reinventing a highly functional regulatory wheel.
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Ayble Health
Patents

Ayble Health’s AI-enabled digital care platform for GI conditions

Jan. 31, 2025
By Simon Kerton
In what represents the first PCT filing emerging in the name of Ayble Health Inc., protection is sought for a system for adaptive, multi-level processing of health data to be used in the individualized management of immune-mediated inflammatory diseases such as inflammatory bowel disease and irritable bowel syndrome.
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BlinkLab Test

Blinklab digital app could change how autism is diagnosed

Oct. 25, 2024
By Tamra Sami
Children with autism spectrum disorder (ASD) often must wait years before they get a diagnosis, and that wait time can result in missed opportunities for changing behaviors associated with autism.
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Melanoma cells stained with an H & E stain and magnified to 320x.

AI Medi Scan develops at-home melanoma detection app

Sep. 24, 2024
By Tamra Sami
Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.
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Melanoma cells stained with an H & E stain and magnified to 320x.

AI Medi Scan develops at-home melanoma detection app

Sep. 19, 2024
By Tamra Sami
Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.
Read More
Neudive
Global Bio Conference 2024

Neudive advances game-like digital therapeutic for autism

Sep. 6, 2024
By Marian (YoonJee) Chu
Seoul, South Korea-based Neudive Inc. is advancing a game-like digital therapeutic called Buddy-in as a software solution for children and adolescents with autism spectrum disorder to practice and improve social skills.
Read More
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