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Home » Topics » Medical devices » Digital health

Digital health
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European Union flag with wooden gavel

EC drops AI liability directive for now

Feb. 12, 2025
By Mark McCarty
The European Commission’s proposal for an AI-specific liability law seemed destined to pile onto existing EU liability law, but the commission reported it will pull the legislative proposal dubbed the AI Liability Directive.
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United Kingdom flag, map

NICE to revisit its cost savings approach to health tech assessment

Feb. 11, 2025
By Mark McCarty
The U.K.’s National Institute for Health and Care Excellence (NICE) historically relies on cost savings to vet novel medical technologies, but that may soon change per a Feb. 7 announcement.
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Black dollar sign on ombre blue background

Comma locks up $2M in seed funding for secure period tracker

Feb. 7, 2025
By Annette Boyle
The Comma Collective Inc. raised $2 million in a seed round to support the launch of its secure period tracker and disease detection app, Sara, and further development of its products.
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MHRA logo

MHRA offers guidance on regulated, unregulated digital health apps

Feb. 4, 2025
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency has provided guidance on what does and does not constitute a regulated digital mental health technology, but developers should be aware that promotional claims could push a product from the unregulated to the regulated category.
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Ribbons of digital data

South Korea issues world’s first generative AI medical device guideline

Feb. 4, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
Read More
Hourglass on glowing circuit board, symbolizing time and technology

California AG advisory tightens down on AI in health care

Feb. 4, 2025
By Mark McCarty
U.S. federal law is still lacking where AI is concerned, but California’s attorney general issued a bulletin that elevates the legal hazards of AI in medical use. The bulletin says that AI tools may not supplant a physician’s decision-making, a provision that would seem to render some FDA-cleared products illegal there.
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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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Parkinson's disease illustration showing neurons containing alpha-synuclein

Neu Health secures $2M to bring platform to the US

Jan. 30, 2025
By Shani Alexander
Neu Health Ltd. received $2 million in funding from Cedars-Sinai Intellectual Property Company and Oxford Science Enterprises (OSE) to bring its platform, designed for Parkinson’s disease and dementia care, into the U.S.
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Eyebright Meiyue Tong TOPPOP Smart store

‘Little giant’ Eyebright’s phakic IOL cleared for myopia in China

Jan. 30, 2025
By Marian (YoonJee) Chu
Eyebright Medical Technology (Beijing) Co. Ltd. is expanding its position in China’s phakic intraocular lens (IOL) market, gaining the National Medical Products Administration (NMPA) approval of its Loong Crystal PR phakic IOL product for myopia in adults in January 2025.
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Ribbons of digital data

South Korea issues world’s first generative AI medical device guideline

Jan. 24, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
Read More
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