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BioWorld - Wednesday, March 4, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Eye with digital overlay
Product liability and medical devices

AI presents potential for new theories of medical product liability

Aug. 26, 2024
By Mark McCarty
Product liability is always a point of concern for manufacturers of medical devices and other U.S. FDA-regulated products, and the broad contours of product liability jurisprudence are well known by corporate counsel. However, artificial intelligence products are rapidly pressing their way into routine clinical use, representing a technological shift that may occasionally deviate from the existing rules of the road where product liability is concerned.
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Rejoyn Loading Screen

Otsuka, Click launch digital therapeutic for depression

Aug. 15, 2024
By Annette Boyle
Otsuka Precision Health Inc. and Click Therapeutics Inc. pondered the signature question of cognitive behavioral therapy when setting the market approach for their jointly developed prescription digital therapeutic for major depressive disorder, Rejoyn.
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Synchron Inc Stentrode brain implant

Synchron links brain implant device to Apple Vision Pro

Aug. 2, 2024
By Tamra Sami
Neurotech startup Synchron Inc. connected its brain implant to Apple’s Vision Pro headset, enabling patients with limited physical mobility to control the device using only their thoughts. Synchron is building an endovascular brain-computer interface designed to help patients with paralysis operate technology like smartphones and computers with their minds.
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DNA with bar chart

Huma Therapeutics raises $80M in series D for growth

July 30, 2024
By Shani Alexander
The $80 million in financing that Huma Therapeutics Ltd. recently raised is a testament to where the company is and what it achieved at a time when the digital health industry is struggling to raise significant financing, Mert Aral, chief medical officer at Huma, told BioWorld.
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Art concept for gene therapy research

NIH: AI good at diagnosis, not quite ready for prime time

July 26, 2024
By Mark McCarty
Artificial intelligence might solve a world of cost issues for medical science, but the results of a recent study suggest that the day has not yet come when hospitals and doctor’s offices can just feed data into a computer and expect a reliable and intelligible diagnosis.
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Digital brain and silhouette

Authorities in EU, UK and US eye competition in AI marketplace

July 25, 2024
By Mark McCarty
Regulation of artificial intelligence for medical devices is still a developing space, but market competition authorities in the European Union, the U.K. and the U.S. are already examining the potential for anticompetitive behavior in this rapidly growing technological arena.
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Cancer cell, DNA illustration

Paige’s pan-cancer foundational model detects 16 cancer types

July 23, 2024
By Annette Boyle
Paige AI Inc.’s partnership with Microsoft Corp., announced last September, appears to have paid off quickly, with a study published in Nature Medicine demonstrating that their jointly developed image-based artificial intelligence model, Virchow, detects 16 cancer types as well or better than tissue-specific clinical-grade models.
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Elder care illustration

Australia looks to digital strategies for better elder care

July 19, 2024
By Tamra Sami
Australia’s Department of Health has released a new Aged Care Digital Strategy to increase the use of digital technology to enhance the care and wellbeing of older people in aged care facilities. By 2062, the number of people over 65 is expected to more than double, and the number of people over the age of 85 will more than triple. Australia’s aged care workforce is already under strain and will need to increase to meet this demand, a 2023 intergenerational report said.
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Seoul, South Korea

AI med-tech Airs Medical raises $20M in series C

July 12, 2024
By Marian (YoonJee) Chu
Airs Medical Inc., of Seoul, South Korea, raised $20 million in a series C financing round to expand its artificial intelligence-based health care technology, including for better and faster magnetic resonance imaging scans for radiologists and patients.
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Spectral AI Deepview system

Spectral AI collaborates with Polynovo to test wound healing device

July 12, 2024
By Tamra Sami
AI-focused medical diagnostics company Spectral AI Inc. is collaborating with burn wound therapy company Polynovo Ltd. to test limited deployment of Spectral’s Deepview system for predicting burn healing in Australia.
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