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Home » Topics » Medical devices » Digital health

Digital health
Digital health RSS Feed RSS

Globe showing Asia-Pacific region
Year in review

Asia Pacific remains fastest growing market for medtech

Dec. 24, 2024
By Tamra Sami
The Asia Pacific med-tech industry is expected to grow to $225 billion by 2030. Despite that rosy outlook, the landscape become increasingly challenging as med-tech investment saw a notable downturn since its peak in 2021, with venture financing and M&A deals decreasing by 22% and 37%, respectively, over the past two years.
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Acryl

Acryl cleared as Korea’s first AI DTx to screen, diagnose depression

Dec. 23, 2024
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.
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Promise Bio founders
Immune

Promise Bio raises $8.3M for immune-mediated diseases platform

Dec. 19, 2024
By Shani Alexander
Promise Bio Ltd. emerged from stealth with $8.3 million in seed investment for its precision medicine platform, which addresses immune-mediated diseases. The funding will be used to accelerate the development of the company’s technology that analyzes proteins and their post-translational modifications to predict the treatment responses of patients with immune-mediated diseases.
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Promise Bio founders

Promise Bio raises $8.3M for immune-mediated diseases platform

Dec. 18, 2024
By Shani Alexander
Promise Bio Ltd. emerged from stealth with $8.3 million in seed investment for its precision medicine platform, which addresses immune-mediated diseases. The funding will be used to accelerate the development of the company’s technology that analyzes proteins and their post-translational modifications to predict the treatment responses of patients with immune-mediated diseases.
Read More
Promise Bio founders

Promise Bio raises $8.3M for immune-mediated diseases platform

Dec. 17, 2024
By Shani Alexander
Promise Bio Ltd. emerged from stealth with $8.3 million in seed investment for its precision medicine platform, which addresses immune-mediated diseases.
Read More
U.S. FDA headquarters

FDA’s AI PCCP final guidance relaxes indication for use restrictions

Dec. 9, 2024
By Mark McCarty
The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial changes, some more significant than others.
Read More
Mammogram

Mica AI looking to transform early breast cancer diagnosis

Dec. 3, 2024
By Shani Alexander
Mica AI Medical Ltd. is looking to transform the early diagnosis of breast cancer with its software which helps radiologists analyze mammograms more effectively. The company recently signed a collaboration and licensing agreement with Baptist Health South Florida in a bid to bring its technology to the U.S. market.
Read More
Evie Ring - Movano

Movano rings up FDA pulse ox clearance for Eviemed

Dec. 2, 2024
By Annette Boyle
Movano Inc., dba Movano Health, added some clinical-grade glitz to its Evie ring with a U.S. FDA clearance for the built-in pulse oximeter. Movan’s stock shot up from an all-time low within minutes of the announcement on Dec. 2, as the clearance breathes new life into Movano’s plans to position the ring as a medical device.
Read More
Ribbons of digital data

Hazards of prompt engineering a concern for regulation of GenAI

Nov. 26, 2024
By Mark McCarty
The health care potential for generative artificial intelligence comes with hazards such as the inadvertent effects of poor prompt engineering practices, but Anil Bhatta of Deloitte Consulting told a U.S. FDA advisory committee that this risk could be managed by rules that would thwart any consequent problems, such as an inadvertent jailbreak of the algorithm’s intended use.
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Female sitting on floor in dark room

Trivarx’s AI-based algorithm provides objective depression diagnosis

Nov. 26, 2024
By Tamra Sami
Diagnosing depression and other mental illnesses is largely subjective, but that could soon change as Sydney-based Trivarx Ltd. developed an AI-based algorithm that uses heart rate and heart rate variability coupled with sleep disturbance to diagnose major depressive episodes.
Read More
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