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Home » Topics » Medical devices » Digital health

Digital health
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Businessman and IPO virtual screen

Hinge Health rings NYSE bell as IPO raises $437M

May 22, 2025
By Annette Boyle
Hinge Health Inc.’s flexibility produced big rewards as the digital therapy company for physical rehabilitation finally began trading on the NYSE under the symbol HNGE on May 22 after delaying its IPO twice. Hinge co-founders Daniel Perez and Gabriel Mecklenburg rang the opening bell for the stock exchange to celebrate the offering’s $437 million haul.
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Kakao Pasta app

Kakao Healthcare brings CGM app to Japan

May 16, 2025
By Marian (YoonJee) Chu
Step aside, Marco Polo: Kakao Healthcare Corp. plans to bring PASTA to Japan. PASTA is Kakao's AI-based continuous glucose monitoring (CGM) management mobile application, which will be available in Japan through a new subsidiary as the health care company works to expand its global presence.  
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urine testing device
Patents

Urine-testing device turns toilets into health trackers

May 16, 2025
By Simon Kerton
In what represents just the company’s third PCT filing, Houston-based Starling Medical Inc.’s co-founders, Hannah McKenney and William Hendricks, seek to gain further protection for their at-home urine diagnostic patient-monitoring platform that eliminates the traditional use of catching containers and dipsticks.
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Ribbons of digital data

Survey says AI must overcome trust issue to transform health care

May 15, 2025
By Holland Johnson
Royal Philips NV unveiled its Future Health Index report for 2025, and it reveals the widening trust gap between health care professionals and patients concerning the adoption of AI in health care.
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Businessman and IPO virtual screen

Three med-tech IPOs on the horizon

May 13, 2025
By Annette Boyle
April may not have brought rain to med-tech, but tariffs and financial uncertainty certainly dampened the enthusiasm for IPOs. With those clouds lifting, three companies – Hinge Health Inc., Capsovision Inc., and Omada Health Inc. – appear ready to flower in May, potentially a harbinger of a return to the brisk pace for med-tech IPOs seen in the opening weeks of 2025 when eight companies raised nearly $1 billion.
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Brain waves

NICE sees room for digital health for chronic tics and Tourette

May 12, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) endorsed the use of the Orbit system by Mindtech Ltd. as a treatment for tics and Tourette syndrome.
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Handshake with digital globe overlay

Med-tech financings and guidance strong despite tariffs

May 5, 2025
By Annette Boyle
April data and first quarter earnings reports show remarkable resilience in med tech, even as other sectors continue to suffer in response to tariffs and changing regulations. Not that tariffs proved insignificant: several companies reported annualized impacts north of half a billion dollars, but fundamentals and increased interest in med tech as a haven gave most players sufficient breathing room to absorb the impact with minimal adjustments.
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voinosis
Patents

Voinosis uses AI and voice analytics for early dementia diagnosis

April 30, 2025
By Simon Kerton
Seoul, South Korea-based Voinosis Co. Ltd. filed for potential worldwide protection of its AI-based system that allows for the early detection cognitive impairment, dementia, Alzheimer’s disease and hearing loss through voice analysis.
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Gears with regulatory words

Advamed AI policy document criticizes FDA’s AI PCCP guidance

April 23, 2025
By Mark McCarty
The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.
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Illustration of human body composed of molecules

Device makers wary of FDA guidance for AI-enabled software functions

April 21, 2025
By Mark McCarty
The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.
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