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BioWorld - Saturday, December 27, 2025
Home » Topics » Medical devices » Digital health

Digital health
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Signots Stelo

Signos adds AI to CGM to drive weight loss

Aug. 21, 2025
By Annette Boyle
Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.
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Apple Watch pulseox

Apple reintroduces pulseox via software update

Aug. 14, 2025
By Greg Kaplan and Annette Boyle
Some Apple Watch users will be able to monitor their blood oxygen levels through their iPhone, thanks to a software update the company planned to issue Aug. 14. The Cupertino, Calif.-based company pulled the feature from its watches in the U.S. in 2024, following a patent dispute with Masimo Corp., of Irvine, Calif., that threatened an import ban.
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PNU AI ultrasound

Research details new AI-enhanced 3D ultrasound imaging method

Aug. 11, 2025
By Marian (YoonJee) Chu
A research team from Pusan National University has developed a novel deep learning model coined Moglo-Net, designed to enable three-dimensional reconstruction of images from hand-held ultrasound procedures.
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Telehealth illustration

CMS takes aim at skin substitutes, telehealth in 2026 doc fee draft

July 15, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has pulled off the gloves when it comes to spending on skin substitutes in the draft Medicare physician fee schedule for 2026, proposing a payment methodology that would slash spending by 90%. However, the doc fee draft also proposes to simplify the process by which telehealth coverage is provided for a physician service, a move that may significantly expand the types of services that can be handled without an in-office visit.
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Lunit

Lunit, Microsoft to codevelop cloud-based clinical AI solutions

July 3, 2025
By Marian (YoonJee) Chu
Lunit Inc. reported a new collaboration with Microsoft Corp. July 2 to jointly develop medical AI programs accessible on Microsoft’s Azure cloud platform.
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MHRA logo

MHRA tackles risk classification for digital mental health tech

July 3, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as a medical device.
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Reset Moves action shot

Reset Moves to promote well-being in children with neurodivergence

June 16, 2025
By Tamra Sami
Focused on promoting well-being amongst children with neurodivergence, Reset Moves Pty Ltd. created app-based games to help children not only focus with greater clarity, but also to better help them re-engage in certain settings.
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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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