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BioWorld - Tuesday, February 3, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Nuralogix Anura Magic Mirror

Magicmirror on the wall, who’s the healthiest of them all?

March 18, 2025
By Annette Boyle
Nuralogix Corp.’s Anura Magicmirror seeks to answer questions more important than relative beauty with health insights gained via transdermal optical imaging technology and AI-powered insights into more than 100 health metrics. If Snow White’s stepmother had possessed one, she might have realized that she wasn’t thinking clearly because of mental stress or low blood sugar levels and eaten an unpoisoned apple herself.
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NHS building

New AI fall prediction tool being rolled out across the NHS

March 7, 2025
By Shani Alexander
The U.K.’s national health service (NHS) is rolling out a new artificial intelligence (AI)-powered tool which can predict a patient’s risk of falling with a 97% accuracy rate. The AI software designed by Cera Care Ltd. is already in use in more than two-thirds of NHS integrated care systems across the country and NHS England hopes that the tool will prevent around 2,000 falls and hospital admissions each day.
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Close-up of nasal drug spraying

Aspargo Companion can spray most meds, alert to missed doses

March 5, 2025
By Annette Boyle
In an advance that could significantly lighten the load for caretakers in the “sandwich generation” and reduce loneliness in elderly patients, Aspargo Labs Inc. developed a metered delivery device that optimizes absorption of pharmaceuticals and reminds users to take their medications.
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Close-up of nasal drug spraying

Aspargo Companion can spray most meds, alert to missed doses

March 4, 2025
By Annette Boyle
In an advance that could significantly lighten the load for caretakers in the “sandwich generation” and reduce loneliness in elderly patients, Aspargo Labs Inc. developed a metered delivery device that optimizes absorption of pharmaceuticals and reminds users to take their medications.
Read More
Tug-of-war illustration

Novelty of PCCP filings a source of drag for FDA, industry

Feb. 28, 2025
By Mark McCarty
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
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Woman holding display of business, regulatory icons

Little interest shown in premarket use of MDSAP audits

Feb. 27, 2025
By Mark McCarty
A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.
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U.S. Capitol building, Washington D.C.

FDA’s LDT rule, CDS guidance combine to complicate regulatory life

Feb. 26, 2025
By Mark McCarty
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
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Kyorin Hyfe

Kyorin drafts deals for chronic cough DTx, loss of smell therapy

Feb. 25, 2025
By Marian (YoonJee) Chu
Kyorin Pharmaceutical Co. Ltd. struck two licensing deals recently, including one with Hyfe Inc. Feb. 25 to develop the world’s potential first prescription digital therapeutic for chronic cough in Japan.
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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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