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BioWorld - Friday, January 16, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Software screenshots

I-O Urology introduces remote digital diagnostic platform for urologic care

March 11, 2021
By Annette Boyle
I-O Urology Corp. launched its Carepath platform to provide remote patient monitoring for urologic conditions. The platform uses a compact portable system to capture real-time urine voiding data and a mobile app to facilitate accurate reporting and timely communication between patients and their health care providers.
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Illustration of intestines overlayed on human torso

Mahana granted CE mark for Parallel IBS digital therapeutic

March 10, 2021
By Annette Boyle
Mahana Therapeutics Inc. obtained a CE mark for Parallel, a prescription digital therapeutic device to treat irritable bowel syndrome (IBS) in conjunction with other IBS treatments. Developed by a team of U.K. psychologists, the three-month program delivers cognitive behavioral therapy (CBT) via a web-based application.
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Smartwatch on wrist next to smartphone with Empatica Care app on screen

Empatica wins CE mark for wearable-based early symptoms detection of COVID-19

March 10, 2021
By Meg Bryant
MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.
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Regulatory actions for March 10, 2021

March 10, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akesis, Breath Direct, Clew, Datar Cancer Genetics.
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Lock on digital globe illustration

Second California privacy law sets up dual enforcement entities

March 9, 2021
By Mark McCarty
In a span of a mere two years, the state of California passed two ballot initiatives dealing with privacy that promise to have an impact on digital health, the second of which created an office specifically for privacy enforcement matters. Eric Goldman, a professor of law at the Santa Clara (California) University School of Law, said on a recent webinar that the state attorney general’s office and the new California Privacy Protection Agency (CPPA) have overlapping jurisdiction, and as a consequence, companies doing business in California may find themselves at the mercy of not one, but two enforcement entities.
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3D lung segmentation

Medi-Scan’s digital tool converts ultrasound images to 3D at the point of care

March 9, 2021
By Meg Bryant
Medi-Scan Inc. has emerged from stealth mode with cloud-based software that converts the data on ultrasound analog 2D grayscale images into a digital 3D high-definition (HD) format in less than two minutes. The company is currently focusing its efforts on the heart and lungs, with the aim of providing quick, point-of-service evaluation and triaging of patients with heart disease and other conditions, including COVID-19.
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Cell-to-cell interaction as viewed through holotomography technology

KAIST continues development of 3D holotomography technology, on the back of CAR T study success

March 9, 2021
By Gina Lee
HONG KONG – The Korea Advanced Institute of Science and Technology (KAIST) is making headway with its 3D holotomography technology, which enables a more accurate and systematic way to view cell-to-cell interactions. This could be a game changer for assessing cell therapy.
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Regulatory actions for March 9, 2021

March 9, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Able Medical, Eitan Medical, Empatica, Inivata, Mahana Therapeutics, Roche.
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In the clinic for March 9, 2021

March 9, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cognito Therapeutics, Icad.
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Digital cancer cells illustration

Median developing early lung cancer detection technology

March 5, 2021
By Bernard Banga
PARIS – Median Technologies SA has unveiled a new clinical development plan for its Ibiopsy platform to provide early diagnosis of lung cancer in at-risk populations using low dose CT scans. Median executives said they hope to demonstrate the potential of deep learning in identifying lung lesions and characterizing them as malignant or benign.
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