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BioWorld - Thursday, January 15, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Smartphone showing One Drop app

One Drop wins CE mark for glucose prediction tool

May 14, 2021
By Meg Bryant
Information Data Systems Inc., doing business as One Drop, has earned the CE mark for its blood glucose prediction analysis engine to accurately forecast glucose levels up to eight hours in advance. The artificial intelligence (AI)-powered tool is indicated for people living with prediabetes, type 2 diabetes, including those on oral medications and/or insulin regimens, and gestational diabetes.
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Regulatory actions for May 14, 2021

May 14, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: One Drop.
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Blue heart and data grid

Ultrasight eyes $13M series B funding for cardiac ultrasound technology

May 13, 2021
By Gina Lee and David Ho
HONG KONG – Ultrasight Ltd. has closed a $13 million series B funding round, and is a step closer to entering the clinic in the U.S. with its cardiac ultrasound software. With the funds in hand, Rehovot, Israel-based Ultrasight aims to start clinical trials in the U.S. for its artificial intelligence (AI)-guided software for cardiac ultrasound.
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Digital heart illustration

Egnite aims to spark change in structural heart disease care with new predictive suite

May 12, 2021
By Annette Boyle
Egnite Inc. emerged from stealth mode in February 2021 with the goal of combining data analytics and digital health technology to illuminate and solve persistent issues in the diagnosis and treatment of structural heart disease. Three months later, it has added artificial intelligence (AI) to its flagship solution, Cardiocare, to drive better diagnosis of aortic stenosis and help physicians predict patient outcomes.
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Chinese flag and microscopes
Chinabio Partnering Forum

Multinational corporations view China as source of innovation and accelerator of digital health

May 12, 2021
By Elise Mak
Multinational players are changing the way they look at China as a source for innovation as it accelerates efforts in areas such as digital health in pursuit of desire to make a global impact. At the Chinabio Partnering Forum, panelists representing Pfizer Inc., Merck & Co. Inc., Sanofi SA and Johnson & Johnson all shared what they have witnessed there and how they’re already tapping China-sourced innovations.
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Pandemic recovery key theme of Australia’s budget with med-tech, biotech sectors praising new measures

May 12, 2021
By Tamra Sami
PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.  
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Illustration of prostate, focal ablation device

FDA fast tracks Avenda Health's prostate cancer lumpectomy technology

May 11, 2021
By Annette Boyle
Avenda Health Inc. has taken a page out of the breast cancer book with a new technology that offers very localized treatment of prostate tumors in a procedure the company refers to as a prostate cancer lumpectomy. The FDA granted breakthrough device designation to the product based on its potential to transform care for one of the most common cancers.
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Financings for May 11, 2021

May 11, 2021
Med-tech firms raising money in public or private financings, including: Caris Life Sciences, Ultrasight.
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Regulatory actions for May 11, 2021

May 11, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda Health, Whiterabbit.
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Regulatory actions for May 10, 2021

May 10, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bigfoot Biomedical, Conformis, Edge Surgical, Inova Diagnostics, Ortho Development, Orthofix, Think Surgical.
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