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BioWorld - Wednesday, March 4, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Regulatory actions for Dec. 15, 2020

Dec. 15, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Anitoa, Binx Health, Ellume, Exero Medical, Genetesis, Horiba, Roche, Seaspine, Switch Health.
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Mobile app screenshot

Sanguina launches app to detect anemia

Dec. 14, 2020
By Annette Boyle
It might not have helped Iron Man survive use of the Infinity gauntlet, but for individuals with chronically iron-poor blood, Sanguina Inc. ’s new mobile app could be a lifesaver. Atlanta-based Sanguina released Anemocheck Mobile, an app that measures hemoglobin levels, for the Google Play Store and will shortly add the app for iOS. Anemocheck analyzes a photo of the user's fingernail beds and provides the hemoglobin level on the screen. Hemoglobin levels provide the most common measure of anemia.
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Rocket launch illustration

Digital solutions, convergence debates hot topics at Phar-East 2020

Dec. 14, 2020
By David Ho
HONG KONG – Big pharma and venture capital firms are increasingly focused on early-stage companies and digital solutions, judging by the interest shown by participants at Phar-East 2020. Much of the talk during the third and final day of the virtual conference that started Dec. 8 was focused on the business side of the health care space, and the undertones were definitely bullish.
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Other news to note for Dec. 14, 2020

Dec. 14, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Activepure Technologies, Aditx Therapeutics, American Bio Medica, Ashvattha Therapeutics, Babylon Health, Builtspace, Diabeloop, Efemoral Medical, Eurofins Technologies, GE Healthcare, Hummingbird Bioscience, Insightec, Lifescan, Luminultra, Mymedbot, Novacyt, Novocure, Oncimmune, Pacific Biosciences, Roche, SonALAsense, Tempus Labs, Todos Medical, Variscite, Welldoc.
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X-ray scans with highlighted regions

Partners collaborate with Boston Children’s Hospital on ‘explainable’ AI-driven technology

Dec. 11, 2020
By David Godkin
TORONTO – Waterloo, Ontario-based DarwinAI Corp. and Raleigh, N.C.-based Red Hat Inc.are developing a suite of deep neural networks for COVID-19 detection and risk stratification via chest radiography in cooperation with Boston Children’s Hospital. DarwinAI designed COVID-Net as “explainable” artificial intelligence (AI) that illuminates the inner workings of AI-driven medical technologies and promptly offered it on an open-source platform for the broader hospital community.
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Laptop, stethoscope, medical icons, health professional

FDA’s digital health checklist for 2021 crammed full of delayed priorities

Dec. 10, 2020
By Mark McCarty
The COVID-19 pandemic has been more than just a distraction for the U.S. FDA, which started 2020 with a number of ambitions regarding digital health regulation. Despite having unveiled the Digital Health Center of Excellence to great fanfare, the agency is struggling to wrap up major digital health programs, such as the precertification program for software as a medical device, leaving the FDA with a daunting agenda for digital health in the coming year.
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Freespira tablet, sensor and app

Mahana, Freespira ride wave of prescription digital therapeutics

Dec. 9, 2020
By Annette Boyle
The rising tide of digital therapeutics approved and funded in the U.S. raised the outlook for Mahana Therapeutics Inc. and Freespira Inc. as both companies announced good news. Mahana's prescription digital therapeutic for gastrointestinal conditions, Parallel, received premarket authorization from the U.S. FDA and Freespira, formerly Palo Alto Health Sciences Inc., raised $10 million for its digital therapeutic for panic attacks, panic disorder and post-traumatic stress disorder.
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Head filled with digital data

Phar-East 2020 virtual conference looks at tech and transformation

Dec. 9, 2020
By David Ho
HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and new devices are developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8.
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Software screenshot

Paige obtains CE marks for breast, prostate cancer options

Dec. 9, 2020
By Liz Hollis
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
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Cyber eye illustration

Retinai partners with Novartis for use of AI in ophthalmology trials

Dec. 8, 2020
By Nuala Moran
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).
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