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BioWorld - Thursday, February 5, 2026
Home » Topics » Medical devices » Digital health

Digital health
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FDA icons

Stakeholders keen on regulatory clarity with emergence of FDA digital center

Oct. 19, 2020
By Mark McCarty
The news that the U.S. FDA has opened a new digital health office carries some significant expectations for stakeholders, expectations that may take time to meet. More than one participant in the Oct. 19 FDA listening session for the Digital Health Center of Excellence (DHCoE) called on the FDA to ensure that this new center provides more regulatory clarity regarding a number of products, a task that may be some time in coming, given the need to harmonize with other national and international regulatory entities.
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Coronavirus, lungs, hand holding stethoscope

Nec partners with Oslo University Hospital to develop AI-based diagnostic for COVID-19

Oct. 16, 2020
By Elise Mak
Nec Corp.’s bioinformatics subsidiary Nec Oncoimmunity AS said it is working with Oslo University Hospital to develop an artificial intelligence (AI) platform that will allow the team to design a T-cell diagnostic to complement the current serological tests for infectious diseases, including COVID-19.
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Regulatory actions for Oct. 15, 2020

Oct. 15, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Livmor, Sanuwave, See-Mode Technologies.
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Australia and coronavirus

Australia’s device and biotech companies hold the key for future pandemic preparedness: MTPConnect report

Oct. 15, 2020
By Tamra Sami
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
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Remote patient monitoring concept illustration

Remote monitoring played critical role in managing pandemic surge

Oct. 14, 2020
By Annette Boyle
As hospitals faced a deluge of patients early in the COVID-19 pandemic, many implemented remote solutions to manage individuals at home to keep from being overwhelmed – all at a speed unthinkable in more normal times. That experience promises to accelerate and transform telemedicine long after the threat of COVID-19 recedes, according to a report by Vizient Inc.
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Health professional touching screen, digital/medical icons

UK Bioscience Forum: COVID-19 amplifying importance of real world data

Oct. 14, 2020
By Nuala Moran
Tracking the pandemic in all its manifestations – from symptoms and spread, to viral genomics and repurposing drugs – has massively increased appreciation of the importance of real world data, with significant implications for the future of drug discovery and clinical development, the use of patient data and health care as a whole.
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Tytohome device and mobile app
HLTH VRTL 2020

Tyto Care takes telehealth to telediagnosis

Oct. 13, 2020
By Annette Boyle
Over the last seven months, the pandemic starkly illuminated both the tremendous potential and the significant limitations of telehealth today. Tyto Care Ltd. benefited tremendously from the increase in physician visits using its proprietary all-in-one modular device and examination platform as patients tried to avoid exposure to the novel coronavirus. It also recognized the opportunity to improve the quality of remote interactions with artificial intelligence (AI).
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Map, flag of India

COVID-19 pandemic fuels India’s telemedicine growth

Oct. 12, 2020
By T.V. Padma
NEW DELHI – India’s digital health market is poised to grow rapidly over the next five years propelled by the COVID-19 pandemic, according to two new reports.
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Software analysis of chest CT scans
AI solution for prognosis of COVID-19 pneumonia

Therapanacea develops AI solution to quantify the severity of lung damage from COVID-19

Oct. 12, 2020
By Bernard Banga
PARIS – A consortium that includes Therapanacea SAS, GE Healthcare France SAS, Orange Healthcare SA, the AP-HP group of 39 hospitals in the Paris region and the French academic society for thoracic imaging has created a database for COVID-19.
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Regulatory actions for Oct. 12, 2020

Oct. 12, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cartiheal, GE Healthcare, Varian.
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