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BioWorld - Monday, March 2, 2026
Home » Topics » Medical devices » Digital health

Digital health
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AI silhouette

Bioplus Interphex Korea: Novartis optimistic about future with AI

Sep. 25, 2020
By Gina Lee
HONG KONG – Novartis AG was cited during the recent 2020 KoNECT-MOHW-MFDS International Conference as an example of a biopharma firm staying ahead of the artificial intelligence curve. During this week’s 2020 Bioplus Interphex Korea conference, Won Kim, head of innovation at Novartis Korea, described some of the firm’s latest forays into AI, including negotiations with potential partners to develop an AI image analysis solution for retinal diseases.
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Person wearing mask pointing at globe

Biopharm America: Non-parochial spirit ‘bright spot’ in dismal times

Sep. 24, 2020
By Randy Osborne
As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era.
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In the clinic for Sept. 24, 2020

Sep. 24, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 2Morrow, Nucleix, Rarecells Diagnostics.
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Brain clay model

Cognoa moves ahead on FDA clearance of digital autism diagnostic

Sep. 24, 2020
By Meg Bryant
Children with autism spectrum disorder (ASD) can face a lifetime of frustration because of challenges with communication, social behaviors and flexibility of thought. Early intervention can improve outcomes, but nailing a diagnosis of ASD often takes years. Cognoa Inc. wants to change that with its digital ASD Diagnostic and is on track to apply for U.S. FDA clearance before the end of the year.
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Graph of COVID-19 patient outcome trajectories

Who lives, who dies: Two leading health systems provide mortality calculators for COVID-19

Sep. 23, 2020
By Annette Boyle
Two studies seek to answer the most pressing question for physicians examining a patient with COVID-19: What's this person's risk of death? Mount Sinai researchers presented their clinical prediction model in The Lancet Digital Health and a team from Johns Hopkins published their risk calculator in the Annals of Internal Medicine.
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South Korean flag on building
2020 Bioplus Interphex Korea Conference

Vuno aims for Kosdaq listing by early 2021

Sep. 23, 2020
By Gina Lee
HONG KONG – Seoul, South Korea-based Vuno Inc. reported that it plans to list on South Korea’s Kosdaq bourse either by the end of 2020 or early next year, CTO and cofounder Kyu-hwan Jung told the 2020 Bioplus Interphex Korea Conference. After receiving A ratings in the recent technology evaluations by assessment institutions NICE D&B and Korea Enterprise Data, Vuno submitted a preliminary examination application to the bourse on July 28 that is currently underway, the company said.
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Person wearing mask pointing at globe

Biopharm America: Non-parochial spirit ‘bright spot’ in dismal times

Sep. 23, 2020
By Randy Osborne
As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era.
Read More
Reset/Reset-O homescreen on mobile phone

Coverage for Pear Therapeutics’ PDTs continues to grow

Sep. 22, 2020
By Annette Boyle
Pear Therapeutics Inc. has seen its efforts in the prescription digital therapeutics (PDT) space come to fruition with two new deals reported this week. The Hartford Financial Services Group Inc. now covers two of the company's therapeutics – Reset, for substance use disorder, and Reset-O, for opioid use disorder – for its employees and their beneficiaries. Preferredone will also cover the two PDTs for all its members.
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Regulatory front for Sept. 22, 2020

Sep. 22, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ambulatory Surgical Center Association, Dyansys, Neurosurgical Care.
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Artificial intelligence and digital health icons
The Virtual Medtech Conference

Health Canada making use of ‘regulatory sandbox’ to address AI

Sep. 21, 2020
By Mark McCarty
The field of artificial intelligence (AI) is stretching the boundaries of conventional med-tech regulation, and several regulatory agencies are working to cut that Gordian knot. Marc Lamoureaux, director of digital health at Health Canada’s (HC) medical device directorate, said on a Sept. 21 webinar that legislation passed in 2019 gives the agency a “regulatory sandbox” in which to experiment with AI regulation, a mechanism he said may bring these algorithms to market much more rapidly than would otherwise be the case.
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