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BioWorld - Tuesday, January 27, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Regulatory front

Japan defines path for COVID-19 vaccines

Oct. 12, 2020
By Mari Serebrov and Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.
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Woman using smartphone

Belong.Life matches cancer and MS patients to clinical trials with mobile app

Oct. 9, 2020
By Annette Boyle
Belong.Life has expanded its digital clinical trial matching program to include patients with multiple sclerosis (MS). The technology uses advanced artificial intelligence (AI) that processes a patient's medical data and determines which trials in its global database are appropriate. The app typically returns results, which are prescreened by a clinical trial coordinator, in less than two days. More than 8,000 cancer patients have used the program so far.
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Business pipeline illustration
Virtual Medtech Conference

Pandemic silver linings: ‘Future-proofed’ supply chains, digital growth, patient-controlled care accelerate

Oct. 8, 2020
By Annette Boyle
COVID-19 stalled clinical trials, halted elective surgeries, and body slammed many med-tech companies’ revenues. Despite that, an industry report released by Ernst & Young (EY) finds that the pandemic also drove some positive changes in the med-tech industry including long-neglected attention to enterprise-wide business continuity.
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Cybersecurity data lock
The Food and Drug Law Institute Annual Conference

FDA eyes 2021 for reissue of Oct. 2018 premarket cybersecurity draft guidance

Oct. 8, 2020
By Mark McCarty
There are some U.S. FDA work items that have been hampered primarily by the COVID-19 pandemic, and some that have just proven difficult to push across the finish line. The FDA’s October 2018 draft guidance for premarket considerations for cybersecurity in medical devices might fall into that latter category, but the FDA’s Suzanne Schwartz said the agency will reissue another draft version of that guidance, which will be available sometime in early 2021.
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Health, medical icons
2020 Medical Innovation Summit

Smartphone-connected pacemaker devices, experimental gene therapy among top 10 innovations at annual event

Oct. 6, 2020
By Liz Hollis
As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation.
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Illustration of business bar chart being toppled by coronavirus
Virtual Medtech Conference

Pandemic drives lasting changes in med-tech industry

Oct. 6, 2020
By Annette Boyle
COVID-19 has prompted dramatic rethinking of supply chains, health care delivery, regulations, and collaboration that are likely to permanently restructure the med-tech industry, according to industry leaders speaking at a panel during the Advanced Medical Technology Association’s (Advamed) Virtual Medtech Conference on Oct. 6. In addition, the significant increase in debt and strong fundamentals position the industry for a burst of M&A activity.
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Regulatory front

Stakeholders sound off on Medicare doc fee, outpatient drafts

Oct. 6, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Other news to note for Oct. 6, 2020

Oct. 6, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, 1Health.io, Abbott Laboratories, Biologica Technologies, Clear, Diagnostic Robotics, Emanate Wireless, Genentech, Imbio, Ion Beam Applications, Iprocedures, Medshape, Mesuron, Mgroup, Neupath Health, Opum US, Pharmajet, Pivot Design Group, Qiagen, Quanterix, Quest Diagnostics, Readcoor, Sanara Medtech, Shin-Ho Instruments, Tyber Medical, Vizient, Xtant Medical.
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Ribbons of digital data
Anesthesiology 2020 annual meeting

AI machine learning could help tailor opioid treatment, reduce addiction risk

Oct. 5, 2020
By Mary Ellen Schneider
An artificial intelligence machine learning model that mines electronic health record data could help physicians fight the opioid epidemic by targeting non-opioid pain treatments to patients experiencing severe pain after surgery, according to new research presented at the Anesthesiology 2020 annual meeting.
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Coronavirus, question marks
Virtual Medtech Conference

Industry reflects on the future of innovation as COVID-19 continues to have an impact

Oct. 5, 2020
By Liz Hollis
What is the future of med-tech innovation in the wake of COVID-19? That was the question addressed during the Advanced Medical Technology Association’s Virtual Medtech Conference, with members of industry providing some insight. “I think … that this is going to be in many ways a turning point,” changing the way stakeholders look at devices and the evidence supporting them, said Tom O’Brien, of Johnson & Johnson’s (J&J) Ethicon unit.
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