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BioWorld - Friday, December 26, 2025
Home » Topics » Medical devices » Digital health

Digital health
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Regulatory actions for Nov. 17, 2020

Nov. 17, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Systems, Allotrope Medical, Co-Diagnostics, Hologic, Safkan, Sommetrics, Tissium.
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In the clinic for Nov. 16, 2020

Nov. 16, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cala Health, Istar Medical, Liberate Medical, Qlarity Imaging.
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Australian flag on laptop screen with health professional
Australia’s National Digital Health Initiative

Australia’s distance not a disadvantage when it comes to digital health technologies

Nov. 13, 2020
By Tamra Sami
PERTH, Australia – The COVID-19 pandemic has highlighted the importance of digital health technology, and the Australian government quickly enabled programs in telehealth and e-prescriptions. It now is embracing opportunities to build on this momentum to accelerate the country’s economic digital transformation. Not only will this transformation contribute to Australia’s recovery, but also to its long-term prosperity, said Sue MacLeman, chair of Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect), during a recent ANDHealth teleconference.
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Software screenshot

Lantheus receives clearance for AI-enabled bone scan run on GE Healthcare's Xeleris platform

Nov. 13, 2020
By Annette Boyle
The U.S. FDA granted 510(k) clearance to Lantheus Holdings Inc.'s artificial intelligence (AI)-enhanced automated bone scan index (aBSI) product for prostate cancer on GE Healthcare's Xeleris platform. ABSI improves quantification and management of disease progression in advanced prostate cancer patients.
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Regulatory actions for Nov. 13, 2020

Nov. 13, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lantheus.
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Vocal soundwave illustration

Shout out to Sonde Health for releasing voice-based health API

Nov. 12, 2020
By Annette Boyle
The competitive din in the vocal sound diagnostic space rose to new levels as Sonde Health Inc. launched a developer portal to enable other companies to incorporate its vocal biomarker-based health check technology into their apps. Sonde joins a growing number of companies and academic labs around the world talking up the ability of voice recordings to detect a surprising range of diseases.
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U.S. flag, stethoscope

Coverage, reimbursement persist as key considerations for digital health

Nov. 12, 2020
By Mark McCarty
Regulation of the digital health space is in some respects fundamentally different from traditional hardware medical devices, a fact that was highlighted during a Nov. 12 webinar hosted by the U.S. FDA. Nonetheless, several participants in the webinar made the point that the twin problems of coverage and reimbursement are critical issues for digital health as well, a problem that some see as requiring more collaboration between the FDA and the Centers for Medicare & Medicaid Services (CMS).
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Digital cancer cells illustration

Varian injects $10M in Cota to fuel data-driven cancer care

Nov. 11, 2020
By Meg Bryant
Varian Medical Systems Inc. has invested $10 million in and inked a collaboration agreement with Cota Inc., a Boston-based curator of oncology clinical data. The radiation oncology company will now offer its customers access to Cota’s oncology real-world analytics and data curation services, which aggregate electronic health record (EHR) data to yield meaningful insights.
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Illustration of mouths coughing into hands

Quick cough tests reliably ID asymptomatic COVID-19, other conditions

Nov. 10, 2020
By Annette Boyle
As cases skyrocket and more questions arise about the high rate of false negatives returned by rapid testing in COVID-19 cases, a simple, new diagnostic test offers far greater accuracy. Researchers around the globe have found that artificial intelligence can detect coronavirus infections in recorded forced coughs, with nearly 100% accuracy in asymptomatic or presymptomatic cases, making it an ideal quick screening test. Forced cough or voice analysis shows strong results in other conditions, too, including pulmonary hypertension and, surprisingly, Alzheimer's disease.
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Regulatory actions for Nov. 10, 2020

Nov. 10, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocartis, Icotec, Materialise, Medcad.
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