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BioWorld - Wednesday, June 17, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Ginger secures $50M to expand mental health platform solutions

Aug. 7, 2020
By Meg Bryant
On-demand mental health company Ginger.io scooped up $50 million in a series D round that was led by Advance Venture Partners and Bessemer Venture Partners. Participants also included Cigna Ventures and existing investors such as Jeff Weiner, executive chairman of Linkedin, and Kaiser Permanente Venture.
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Various screenshots of software showing retinal images

Eyenuk gets FDA nod for AI-based diabetic retinopathy screening tool

Aug. 7, 2020
By Meg Bryant
People with diabetes are at risk of developing diabetic retinopathy (DR), an eye condition that can cause vision loss and blindness. However, early detection and treatment can slow its progress. To that end, the Food and Drug Administration has cleared the way for Eyenuk Inc. to market its Eyeart autonomous artificial intelligence (AI) system for DR screening in the U.S.
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Australia map, flag

Australia’s TGA reports actual harm and potential harm caused by medical software

Aug. 6, 2020
By Tamra Sami
PERTH, Australia – A review by Australia’s Therapeutic Goods Administration (TGA) revealed that medical device recall databases may significantly under-represent software errors, causing harm to patients. These under-reported events are due to patients being unaware how to report problems, inadequate information being reported, effects of software errors being too subtle or difficult to detect, or root cause analyses that may not identify software as the source of error when it causes other components to fail.
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Physician with patient

Saykara mobile AI assistant improves practice productivity 500%

Aug. 5, 2020
By Annette Boyle
Saykara Inc.’s artificial intelligence (AI) assistant enabled the Midwest Institute for Minimally Invasive Therapies (MIMIT Health) to boost practice productivity five-fold. The voice-enabled iOS-based app, named Kara, drafts visit summaries, updates the electronic health record, produces prescriptions, and more with limited involvement from clinicians.
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Handshake dollar sign

Teladoc, Livongo to merge after striking $18.5B deal

Aug. 5, 2020
By Liz Hollis
Following Siemens Healthineers AG’s announcement that it was picking up Varian Medical Systems Inc. for $16.4 billion, another multibillion-dollar deal has emerged. This time, Teladoc Health Inc. and Livongo Health Inc. have inked a definitive merger agreement with a value of $18.5 billion. The transaction is expected to close by the end of the fourth quarter, subject to shareholder approvals and other customary closing conditions.
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Regulatory actions for Aug. 5, 2020

Aug. 5, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endologix, Eyenuk, Life Spine, Neumodx, Roche, Sentinel Diagnostics, Siemens Healthineers.
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Eko product image

Eko teams up with Astrazeneca to advance heart failure diagnosis tools

Aug. 4, 2020
By Meg Bryant
Eko Devices Inc. said Tuesday that it is collaborating with British pharma giant Astrazeneca plc to speed the development of digital health tools to improve early detection of cardiovascular diseases, including heart failure. The partnership could lead to more personalized care for heart failure patients, improving long-term outcomes.
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U.S. White House

White House moves on telehealth executive order to counter rural hospital closure

Aug. 4, 2020
By Mark McCarty
The Trump administration has issued an executive order designed to improve access to telehealth for Medicare beneficiaries in rural America, making permanent numerous changes that had been temporarily added for the COVID-19 pandemic. The news arrives as the Centers for Medicare and Medicaid Services (CMS) posted the draft Medicare physician fee schedule (MPFS) complete with expanded use of telehealth for a number of services.
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Regulatory actions for Aug. 4, 2020

Aug. 4, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Biotricity, Siemens Healthineers.
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Artificial intelligence and digital health icons

Investor unruffled over FDA’s approach to AI in discussion paper

Aug. 3, 2020
By Mark McCarty
A number of entities have sounded off on the FDA’s discussion paper for artificial intelligence (AI), including several medical societies that would like to see autonomously operating algorithms subjected to more stringent review than supervised algorithms. Vibhor Rastogi, general partner at Symphony AI of Los Altos, Calif., told BioWorld that the company is on board with many of these concerns, adding that the FDA discussion paper does a “good job of balancing innovation and patient safety.”
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