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.

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.

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.

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.

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.

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.”

HONG KONG – Singapore is Biofourmis Inc.’s latest destination for its Biovitals Sentinel platform to remotely monitor COVID-19 patients, with the country’s Ministry of Health (MOH) becoming the company’s latest customer.