The U.S. FDA has granted 510(k) clearance to Siemens Healthineers AG for AI-Rad Companion Organs RT, the newest module in its platform of artificial intelligence-based software assistants. The radiation therapy planning aide joins earlier AI-Rad Companion modules for interpreting magnetic resonance imaging (MRI) studies of the brain and prostate, as well as one for chest computed tomography (CT) studies. Read More
With the world experiencing another wave of the coronavirus pandemic that threatens to overwhelm hospitals and testing capacity, the ability to quickly diagnose COVID-19 based on alternative methodologies has become increasingly important. For patients with respiratory symptoms, review of CT scans emerged as a relatively reliable indicator of infection with SARS-CoV-2 from the first days of its emergence, but the need for more accurate readings remains. Read More
The U.S. FDA’s device user fee schedule doubled for both the third and fourth user fee agreements over the prior iterations, but the pressure against another doubling for the fifth iteration of the user fee program is mounting. The Medical Imaging & Technology Alliance (MITA) said it sees a need to retain the user fee programs that are working and to jettison any underperforming programs, adding that user fees “should be stabilized around current funding levels.” Read More
LONDON – The Google artificial intelligence company Deepmind has developed an algorithm that can predict the 3D structure of a protein from its amino acid sequence, making it possible to solve the structures of proteins, such as G-protein coupled receptors (GPCRs), which are a mainstay of drug targeting but whose structure is challenging to determine with current methods. Read More
TORONTO – The Fionet Rapid Response Group formed by Toronto’s Fio Corp. and Relay Medical Corp. has received COVID-19 lateral flow rapid diagnostic tests (RDTs) from the European division of Abbott Laboratories Inc., Switzerland’s Roche Diagnostics AG and North York, Ontario’s Proprietary Innovation Labs Inc. for operation with its mobile testing and tracking platform. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FMCSA declines to allow ICD patients a commercial license; Pandemic not the time for trade restrictions. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3Shape, Align Technology, Aurora Spine, Carmat, LGC Group, Luminultra, Maplight Therapeutics, Qiagen, Salient Bio, Solos Endoscopy, Source Molecular. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerus, Ortho Clinical Diagnostics, Profound Medical. Read More
Keeping you up to date on recent developments in cardiology, including: Remote help to lower BP, control cholesterol; Improving screening for dual heart disease; Candidate shows promise in reducing heart failure. Read More
