Clinical updates, including trial initiations, enrollment status and data readouts and publications: Baylis Medical, Biocardia, Biodesix, Bioskryb, Caredx, Hancock Jaffe Laboratories, Ihealthscreen, Multi Radiance Medical, Quotient, Sensus Healthcare.
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. is acquiring Scintec Diagnostics GmbH subsidiary Therapharm GmbH in a deal worth AU$33 million (US$24.24 million) plus royalties.
Zug, Switzerland-based Therapharm has developed a portfolio of radiolabeled diagnostic and therapeutic products, and the deal brings Telix a new targeting asset in hematology, Telix CEO Chris Behrenbruch told analysts during a Dec. 1 conference call.
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.
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.”
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.
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.
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.