Noteworthy FDA approvals of the week: Ceiling-mounted CT angiography, AI for brain-adjacent bleeds
Two companies serving medical imagers just had products cleared for marketing in the U.S.
1. Viz.ai is cleared to sell Viz Subdural, which uses algorithms to automatically detect bleeding between the brain and the skull, aka subdural hemorrhage or subdural hematoma.
The usual cause of the condition is one or more blows to the head. Viz.ai says the offering, nicknamed Viz SDH, can distinguish between chronic and acute bleeds. Physicians equipped with this tipoff can triage acute patients to trauma care and chronic patients to appropriate care settings on a case-by-case basis.
The company says the algorithm hit 94% sensitivity and 92% specificity in a multicenter trial with more than 500 patient participants.
Viz.ai notes the SDH module follows FDA approvals granted a number of algorithms on the CMS-reimbursable Viz Platform. July 27 news release here.
2. Siemens Healthineers may market its Artis Icono Ceiling CT angiography system.
In a July 28 announcement, the company says the overhead-mounted C-arm has a speedy 3D spin time—2.5 seconds for the head, 4 seconds for side body sections—to minimize motion artifacts and reduce contrast dosing.
Rotational capabilities, simplified cabling and cone-beam data acquisition “enable precise intraoperative guidance and excellent clinical outcomes with minimal user interaction, faster system positioning, and reduced patient radiation dose,” Siemens says in a July 28 news release.
The company adds that Siemens tools such as embolization guidance and myNeedle Companion help streamline steps in complex procedures.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.