Brainomix Ltd. received U.S. FDA clearance for its Brainomix 360 E-aspects tool, a fully automated AI-imaging solution for stroke assessment. Powered by explainable AI, the Brainomix 360 E-aspects tool, which is already CE-marked, assesses non-contrast CT scans to automatically generate a score and measures the volume of ischemic signs. It also features an overlaid heatmap to visually assist clinicians when treating stroke patients.
At the European Congress of Radiology 2023 in Vienna, a session was devoted to photon-counting CT (PCCT). A team of five clinical researchers from Germany, Ireland, Norway, the Czech Republic and Slovakia spent an hour presenting an update on the latest clinical progress for this new medical imaging technology.
United Imaging Healthcare Co. Ltd. (UIH) presented its Umr Jupiter 5.0T scanner at the European Congress of Radiology in Vienna. This new ultra-high-field 5 Tesla MRI scanner supports exclusive whole-body clinical and research applications.
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
Avicenna.AI SAS secured a further $7.5 million in series A funding, bringing the total aggregated investment in the company so far to $10.4 million. The round was backed by the two existing Paris-based investors: Cemag Invest SAS and Innovacom Gestion SAS. “Thanks to this funding, we are now able to ramp deployment of our software platform around the world, as well as diversify our offering into new areas of medicine,” Cyril Di Grandi, CEO and co-founder of Avicenna.AI SAS, told BioWorld.
Shukun Technology Inc.’s recently approved AI-based system to assess coronary arteries can get results in minutes, significantly speeding up diagnostics.
Bayer AG acquired Blackford Analysis Ltd., a British developer of artificial intelligence systems that help make diagnoses using medical images in the U.K. and U.S. The companies did not disclose any financial details. “This deal is part of our strategy to drive innovation in radiology, including the development and adoption of AI within the workflow, with the goal of ultimately improving patient care and advance our position in digital medical imaging,” Stefan Oelrich, a board member at Bayer AG and president of Bayer’s pharmaceutical division, told BioWorld.
Cardiorenal Systems Inc. has scored a U.S. FDA breakthrough device designation for technology to prevent patients undergoing cardiac surgery from developing acute kidney injury (AKI). AKI is reported in up to 30% of approximately 780,000 cardiac surgeries performed each year in the U.S., Europe and the Middle East, complicating patient recovery, prolonging ICU hospitalization and contributing to patient mortality after surgery.
Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first patient in the world underwent treatment with a Halcyon system with Hypersight last week.
