Neve Ilan, Israel-based Nano-X Imaging Ltd., had rocked the world of medical imaging with promises of X-ray imaging systems that provide low-cost tomosynthesis, but the U.S. Securities and Exchange Commission says the company overpromised on the low-cost claim. The SEC said the actual production cost of the Nano-X ARC systems is at least double the $12,000 per-unit figure routinely touted by the company’s former CEO, Ran Poliakine, a factual misrepresentation that helped the company raise $165 million in an initial public offering.
A surgical navigation platform developed by Proprio Inc., that is intended to replace traditional surgical technologies which produce harmful radiation and can impede surgical workflow, won U.S. FDA 510 (k) clearance.
The U.S. FDA recently proposed a modest overhaul of the rules pertaining to radiological products and other categories of products in an effort to eliminate duplicative or obsolete rules, such as a requirement for triplicate reports for variances in system performance.
Diagnostic Medical Systems Group SA (DMD) is selling its entire stake in the share capital of Hybrigenics SAS, a biotech company listed on the Paris Euronext Stock Exchange since 2007. This sale of 116,911,328 shares, representing 43.41% of Gard, France-based Hybrigenics’ share capital, will allow DMS Group to refocus on its core imaging business. “We will strengthen our free cash in order to ramp the launch of new technology in medical imaging,” Samuel Sancerni, CEO of Diagnostic Medical Systems, told BioWorld.
Researchers at Massachusetts General Hospital (MGH) and the Massachusetts Institute of Technology (MIT) have developed a deep learning computer model that expands on the ability to identify discrete data contained in breast imaging to better predict a woman’s chances of developing breast cancer.
A research team from the Technical University of Munich (TUM) in Germany has for the first time managed to integrate the dark-field X-ray technique into a CT scanner suitable for clinical application. They have just published an article describing how they integrated this technology, in the journal Proceedings of the National Academy of Sciences.
Egg Medical Inc. secured a $13 million investment from TVM Capital Life Science to solve the Humpty-Dumpty problem that plagues interventional cardiology – the scattering of radiation during X-ray guided procedures. The company’s Eggnest XR product contains the radiation using a carbon fiber platform with integrated radiation shielding that replaces the patient mattress on the X-ray table.
Fujifilm Holdings Corp. has bagged the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)’s approval for CXR-AID, its artificial intelligence (AI) powered chest X-ray analysis system developed in collaboration with Lunit Inc.
PARIS – Gleamer SAS said Radiology published compelling results from a study evaluating the performance of its artificial intelligence (AI) system Boneview, which helps radiologists and emergency doctors detect and localize fractures. This is the first study to evaluate the performance of AI-assisted health care professionals in locating bone fractures on all appendicular X-rays.