Rapidai Inc. Received U.S. FDA 510(k) clearance for Rapid RV/LV, the latest addition to its pulmonary embolism (PE) solution. Rapid RV/LV uses artificial intelligence to quickly calculate the right ventricle to left ventricle ratio based on an analysis of computerized tomography pulmonary angiograms. The ratio provides critical information for prioritization of PEs and integrates with Rapidai’s triage and notification and workflow products to manage patient care from suspected embolism to treatment. Read More
Alivecor Inc. has nudged the U.S. International Trade Commission (ITC) into issuing a limited exclusion order for products by Apple Inc. that are said to violate patents held by Alivecor, but there is one more stage gate to go for Alivecor. The ITC order notes that the exclusion won’t go into force until resolution of an inter partes review (IPR) involving the two firms, a process that could devour as much as a year and a half before a resolution is available. Read More
Creo Medical Group plc is on its way to being cash flow breakeven and profitable following a successful fundraise, which will accelerate the rollout of its suite of electrosurgical products, CEO Craig Gulliford told BioWorld. Read More
Esophageal cancer is often referred to as the “silent killer” because few people show any symptoms until after the cancer has spread. If localized, five-year survival rate is 46%, but that drops to just 5% when malignancy has reached distant parts of the body. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosig, Brain Biotech, Diagnamed, Dragon Scientific, Lucence, Mainz Biomed, Oncocyte Corp, Procyrion, Shape Memory, Transcode Therapeutics, Uni Targeting Research. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rapidai, Spectrum Solutions. Read More
