The company's SSi Mantra 3 robotic surgery system has already gained regulatory approvals in several countries. FDA approval is anticipated by late 2025 or early 2026.
Vendor Centerline Biomedical recently initiated the action, removing certain IOPS (Intra-Operative Positioning System) Guidewires, used in vascular procedures, from the market.
Founded in 2019 and based in Chicago, the vendor offers a “leading” infrastructure platform for building, refining and deploying large-scale AI models in medical imaging.
Lines included in the kits were misassembled and could result in a botched blood transfusion. Due to the risk of serious injury or death, the recall has been designated as Class I.
Endotracheal tubes inside Medline neonatal intubation kits have been deemed too narrow, putting newborn patients at risk for hypoxia. This recall has been given the most serious FDA designation due to the risk of death.
Law firm Wright & Schulte said they filed a legal complaint on behalf of patients, pointing to the health system’s alleged lack of transparency and negligence in protecting data as the basis for the lawsuit.
Janet Wei, MD, examined the key differences between men and women when it comes to cardiovascular disease. These differences, she said, highlight why female patients need their very own treatment guidelines.