Editor's Note The Food & Drug Administration (FDA) on January 2 identified the recall by LivaNova of its VNS Therapy SenTiva Generator System as Class I, the most serious. The recall was initiated because of an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy…
Editor's Note Johnson & Johnson’s Depuy Synthes and Israel-based Zebra Medical Vision have partnered to develop artificial intelligence (AI)-based algorithms for use in preoperative orthopedic surgical planning, the January 2 BioWorld reports. The algorithms would enable the creation of 3D models from x-ray images so that radiation risks and costs…
Editor's Note In this first-year analysis of a data capture system called the OR Black Box, frequent intraoperative errors, events, variation in surgeons’ technical skills, and a high amount of environmental distractions were identified. In 132 patients having elective laparoscopic general surgery: auditory distractions occurred a median of 138 times…
Editor's Note The Food & Drug Administration (FDA) on December 30 announced a public workshop on the “Evolving Role of Artificial Intelligence [AI] in Radiological Imaging, which will take place February 25-26, 2020, at the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland. The workshop will include discussions on…
Editor's Note The US House of Representatives on December 17 passed a year-end spending bill that repeals several Affordable Care Act (ACA) taxes, including the 40% tax on generous health insurance plans and the 2.3% tax on the sale of medical devices, the December 17 Reuters reports. The bill also…
Editor's Note The Food and Drug Administration (FDA) on December 17 identified the recall by Cook Medical of its CrossCath Support Catheters as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause the radiopaque marker bands on the catheters to dislodge or…
Editor's Note Boston Scientific announced December 13 that it had received Food & Drug Administration (FDA) 510(k) clearance for the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D, which was granted Breakthrough Device Designation from the FDA, eliminates the need for…
Editor's Note Integrating artificial intelligence (AI) with surgical decision making could transform care by augmenting the decision to perform surgery, informed consent process, identification and mitigation of modifiable risk factors, decisions on postoperative management, and shared decision for resource use, this review finds. Surgical decision making involves hypothetical-deductive reasoning, individual…
Editor's Note Researchers at UT Southwestern Medical Center in Dallas have developed a new software tool that uses artificial intelligence (AI) to recognize cancer cells from digital pathology images, a December 9 UT Southwestern news release reports. The spatial distribution of different types of cells can reveal a cancer’s growth…
Editor's Note The Center for Fluorescence-Guided Surgery at UC San Diego Health is the first in the country dedicated to delivering a new caliber of surgical accuracy that allows surgeons to identify cancerous or critical tissues with GPS-like precision by lighting them up, the December 5 UC San Diego Health…