FDA authorizes marketing of first AI guided cardiac ultrasound
Editor's Note The Food & Drug Administration (FDA) on February 7 authorized marketing of software to assist in the acquisition of cardiac ultrasound images. The software, named “Caption Guidance,” uses artificial intelligence (AI) to help capture images of a patient’s heart from different angles, which are used to diagnose various…
FDA: Class I recall of GE Healthcare CARESCAPE Respiratory Modules, Airway Gas Option
Editor's Note The Food and Drug Administration (FDA) on February 4 identified the recall by GE Healthcare of its CARESCAPE Respiratory Modules and Airway Gas Option as Class I, the most serious. The recall was initiated because of a manufacturing issue that may cause the devices to display incorrect oxygen…
Cardinal Health recalls more than 9 million surgical gowns
Editor's Note Cardinal Health is voluntarily recalling 9.1 million potentially contaminated surgical gowns, 7.7 million of which were distributed to 2,807 facilities across the country, the January 22 Becker’s Hospital Review reports. The company took the action after learning of unsanitary environmental conditions at a plant in China that manufacturers…
FDA: Quality issues with Cardinal Health surgical gowns, packs
Editor's Note The Food & Drug Administration (FDA) on January 16 announced that Cardinal Health has alerted it customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain the gowns. Cardinal Health and the FDA recommend that customers immediately discontinue use…
FDA: Class I recall of Medfusion 4000 Syringe Pumps
Editor's Note The Food & Drug Administration (FDA) on December 19, 2019, identified the recall by Smiths Medical ASD, Inc of its Medfusion 4000 Syringe Pumps as Class I, the most serious. The recall was initiated because of malfunctioning low-battery alarms, which may lead to an interruption of therapy. The…
FDA: Class I recall of LivaNova VNS Therapy SenTiva Generator
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…
FDA workshop: Role of AI in radiological imaging
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…
FDA: Class I recall of Cook Medical’s CrossCath Support Catheters
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…
Boston Scientific receives FDA clearance for single-use duodenoscope
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…
FDA: Medtronic recalls SynchroMed II implantable drug infusion pump
Editor's Note The Food and Drug Administration (FDA) on December 16 announced that Medtronic has recalled its SynchroMed II implantable infusion pump. The pump is being recalled because of the potential presence of foreign particles inside the pump motor assembly that may lead to a pump motor stall. Medtronic has…
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