Editor's Note Minimally invasive surgery (MIS) with the Artemis Neuro Evacuation Device reduced hematoma volume efficiently and lowered serious adverse events but did not improve long-term disability or mortality compared with medical management in spontaneous supratentorial intracerebral hemorrhage (ICH), JAMA Neurology September 2 reports. The “MIND randomized clinical trial” enrolled…
Editor's Note A simple adjustment to walking style can relieve osteoarthritis pain as well as medication and may delay the need for knee surgery, according to a year-long clinical trial published in The Lancet Rheumatology and covered by The Independent on August 18. As detailed in the article, University of…
Editor's Note Dozens of companies are racing to stake a claim in the rapidly expanding surgical robotics market, with multiple launches, partnerships, and regulatory milestones signaling a pivotal moment for the field. Challengers to established leaders are advancing soft tissue systems, targeting specialty niches, and building executive teams to scale…
Editor's Note The Food and Drug Administration (FDA) has issued a series of early alerts this month regarding high-risk recalls from several leading medical device makers, citing patient safety risks ranging from pump failures to vascular complications. These alerts highlight issues with products from Johnson & Johnson’s (J&J’s) Abiomed unit,…
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement, the recall…
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…
Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus). According to the agency’s July 22…