Editor's Note The Food and Drug Administration on November 4 identified the recall by Abbott of its CentriMag Circulatory Support System as Class I, the most serious. The recall was initiated because of a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop,…
Editor's Note The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Surgical Risk Calculator accurately predicted four quality-of-life outcomes that transcend traditional measures of successful surgery and now reflects the expected effects of surgery on an older patient’s ability to function independently, finds this study presented October…
Editor's Note Heartvista (Los Altos, California) has obtained clearance from the Food and Drug Administration (FDA) for its artificial intelligence (AI)-assisted One Click autonomous MRI acquisition software for cardiac ischemia exams, the October 30 BioWorld MedTech reports. Integrated with existing MRI scanners, the software uses AI to guide image acquisition,…
Editor's Note In this study, machine learning algorithms accurately identified cancer patients who were at risk of 6-month mortality. Of 26,525 cancer patients analyzed, machine learning models based on structured electronic health record data accurately predicted short-term mortality risk with good discrimination and positive predictive value. When the gradient boosting…
Editor's Note An artificial intelligence (AI) model was able to detect breast cancer with nearly 90% accuracy when combined with analysis from radiologists, the October 18 Health IT Analytics reports. Researchers from New York University Schools of Medicine and Data Science developed the model to first consider small patches of…
Internal surgical staplers made headline news in 2019. Reports discussed the little-known US Food and Drug Administration database housing tens of thousands of stapler-related problem reports and covered the agency’s recent proposal to reclassify staplers as Class II devices, instead of the more lightly regulated Class I. ECRI Institute named…
Total knee arthroplasty (TKA) is a highly effective treatment for end-stage degenerative joint disease and has helped patients regain functional mobility with reduced pain and improved quality of life. Every year, almost 700,000 primary TKA procedures are performed in the US.1 This number is expected to grow to 3.48…
Editor's Note The University of California San Diego School of Medicine announced October 14 that it has expanded its Center for the Future of Surgery, one of few facilities in the world that teaches surgery in high-tech simulated ORs. This fall, the 22,000 sq-ft center added a new hybrid OR…
Editor's Note The Food & Drug Administration (FDA) on October 8 announced the recall by Medtronic of all models of its 6 French Sherpa NX Active Guide Catheters. Medtronic is recalling the catheters because of the risk of the outer material separating from the device, resulting in detached fragments that…
Editor's Note The ECRI Institute on October 7 released its annual safety report identifying the top 10 device hazards in hospitals, medical practices, and homecare for 2020. Topping the list was surgical stapler misuse and malfunction that can lead to patient harm. Third on the list is sterile processing errors…