Editor's Note A January complaint about inefficient packaging for joint replacement products has prompted the manufacturer to recall certain knee and shoulder system devices after initially declining to take the products off the market, according to an April 23 report in Health Exec. The manufacturer, Exactech, is now recalling a…

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Editor's Note The second-ever living recipient of a gene-edited pig kidney was the first to have the new organ paired with a mechanical heart pump, according to an April 24 CNN report. The subject, 54-year-old Lisa Pisano, underwent the milestone surgery at NYU Langone Health. She had heart failure and…

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Editor's Note The US Food and Drug Administration has designated DeRoyal Industries’ recall of GeoMed custom tracecarts a class 1, the most serious type of recall indicating a risk of serious injury or death. According to the April 24 FDA notice, the recall is due to sterility concerns with the…

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Editor's Note The US Food and Drug Administration (FDA) approved Lumisight (pegulicianine), a fluorescent imaging drug used to detect cancerous tissue during lumpectomy, on April 17. Administered intravenously prior to surgery, Lumisight is designed for use with the Lumicell Direct Visualization System (DVS) or another imaging device that is FDA-approved…

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Editor's Note The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death. No injuries or deaths…

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The US Food & Drug Administration (FDA) announced a Class 1 recall on Monday for Abbott/Thoratec Corp.’s HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due due to biological material buildup obstructing the devices. According to an April 16 CBS News report, surgeons first noticed problems with the…

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Editor's Note Mini-slings for stress urinary incontinence (SUI) are similarly effective to mid-urethral slings over a 36-month timeframe, according to an April 11 announcement from the US Food & Drug Administration (FDA). FDA reached this conclusion after an in-depth, systematic literature review of post-market surveillance (“522”) studies required last year…

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Editor's Note The US Food & Drug Administration (FDA) has granted De Novo authorization for marketing MMI North America Inc.’s Symani Surgical System, according to the agency’s April 9 roundup. The system employs a motion scaling function to scale down surgeons movements for procedures requiring small instruments and/or microscopes, such…

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Editor's Note The US Food and Drug administration approved Zevtera for treating Staphylococcus aureus bacteremia (SAB) bloodstream infections, which are often acquired in healthcare settings. In the April 3 announcement, the agency notes the new antibiotic Zevtera (ceftobiprole medocaril sodium for injection) is effective for SAB-infected patients with right-sided infective…

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Editor's Note The US Food and Drug Administration (FDA) advises consumers to avoid topical analgesics marketed in violation of federal law by six different companies, including: TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9% SeeNext Venture,…

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