Tag: medical devices

FDA announces class 1 recalls for premixed embolic, infusion pump software

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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By: Matt Danford
April 18, 2024
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FDA Class 1 recall renews concern about historically problematic heart pumps

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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By: Matt Danford
April 17, 2024
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FDA: Surgical mesh mini-slings comparable to mid-urethral slings for stress urinary incontinence

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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By: Matt Danford
April 15, 2024
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Newly FDA-approved microsurgical system holds promise for training, new treatments

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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By: Matt Danford
April 10, 2024
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Magnetic device controls nanorobots used in surgery

Editor's Note Scientists have found a new way to more precisely control tiny robots used in surgeries using an oscillating magnet. The findings were published in the journal npj Robotics (part of the Nature Portfolio) on March 28.  Nanorobots capable of transporting drugs, performing surgical procedures, or taking tissue measurements…

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By: Brita Belli
April 3, 2024
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FDA updates warning about plastic syringes made in China

Editor's Note An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality…

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By: Matt Danford
March 20, 2024
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Faster, safer brain drill used for first time in life-saving neurosurgery

Editor's Note A patient undergoing emergency neurosurgery at Northwestern Medicine became the first to benefit from a neurosurgical drill designed to eliminate the need for hand-crank operation. According to a March 5 report from Northwestern, the procedure occurred in October at Northwestern Memorial Hospital, “when Northwestern Medicine neurosurgeon Matthew Potts, MD used…

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By: Matt Danford
March 14, 2024
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New blood-pressure lowering device being used in clinical trial comprising four US healthcare institutions

Editor's Note The Smidt Heart Institute at Cedars-Sinai has introduced a pioneering device aimed at treating patients with difficult-to-manage hypertension, making it one of four institutions in the US and the first on the West Coast to make use of this technology, a March 8 press release published by Cedars…

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By: Tarsilla Moura
March 11, 2024
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Flexible sticker device detects postoperative gastrointestinal leaks

Editor's Note A medical device developed by researchers at Northwestern University and Washington University School of Medicine could enable clinicians to monitor the health of a patient’s organs following surgery. The findings appeared in the journal Science on March 7.  Patients who undergo gastrointestinal surgeries—including pancreatic surgery—can develop anastomotic leaks…

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By: Brita Belli
March 8, 2024
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Negative pressure wound therapy reduces SSI across surgical specialties

Editor's Note Compared with standard wound dressings, single-use negative pressure wound therapy (NPWT) devices can reduce the incidence of surgical site infection (SSI) in at-risk patients with closed surgical incisions across a range of surgical specialties, according to a data review highlighted in the February issue of the American Journal…

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By: Matt Danford
March 6, 2024
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