Medical Devices


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    Philips Respironics to end manufacturing at two Pennsylvania plants: report

    Philips said it would transition operations from the two sites to a third-party manufacturer. The plan will cut 300 jobs, according to the Pittsburgh Post-Gazette.

    By June 21, 2024
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    Courtesy of Tandem Diabetes Care
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    Tandem names Jean-Claude Kyrillos as chief operating officer

    The appointment gives Kyrillos a leading role in work to expand the insulin delivery company’s global operations and achieve profitable growth.

    By June 21, 2024
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    J&J creates open digital platform for surgical applications

    J&J at first will focus on surgical video, telepresence and planning and limit access to select hospitals. It plans to make the platform more widely available in 2025.

    By June 21, 2024
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    Sasirin Pamai via Getty Images
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    Globus Medical gets FDA nod for ortho robot

    With the clearance, Globus could gain share in the roughly $15 billion market for reconstructive orthopedic surgery, RBC Capital Markets analyst Shagun Singh said. 

    By June 20, 2024
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    Retrieved from Dermtech on June 20, 2024
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    Dermtech files for Chapter 11, lays off 20% of staff

    The diagnostic test maker will continue to hunt for a buyer for its skin cancer detection patch.

    By June 20, 2024
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    David McNew via Getty Images
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    Former Stimwave CEO gets 6 years in prison for fake device scheme

    The case centered on allegations that Stimwave marketed a dummy piece of plastic as a receiver of radiofrequency energy.

    By June 20, 2024
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    Sarah Silbiger/Getty Images via Getty Images
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    FDA official sets out approach to AI in medical devices

    Developing quality assurance practices for AI models should be a priority, said Troy Tazbaz, director of the CDRH’s Digital Health Center of Excellence.

    By June 18, 2024
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    Courtesy of Boston Scientific
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    Boston Scientific buys Silk Road Medical for $1.26B

    Silk Road developed a minimally invasive procedure to prevent stroke in patients with carotid artery disease.

    By June 18, 2024
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    Courtesy of Medtronic
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    Medtronic’s president of global regions set to retire in June

    Medtronic made Rob ten Hoedt one of four regional leaders after it bought Covidien almost 10 years ago.

    By June 18, 2024
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    Permission granted by Boston Scientific
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    PFA devices are changing AFib treatment. The next wave could grow the market further.

    New pulsed field ablation systems from Boston Scientific and Medtronic are already reshaping the cardiac ablation market, but upcoming devices could spur even greater adoption.

    By June 17, 2024
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    Sarah Silbiger via Getty Images
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    FDA creates transparency principles for AI in medical devices

    The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.

    By June 17, 2024
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    Sarah Silbiger via Getty Images
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    Merit Medical recalls plastic syringes made by Jiangsu Shenli

    Merit’s recall comes amid broader FDA scrutiny of plastic syringes made in China.

    By June 17, 2024
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    Guillermo Spelucin Runciman via Getty Images
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    Medtech group updates EtO standard for first time in 25 years

    The Association for the Advancement of Medical Instrumentation said the changes incorporate new technologies and address industry challenges.

    By June 14, 2024
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    Agilent to cut 3% of employees as sluggish lab equipment market persists

    An Agilent spokesperson said the layoffs follow job cuts announced late last year amid a slower-than-expected market recovery.

    By June 14, 2024
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    Sarah Silbiger via Getty Images
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    Teleflex catheter kit recall linked to 31 injuries, 3 deaths

    Teleflex reported 322 complaints about a safety problem that can prevent the balloon from fully inflating.

    By June 14, 2024
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    Sara Silbiger via Getty Images
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    Medline pulls thousands of endotracheal tubes due to risk of airway blockage

    Medline asked hospitals to immediately identify and destroy any affected devices.

    By June 13, 2024
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    Masimo embroiled in dual DOJ, SEC probes

    Masimo will have to juggle the government inquiries while also dealing with an activist investor-led proxy battle.

    By June 13, 2024
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    Courtesy of Philips
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    Philips launches stent system to restore blood flow in blocked veins

    Philips acquired the device as part of its 227 million euro purchase of Vesper Medical in 2022.

    By June 13, 2024
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    Fotolia
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    Kardium raises $104M to develop pulsed field ablation system

    Kardium will use the funding to complete a clinical study for pursuing regulatory approvals and build its manufacturing, clinical support and commercial teams.

    By June 12, 2024
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    SDI Productions via Getty Images
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    Women underrepresented in trials of high-risk medical implants: study

    A median of 33% of study subjects were women, and the figure was significantly lower in cardiovascular trials.

    By June 12, 2024
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    PeopleImages via Getty Images
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    Zimmer partners with Think Surgical to launch knee surgery robot

    J.P. Morgan analysts said the move is a “low cost way of adding more robotic options” for Zimmer, but they were still unsure about the added value of the partnership.

    By June 12, 2024
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    Sarah Silbiger via Getty Images
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    Abbott issues recall for Heartmate system monitor

    Abbott’s heart pump system and related products have been part of multiple Class I recalls this year.

    By June 11, 2024
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    Vyaire Medical files for Chapter 11 bankruptcy

    CEO John Bibb said the move gives Vyaire “breathing room” as the ventilator manufacturer looks to sell its businesses.

    By June 11, 2024
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    Stringer via Getty Images
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    GE Healthcare names new leaders of imaging and ultrasound units

    Roland Rott will become CEO of GE Healthcare’s imaging business, while Philip Rackliffe will lead a combined ultrasound and image guided therapies segment.

    By June 11, 2024
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    Permission granted by Abbott
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    Abbott ramps up over-the-counter CGM race with new sensors

    Abbott will launch two over-the-counter glucose monitors in the U.S., competing directly with Dexcom’s Stelo.

    By June 10, 2024