The Latest
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J&J files for FDA approval of Varipulse pulsed field ablation platform
The company wants to catch up with rival PFA systems from Medtronic and Boston Scientific that have already received FDA authorization.
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Abbott receives CE mark for 6-year insertable cardiac monitor
The device can continuously monitor a patient’s heart rhythms for either three or six years, depending on users’ needs.
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FDA re-issues ban on electric shock devices
The agency tried to ban the devices in 2020, but a federal appeals court overturned the decision.
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Masimo to split off consumer business
The decision comes two years after the pulse oximetry specialist acquired Sound United for its audio brands in a $1 billion deal.
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Court adviser sides with Illumina in EU row that triggered Grail fine
Illumina is still planning to divest Grail but may escape a fine of about 432 million euros imposed by the European Commission.
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Vyaire Medical recalls Airlife resuscitators over defect linked to 2 death reports
The recall covers respiratory support devices made in 2017 or earlier that can fail to provide enough ventilation.
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As FDA’s LDT rule looms, experts warn patients may lose access to critical tests
In testimony to Congress Thursday, industry and patient group leaders described the trade-offs expected from increased FDA oversight of laboratory-developed tests.
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Q&A
Stryker’s next head of joint replacement talks about new revision, robotics products
Katherine Truppi will become president of Stryker’s joint replacement business on March 31 after more than 20 years at the company.
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Medtronic claims win in Axonics patent row, pushes for jury trial
New rulings from a U.S. patent appeal board are the latest step in the companies’ intellectual property dispute over sacral neuromodulation devices.
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Abiomed’s latest Impella recall linked to 129 injury, 49 death reports
The J&J subsidiary warned about the risk of the catheter perforating the heart in updated instructions for use. Impella devices were part of four Class I recalls in 2023.
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Thermo Fisher, Bayer partner to develop companion diagnostics
The companies aim to identify potential patients for Bayer’s precision cancer therapies and increase access to the treatments.
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Insulet names Ana Maria Chadwick CFO
Chadwick succeeds Wayde McMillan, who left last year to become CFO for 3M’s health spinoff.
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Johnson Matthey to sell medical device components unit for $700M
The segment makes components for medical devices, such as nitinol and metallic coatings.
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Medtech layoffs continue in 2024
Medtronic, Baxter and QuidelOrtho are among the latest medical device companies that have announced plans to cut employees.
Updated March 21, 2024 -
Intuitive aims to keep challengers at bay with new surgical robot
The soft tissue robotics leader looks to set itself apart from upcoming rivals with the first new da Vinci system in 10 years.
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FDA sends 3 warning letters in probe of plastic syringes made in China
Agency officials are advising people to immediately transition away from using plastic syringes made by two Chinese companies.
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Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance
Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.
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Titan Medical to merge with imaging firm Conavi, ending strategic review
The combined company will focus on selling Conavi’s cardiovascular imaging system used in minimally invasive procedures.
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Siemens Healthineers to close fast track diagnostics unit, lay off about 90 workers
Demand for the products peaked during the COVID-19 pandemic but has fallen away since then.
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J&J Medtech, Nvidia partner to bring AI to the operating room
The companies see the collaboration as a way to help facilitate the fast, secure deployment of AI algorithms for surgical decision-making.
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Deep Dive
6 ways the FDA can improve medical device recalls
Experts said improving how adverse events are tracked and requiring manufacturers to use electronic notifications could make devices safer.
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Intuitive details launch plan for new da Vinci 5 robot
The fifth generation of the company’s flagship robotic surgery system will be introduced in a phased launch.
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Guardant posts data for colon cancer blood test amid push from rivals
The NEJM paper presents data from a study of more than 10,000 people Guardant ran to support authorization of its Shield DNA test.
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Intuitive lands FDA clearance for new da Vinci robot
The soft tissue robotics leader incorporated new features into the system, from tissue sensing feedback to a smaller size and more comfortable console.
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Q&A
Medtronic’s Sean Salmon on cardiovascular competition, carving out new markets
The president of Medtronic’s cardiovascular portfolio talked about renal denervation, a new procedure to reduce blood pressure and rising competition in cardiac ablation.