Medical Devices: Page 74
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Illumina shares jump 17% after Icahn launches proxy fight
The activist investor said his board nominees would work to prevent Illumina from “sinking further into the quicksand” in a battle with regulators over the Grail acquisition.
By Susan Kelly • Updated March 14, 2023 -
Courtesy of Philips
Philips poaches new connected care business leader from Pear
Julia Strandberg, formerly Pear’s chief commercial officer, must revive a division still struggling with the recall of 5.5 million respirators.
By Elise Reuter • March 13, 2023 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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Silicon Valley Bank’s swift collapse appears to have left established medtech firms untouched
A review of companies covered by analysts reveals no significant direct exposure to SVB’s failure, but startups dependent on venture capital cash may be affected.
By Peter Green • March 13, 2023 -
Courtesy of Baxter
Baxter issues urgent correction for ventilation system due to risk of oxygen desaturation
Patients can continue to use the devices if they are checked daily and properly maintained, the company said in an announcement posted by FDA.
By Susan Kelly • March 13, 2023 -
Courtesy of Insulet Corp.
Insulet to join S&P 500 after Silicon Valley Bank ousted
Shares of the insulin pump maker rose Monday on news that it would join the stock index.
By Elise Reuter • March 13, 2023 -
Alex Wong via Getty Images
Medtech groups lose challenge to digital piracy rule in device repair case
Repair companies will still be able to access and use operating code to fix medical devices, after the court rejected arguments by AdvaMed and the Medical Imaging & Technology Alliance.
By Susan Kelly • March 13, 2023 -
Gorodenkoff/Shutterstock.com
Sponsored by EsperDevice management for mission-critical care: Maximizing efficiency and effectiveness
Reduce the complexity of device fleet management to deliver seamless mission-critical care.
March 13, 2023 -
Courtesy of LivaNova
LivaNova receives FDA nod for heart-lung machine
After beginning its European rollout last month, the UK-based device maker hopes to bring its market-leading position to the U.S.
By Peter Green • March 10, 2023 -
Permission granted by Erik Vollebregt
Q&AFriday Q&A: A regulatory attorney breaks down the EU MDR transition
Amsterdam-based regulatory expert Erik Vollebregt explains the agreement this week to extend the deadlines to comply with the EU’s Medical Device Regulation, and the issues that still need to be addressed.
By Susan Kelly • March 10, 2023 -
Ex-medtech CEO arrested over alleged scheme to sell dummy devices, defraud Medicare
Prosecutors accuse the former Stimwave CEO of engaging in a multi-year scheme to sell a device with no medical purpose for implantation into chronic pain patients.
By Nick Paul Taylor • March 10, 2023 -
Retrieved from Titan on September 12, 2022
Titan delisted from Nasdaq, as surgical robot maker struggles to sell assets
Titan's robotic surgery device faced delays in development that forced the firm to put off a planned FDA submission. The company has laid off its technical staff as it seeks to sell its assets.
By Elise Reuter • March 9, 2023 -
Courtesy of Auris/J&J
J&J lays off 350 people at robotics units, says ‘we have to get better’ with Ottava
CFO Joe Wolk said there is “a sense of urgency” at the company as it works to come from behind in the robotic surgery market.
By Nick Paul Taylor • Updated March 10, 2023 -
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More woes for breast implants, as FDA links procedure to squamous cell carcinoma
Three deaths were related to the cancer cases, the agency said.
By Elise Reuter • March 8, 2023 -
Permission granted by iRhythm Technologies
iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals
An analysis of Medicare claims data found iRhythm Technologies’ Zio XT outperforms other ambulatory cardiac monitors.
By Nick Paul Taylor • March 8, 2023 -
Courtesy of Sooma
Sooma’s neuromodulation therapy for depression granted FDA breakthrough status
The patient-administered device, which uses a mild electrical current to improve depressive symptoms, showed promising results in a clinical trial.
By Nick Paul Taylor • March 8, 2023 -
Courtesy of Medtronic
Medtronic’s pulsed field ablation device meets safety, efficacy metrics in trial
Medtronic’s device didn’t outperform competing systems being developed by J&J and Boston Scientific, but the results should be enough to secure FDA approval, one analyst wrote.
By Elise Reuter • March 7, 2023 -
AdvaMed calls Europe’s MDR extension a ‘strong step forward,’ but warns challenges remain
The extra time to certify medical devices in Europe is intended to prevent shortages, but the regulatory overhaul still poses problems for medtech firms, the U.S. lobbying group says.
By Susan Kelly • March 7, 2023 -
Permission granted by Medtronic
Medtronic TAVR data in healthier patients fuels battle with Edwards for heart valve market share
The results show that low-risk aortic stenosis patients have better outcomes after three years when catheters are used to insert their replacement heart valves, rather than traditional open-heart surgery.
By Nick Paul Taylor • March 7, 2023 -
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Medtechs plan to centralize regulatory information management in modernization push: survey
The survey suggests that more than two-thirds of medtech firms need to update and automate their regulatory record-keeping and submission practices.
By Nick Paul Taylor • March 7, 2023 -
Permission granted by Abbott Laboratories
Abbott CGMs cleared to integrate with automated insulin delivery systems
The regulatory decision allows the devices to be used in artificial pancreas systems, and positions Abbott as a competitor to Dexcom in the space.
By Elise Reuter • March 6, 2023 -
Courtesy of Abbott
Abbott’s TriClip improves tricuspid regurgitation in pivotal trial ahead of showdown with Edwards
The transcatheter repair clip beat the established medical therapy on the primary composite endpoint, setting up a battle with rival Edwards for a $5 billion market.
By Nick Paul Taylor • March 6, 2023 -
Win McNamee / staff via Getty Images
Elon Musk’s bid to study brain implant in humans rejected by FDA on safety grounds: report
The FDA reportedly raised concerns about the device’s lithium battery, the potential for its wires to migrate across the brain, and how it would be removed.
By Nick Paul Taylor • March 3, 2023 -
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FDA Class I recalls hit 15-year high in 2022
The jump in activity happened in a year in which the number of all recalls rose by around 10%, including actions by Baxter, Medtronic and Philips.
By Nick Paul Taylor • March 3, 2023 -
Permission granted by Medtronic
Medtronic says renal denervation consensus could open up multibillion-dollar market
European recommendation will help to start talks with insurers, says Medtronic executive.
By Elise Reuter • March 2, 2023 -
Megan Quinn/MedTech Dive
AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access
Congress should also prioritize protecting the medtech manufacturing supply chain and enact diagnostic testing reform, the lobbying group said in releasing a set of nine policy goals.
By Susan Kelly • March 1, 2023
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