Medical Devices: Page 81
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Jury decides against Sterigenics in ethylene oxide trial, awarding $363M to the sole plaintiff
Sterigenics has more than 760 lawsuits pending against it in the local court for toxic emissions previously emitted by the plant.
By Nick Paul Taylor • Sept. 20, 2022 -
Jose Jimenez via Getty Images
Hurricane Fiona unlikely to significantly disrupt medical device supply: analysts
Medtech management teams expect fewer problems than after Hurricane Maria in 2017, noting that Hurricane Fiona is less severe and companies are better prepared.
By Nick Paul Taylor • Sept. 20, 2022 -
Explore the Trendline➔
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 -
Permission granted by Abbott Laboratories
Abbott’s latest Amulet-Watchman data show more mixed results for the heart devices
The latest head-to-head trial adds to the growing rivalry between Abbott and Boston Scientific in the left atrial appendage closure space.
By Ricky Zipp • Sept. 19, 2022 -
Courtesy of https://news.medtronic.com/newsroom-medtronic-hits-the-road-mobile-labs
FDA updates advice about Medtronic endotracheal tubes after Class I recall, patient death reports
The FDA provided more detailed recommendations on preventing and responding to airway obstruction that may occur when using some Medtronic endotracheal tubes.
By Peter Green • Sept. 19, 2022 -
Medtronic starts full US commercial release of updated Evolut TAVR system
Medtronic expects the device’s new features to increase its share of the multibillion-dollar heart valve replacement market.
By Nick Paul Taylor • Sept. 19, 2022 -
Courtesy of Edwards Lifesciences
Edwards gets FDA nod for mitral regurgitation treatment
The approval would bring a U.S. competitor to rival Abbott’s MitraClip device.
By Elise Reuter • Sept. 16, 2022 -
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Racial bias in pulse oximeters to be subject of FDA panel
The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.
By Peter Green • Sept. 16, 2022 -
Permission granted by Edwards Lifesciences
Q&AEdwards head of TAVR, Larry Wood, says more urgency needed in treating heart valve disease
Continued staffing shortages at hospitals are delaying the non-invasive aortic valve procedures for patients in need.
By Elise Reuter • Sept. 16, 2022 -
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Baxter’s recall of solution sets used in chemotherapy labeled Class I by FDA amid complaints of leaks
The regulator says the leaks could kill, but with 83 complaints it has not received reports of patient injuries or deaths.
By Ricky Zipp • Sept. 15, 2022 -
Retrieved from https://www.tassoinc.com/product-use-videos on September 15, 2022
Tasso’s at-home blood collection lancet wins FDA clearance
Tasso is pitching the device as an enabler of decentralized clinical trials because it could simplify the collection of blood at home.
By Nick Paul Taylor • Sept. 15, 2022 -
Mark Wilson/Getty Images via Getty Images
FBI warns of cyber risks from legacy medical devices
Outdated device software can put data, patient safety and hospitals’ operations at risk, the top U.S. law enforcement agency warned.
By Ricky Zipp • Sept. 15, 2022 -
Spencer Platt via Getty Images
Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts
Hospital staffing and supply chain issues are expected to improve, according to comments from Boston Scientific, J&J, Medtronic, and others.
By Nick Paul Taylor • Sept. 15, 2022 -
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Medtronic reports two deaths related to endotracheal tube recall
The company also received reports of three injuries related to airway obstruction with the tubes, adding to the company’s recent recall woes.
By Elise Reuter • Updated Sept. 14, 2022 -
Courtesy of https://www.edwards.com/devices/heart-valves/transcatheter-SAPIEN-3-Ultra
Edwards updates Sapien TAVR device for greater durability
The device uses Edwards’ Resilia tissue technology to enable dry storage and potentially extend device durability.
By Nick Paul Taylor • Sept. 14, 2022 -
Sony partners with hearing aid specialist to enter new over-the-counter market
Sony has identified the U.S. regulatory change as a chance to use its brand and audio technology to add a new growth driver to its portfolio.
By Nick Paul Taylor • Sept. 14, 2022 -
Investor lawsuit accuses Medtronic of failing to disclose insulin pump problems
The plaintiffs claim Medtronic failed to disclose that its product quality control systems were inadequate and that it was noncompliant with regulations.
By Nick Paul Taylor • Sept. 13, 2022 -
Mario Tama via Getty Images
J&J agrees to settle class action pelvic mesh suits in Australia for more than $200M
Shine Lawyers, the firm representing the patients, said that the Federal Court of Australia still needs to approve the terms of the agreement.
By Ricky Zipp • Sept. 13, 2022 -
Retrieved from Catheter Precision website on September 13, 2022
Catheter Precision agrees to reverse merger, securing cash to target cardiac electrophysiology market
By merging into Ra Medical Systems, Catheter Precision has access to public markets and a pool of cash needed to bring its product to market.
By Nick Paul Taylor • Sept. 13, 2022 -
Retrieved from Titan on September 12, 2022
Medtronic signs development deal with surgical robot-maker Titan Medical
Medtronic placed a $2.6 million order for some of the company’s instruments and cameras, and its interest in Titan should help the smaller firm as it seeks to win approval for its device and market it globally.
By Elise Reuter • Sept. 12, 2022 -
Patrik Stollarz / Staff via Getty Images
Philips says French prosecutors investigating respirator recall
While the company confirmed it faces lawsuits in France, Philips said it’s too early “to speculate about any potential exposure.”
By Elise Reuter • Sept. 9, 2022 -
Courtesy of https://mitraclip.com/
FDA alerts physicians to lock malfunction with Abbott’s MitraClip heart valve device
The problem, which the FDA said occurs in 1.3% of procedures, can have consequences including the need for surgery to treat significant residual disease.
By Nick Paul Taylor • Sept. 9, 2022 -
Sarah Silbiger via Getty Images
FDA: Reports of squamous cell carcinoma, lymphomas in scar tissue around breast implants
The report adds to the history of product safety problems for breast implant devices, including patient injuries and deaths.
By Ricky Zipp • Sept. 8, 2022 -
Website of medical device sales form: https://spwindustrial.com/baxter-sigma-spectrum-infusion-pump-s-w-ver-8-with-dual-antenna-wireless-batt/?gclid=Cj0KCQjwpeaYBhDXARIsAEzItbFttwA55ImqoesvcmNYfm6od_td4SGgOeNOqFOQohCiU_ci1yN-oHsaAqiFEALw_wcB
Cybersecurity firm finds vulnerabilities in Baxter’s Sigma infusion pumps
The weaknesses could allow attackers to access Wi-Fi data and make the device unavailable.
By Nick Paul Taylor • Updated Sept. 8, 2022 -
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French prosecutors investigating Philips Respironics recall: Reuters
In addition to a U.S. DOJ inquiry, Philips now faces an investigation from French prosecutors over its recall of sleep apnea machines and ventilators.
By Elise Reuter • Sept. 8, 2022 -
Courtesy of Abbott
Abbott heart device for newborns shows longer-term benefits with three-year data
The trial results give Abbott more evidence as it seeks to position the product as an alternative to medical management or surgical ligation.
By Nick Paul Taylor • Sept. 8, 2022
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