Medical Devices: Page 2
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solarseven via Getty Images
FDA-ordered report tackles how to manage cybersecurity risks of legacy devices
The report from MITRE proposes multiple actions for protecting older medical devices, including research into more modular devices and collecting data on cyber risks.
By Nick Paul Taylor • Nov. 16, 2023 -
Permission granted by Vicarious Surgical
Vicarious delays surgical robot as integration challenges, R&D cuts slow development
Analysts at BTIG warned the company is “walking a very tight rope” and downgraded the stock.
By Nick Paul Taylor • Updated Nov. 15, 2023 -
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Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom
TrendlineThe MedTech Dive Outlook on 2021
The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.
By MedTech Dive staff -
Retrieved from Food and Drug Administration.
Cardinal’s changes to disposable syringes trigger FDA Class I recall notice
The problem is linked to 15 reports of delayed therapy and 13 reports of inaccurate dispensing.
By Nick Paul Taylor • Nov. 15, 2023 -
Retrieved from Medtronic on October 05, 2023
Stolen Medtronic laryngoscopes deemed Class 1 recall
Some of the defective devices turned up on Facebook Marketplace before the posting was taken down, the FDA said in the recall notice.
By Susan Kelly • Nov. 15, 2023 -
Courtesy of Abbott
Abbott study links aspirin-free regimen to better outcomes in heart pump patients
An accompanying editorial said the “data provide an opportunity to immediately improve the outcomes of patients implanted with contemporary LVADs.”
By Nick Paul Taylor • Nov. 15, 2023 -
Permission granted by Boston Scientific
Large registry study upholds safety findings for Boston Scientific’s Farapulse device
The results, presented at the American Heart Association Scientific Sessions, showed a low rate of adverse events for the pulsed-field ablation treatment.
By Elise Reuter • Nov. 14, 2023 -
Win McNamee/Getty Images via Getty Images
Biden initiative aims to accelerate women’s health research
AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.
By Susan Kelly • Nov. 14, 2023 -
Sara Silbiger via Getty Images
Olympus receives Class I recall label for another bronchoscope safety issue
The company's latest corrective action follows four reports of “endobronchial combustion” during procedures with its bronchoscopes.
By Ricky Zipp • Nov. 14, 2023 -
Douglas Cliff via Getty Images
Wegovy study details revive debate over GLP-1 impact on devices
The data confirmed a cardiovascular benefit for heart patients and showed the drug could help pre-diabetic patients control their blood sugar.
By Susan Kelly • Nov. 13, 2023 -
Bruce Bennett via Getty Images
Henry Schein says customer data breached in cyber incident
The company lowered its 2023 sales and earnings forecasts in response to the incident, which took some of its distribution systems offline.
By Elise Reuter • Nov. 13, 2023 -
Sponsored by ISACA
A catalyst for quality: FDA’s Voluntary Improvement Program saves time, improves process and enhances patient outcomes
Using ISACA's CMMI framework, medical device manufacturers have seen significant improvements, underscoring the program's positive influence on patient outcomes.
Nov. 13, 2023 -
Courtesy of ResMed
Resmed overhauls C-suite, creating 3 posts and parting ways with 2 execs
The company recently laid off 5% of its staff and stopped certain projects to lower operating costs.
By Nick Paul Taylor • Nov. 13, 2023 -
Sarah Silbiger via Getty Images
FDA warns providers about using surgical mesh for breast surgery after BD label update
The regulator reminded providers that there are “no surgical mesh products cleared or approved by the FDA for use in breast surgery.”
By Nick Paul Taylor • Nov. 13, 2023 -
Courtesy of Grail
Illumina explores options for Grail, hires advisers
The company, facing pressure from regulators to divest Grail, also formed a special committee to speed decisions on the fate of the liquid biopsy test maker.
By Susan Kelly • Nov. 10, 2023 -
Mario Tama/Getty via Getty Images
J&J orthopedics subsidiary undergoes layoffs at Colorado facility
DePuy Spine will cease manufacturing at the site as the medtech giant restructures its strategy in the sector.
By Joelle Anselmo • Nov. 10, 2023 -
mathisworks via Getty Images
Acutus laying off 65% of employees to focus solely on Medtronic heart device deal
The company has decided to exit the mapping and ablation business and focus its remaining cash on the Medtronic partnership.
By Nick Paul Taylor • Nov. 10, 2023 -
Permission granted by Stryker
4 takeaways from Stryker’s investor day
The company’s expected return to pre-pandemic operating margins, procedure backlogs and weight loss drugs were among the topics discussed at Wednesday’s event.
By Elise Reuter • Nov. 9, 2023 -
Permission granted by Becton Dickinson
BD’s 2024 forecast comes in ‘well below’ Wall Street’s expectations
Wall Street analysts called out BD’s disappointing 2024 EPS forecast in notes to investors, following a Thursday morning earnings call.
By Ricky Zipp • Nov. 9, 2023 -
Courtesy of Dexcom
NICE backs use of hybrid closed loop systems for Type 1 diabetes, if companies offer discounts
The group’s recommendation gives around 150,000 people with Type 1 diabetes living in England the chance to access the systems, according to an NHS England official.
By Nick Paul Taylor • Nov. 9, 2023 -
Mario Tama via Getty Images
J&J’s Ottava robot arriving too late to threaten Intuitive: analysts
With J&J years from approval and hospitals committed to the da Vinci system, analysts see little threat to Intuitive for the foreseeable future.
By Nick Paul Taylor • Nov. 9, 2023 -
Courtesy of Masimo
Masimo lowers outlook, citing constrained hospital budgets
The patient monitoring company is also facing a slowdown in demand for the consumer audio products it acquired in a deal last year.
By Susan Kelly • Nov. 8, 2023 -
Courtesy of Recor
Recor wins FDA approval for renal denervation system
The approval makes Recor the first company to bring the treatment to the U.S. after getting an FDA panel nod in August.
By Elise Reuter • Nov. 8, 2023 -
Retrieved from Siemsens Website on July 01, 2022
Siemens Healthineers’ Varian rebounds; execs mum on diagnostics sale rumors
The company's diagnostics unit continued to struggle amid layoffs and reports of a potential sale.
By Nick Paul Taylor • Nov. 8, 2023 -
Courtesy of Intuitive
Intuitive will weather weight-loss drug pressures, could see sales boost in ‘24: William Blair
Obesity drugs are constraining Intuitive's growth today, but the robotic surgery specialist could receive a sales boost in 2024 as patients reschedule bariatric procedures.
By Nick Paul Taylor • Nov. 8, 2023 -
Mario Tama/Getty via Getty Images
J&J targets 2024 for Ottava FDA filing
The company expects to file a submission for an investigational device exemption in the second half of 2024 that will allow it to begin clinical trials for the robotic surgery system.
By Susan Kelly • Nov. 7, 2023
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