Medical Devices: Page 63
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Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight
Warning that caution is not being exercised with use of artificial intelligence in healthcare, the World Health Organization called for rigorous oversight of the new technology.
By Susan Kelly • May 17, 2023 -
Courtesy of Masimo
ITC to review ruling that Apple violated Masimo’s patents
If the ITC finds Apple improperly used Masimo’s pulse oximetry technology in the Apple Watch, the commission could ban imports of some Watch versions.
By Elise Reuter • May 17, 2023 -
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 -
Courtesy of Abbott Laboratories
Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market
The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device.
By Nick Paul Taylor • Updated May 17, 2023 -
Courtesy of Philips
Philips claims exposure to foam particles in recalled sleep apnea devices unlikely to harm patients
Inhaling foam particles or chemicals from the recalled devices is unlikely to significantly harm patients, Philips argued, but it added that regulators may reach a different conclusion.
By Elise Reuter • Updated May 16, 2023 -
Permission granted by Intuitive Surgical
Intuitive Surgical promotes Dave Rosa to president, Guthart remains CEO
The surgical robot maker said longtime CEO Gary Guthart retains his role and will continue to lead the company.
By Susan Kelly • May 16, 2023 -
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Cook Medical lays off 500 after ‘significant change’ to operating environment
In a memo to employees, CEO Pete Yonkman said that hourly manufacturing and distribution workers won’t be laid off because demand for Cook Medical’s products “continues to grow.”
By Nick Paul Taylor • May 16, 2023 -
Courtesy of Verily
Diabetes app developers must generate more data on clinical effectiveness, study says
The researchers saw a need for more data on the wider clinical effectiveness of apps in the management of Type 1 diabetes and prediabetes.
By Nick Paul Taylor • May 16, 2023 -
Permission granted by Embecta
Embecta joins Tidepool to develop insulin pump, raises Q2 growth outlook
Embecta advanced its pump project by partnering with Tidepool, a nonprofit that has developed diabetes management software that can work across different brands of pumps and monitors.
By Nick Paul Taylor • May 15, 2023 -
Courtesy of GE HealthCare
GE HealthCare’s order book raises questions about sales-growth potential, analysts say
BTIG analysts found “lower order growth than what is assumed” and shared concern the medtech company may face challenges just four months after it was spun off from parent General Electric.
By Nick Paul Taylor • May 12, 2023 -
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AdvaMed cites EPA’s own impact assessment to push back against ethylene oxide proposals
Medtech firms and environmental regulators are at loggerheads as the industry looks for a safe and cost-effective alternative to ethylene oxide for sterilizing reusable devices.
By Nick Paul Taylor • May 12, 2023 -
Neilson Barnard via Getty Images
Icahn wins proxy firm nod to oust CEO from Illumina board
The recommendation from Glass Lewis is a boost for Icahn’s plan to force change at the DNA sequencer, as he and Illumina’s management battle for proxies ahead of a shareholder vote on May 25.
By Elise Reuter • May 11, 2023 -
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Google adds image analysis capabilities to generative AI model, enabling dialogues with doctors
The Med-PaLM 2 has the ability to review X-rays and mammograms, write reports about images and respond to follow-up questions from caregivers.
By Nick Paul Taylor • May 11, 2023 -
Courtesy of Nuvasive
NuVasive grows sales in Q1, allaying concerns about impact of $3.1B Globus merger
The growth reflects “increased procedure volumes” and a “continued surge in demand” for NuVasive devices.
By Nick Paul Taylor • May 11, 2023 -
Courtesy of GuardantHealth
Guardant blood test detects 83% of colorectal cancer cases, but fewer in early stage
Analysts said the test is likely to meet the bar for FDA approval, but its flaws in detecting early-stage cancer weaken its chances against Exact Sciences’ stool-based test, Cologuard.
By Elise Reuter • May 10, 2023 -
Patrik Stollarz / Staff via Getty Images
Philips loses vote as shareholders push back against handling of respirator recall
The vote will allow investors to sue board members over their actions in 2022. Philips blamed the ballot loss on guidance from proxy advisors.
By Nick Paul Taylor • May 10, 2023 -
Courtesy of Hologic
New breast cancer screening guidelines could boost mammography sales
Hologic, which makes mammography machines, could see an increase in its installed base, according to Needham analysts.
By Elise Reuter • May 9, 2023 -
Retrieved from Baxter on May 09, 2023
GE HealthCare poaches Baxter’s CFO
Jay Saccaro leaves Baxter after eight years as CFO; Helmut Zodl remains at GEHC to run special projects.
By Elise Reuter • May 9, 2023 -
Courtesy of GE HealthCare
Baxter, GE HealthCare, Philips are at risk from changes in hospital spending: Moody’s
Volatility in equipment orders from hospital customers will probably continue for at least the next 12 to 18 months, the analysts said.
By Nick Paul Taylor • May 9, 2023 -
Kevin Dietsch via Getty Images
FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech
The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.
By Nick Paul Taylor • May 9, 2023 -
Permission granted by Boston Scientific
Q&AFriday Q&A: Boston Scientific’s De Rosa on the rise of an AFib ‘game changer’
The Switzerland-based vice president of rhythm management for Europe, the Middle East and Africa expects a “massive shift” to pulsed field ablation from other atrial fibrillation treatments.
By Susan Kelly • May 5, 2023 -
Mark Wilson via Getty Images
Boston Scientific gets DOJ subpoena for documents related to heart monitoring
The disclosure comes as cardiac monitoring device maker iRhythm also said it received a request from the Justice Department.
By Susan Kelly • May 5, 2023 -
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ZimVie will lay off 5% of staff in bid to reduce costs, streamline business
The restructuring, along with reductions in discretionary spending, are expected to save the company $17 million to $20 million by 2024.
By Elise Reuter • May 5, 2023 -
Permission granted by iRhythm Technologies
iRhythm says it received DOJ subpoena regarding company’s ‘products and services’
The company’s shares fell more than 5% after the federal government requested documents.
By Nick Paul Taylor • May 5, 2023 -
Permission granted by Becton Dickinson
BD raises full-year forecasts again, expects Alaris infusion pump approval
The company said revenue increases in a number of its product lines were faster than market growth rates, suggesting it’s gaining share.
By Susan Kelly • May 4, 2023 -
Permission granted by Akili Interactive
Akili shares rise after early data shows video game treatment can improve attention in adults
The company aims to expand its video game-based treatment for ADHD to adults and adolescents.
By Elise Reuter • May 4, 2023
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