Medical Devices: Page 83
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Review finds ‘paucity of robust evidence’ on impact of AI clinical outcomes
Of the nearly 12,000 articles on artificial intelligence, only 39 described randomized controlled trials, making it difficult to quantify the clinical benefits of using AI-assisted tools for patient care.
By Nick Paul Taylor • Aug. 26, 2022 -
Courtesy of Medtronic
Medtronic gets CE mark for drug-eluting stent and kicks off European launch
Medtronic calculated that changes to the stent resulted in a 16% improvement in drug deliverability.
By Nick Paul Taylor • Aug. 25, 2022 -
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 -
Retrieved from Integra Life on August 24, 2022
Integra pulls intracranial pressure monitors for inaccurate readings
After announcing an immediate voluntary removal of the devices, Integra trimmed its sales forecast for the quarter.
By Elise Reuter • Aug. 24, 2022 -
Retrieved from Abbott.com on August 24, 2022
Abbott wins FDA approval for spinal cord stimulation treatment of multi-site pain
The approval gives Abbott a new angle as it seeks to win market share from Boston Scientific, Medtronic and Nevro.
By Nick Paul Taylor • Aug. 24, 2022 -
Courtesy of https://news.getinge.com/hs-fs/hubfs/CUsersu4003864DesktopServo-u%204.0-1.jpg?width=1800&name=CUsersu4003864DesktopServo-u%204.0-1.jpg
Getinge’s recall of 11,000 ventilators labeled Class I event by FDA
The company is fixing a software bug that can inadvertently stop the ventilator from working.
By Nick Paul Taylor • Aug. 24, 2022 -
N/A via Getty Images
Philips respirator lawsuit builds as plaintiffs’ attorneys outline lengthy recall delays
New filings in a class action lawsuit allege that Philips waited years to disclose the risk of foam used in its sleep apnea machines and respirators, causing illness and injuries.
By Elise Reuter , Peter Green • Updated Aug. 23, 2022 -
Medtronic CEO says supply chain starting to stabilize as sales dropped, profits rose in Q1
The company is keeping its revenue forecast for fiscal year 2023 as it works to resolve issues with packaging and resins.
By Elise Reuter • Aug. 23, 2022 -
Courtesy of Insulet Corp.
Insulet’s Omnipod 5 insulin delivery system approved for preschool children
Adding preschoolers will broaden the market for the Omnipod after the launch of the device for people aged six years and older helped Insulet boost U.S. sales by 31% in the second quarter.
By Nick Paul Taylor • Aug. 23, 2022 -
Courtesy of Standard Bariatrics
Teleflex will buy Standard Bariatrics for $170M to gain Titan stapler
Standard’s investors could receive an additional $130 million if the unit reaches certain commercial milestones under Teleflex’s ownership.
By Elise Reuter • Aug. 22, 2022 -
Getty Images
Laser vision correction procedures fell 16% in the second quarter
The slowdown raises questions about whether demand is waning or if there was a pull-through in procedures last year.
By Elise Reuter • Aug. 22, 2022 -
Getty Images
Medical device industry poised to withstand an economic slowdown, experts say
While procedures volumes may decline, analysts said the effects likely won’t reach levels seen in 2020 or during the Great Recession.
By Ricky Zipp • Aug. 22, 2022 -
Courtesy of Edwards Lifesciences
Edwards gets CE mark for Pascal Precision system, allowing device to be marketed in Europe
The system, which is used to treat patients with mitral or tricuspid regurgitation, is also expected to get FDA approval by the end of the year.
By Elise Reuter • Aug. 19, 2022 -
Permission granted by ResMed
Q&AFriday Q&A: ResMed CEO Mick Farrell discusses Philips recall, improving supply chain, prioritizing patients
The executive spoke about managing a 12-month patient backlog following a spike in demand due to Philips’ recall and supply constraints.
By Ricky Zipp • Aug. 19, 2022 -
Medtronic gets third Class I label in 2022 for latest HVAD recall
The latest recall is for nearly 40,000 batteries for the HeartWare Ventricular Assist Device system.
By Ricky Zipp • Aug. 19, 2022 -
Permission granted by Eargo
Eargo plans to sell its hearing aids in stores after over-the-counter ruling
Best Buy, which announced it would sell over-the-counter hearing aids in more than 300 stores, has listed the Eargo 6 as one of the products it will offer.
By Elise Reuter • Aug. 18, 2022 -
Sarah Silbiger via Getty Images
Medical device recalls hit two-year high in Q2, report finds
While the number of recalls jumped in the period, the total units affected dropped to the lowest point in five years.
By Ricky Zipp • Aug. 18, 2022 -
Chris Jackson via Getty Images
New entrants may shake up hearing-aid market after FDA clears path for OTC sales
Startups, large tech companies and even traditional hearing-aid manufacturers are expected to offer over-the-counter devices.
By Elise Reuter • Aug. 17, 2022 -
Maddie Meyer via Getty Images
Moderna, after firing newly hired CFO, finds replacement in PerkinElmer executive
The COVID-19 vaccine maker has appointed James Mock, currently PerkinElmer’s CFO, as its next finance head, three months after ousting Jorge Gomez from the role.
By Ned Pagliarulo • Aug. 17, 2022 -
Permission granted by Philips
Philips’ next CEO, Roy Jakobs, provides ‘continuity’ amid ongoing recall: Barclays
Roy Jakobs currently leads the company’s connected care business and has helped oversee its recall response.
By Ricky Zipp • Aug. 17, 2022 -
Getty Images
Visibly wins FDA clearance for self-administered online vision test
The agency has placed restrictions on the test, limiting it to adults aged 22 to 40 years and cautioning that it only gives “supportive recommendations.”
By Nick Paul Taylor • Aug. 17, 2022 -
Patrik Stollarz / Staff via Getty Images
FDA reviews rise in Philips respiratory device reports, including 44 deaths
The agency received more than twice as many reports linked to foam breakdown from May to July than from April 2021 to April 2022.
By Nick Paul Taylor • Aug. 17, 2022 -
Courtesy of Outset Medical
Outset lands VA contract for portable hemodialysis system in ‘modest’ boost for sales
Stifel analysts said the contract could generate additional sales of as much as $50 million over five years.
By Nick Paul Taylor • Aug. 16, 2022 -
Getty Images
Hearing aids to be available over the counter following final FDA rule
Hearing aids were introduced for over-the-counter purchase in mid-October
By Elise Reuter • Aug. 16, 2022 -
Courtesy of Philips
Philips CEO Frans van Houten to step down in October amid recall woes; Jakobs named successor
The leadership change follows a July announcement that the company is in talks on a consent decree with the Department of Justice.
By Ricky Zipp • Aug. 16, 2022 -
Getty Images
Smartphone-linked blood pressure monitors fail to beat traditional devices, study finds
Individuals have been able to check their blood pressure at home using devices that lack connectivity features for years, raising the question of whether the technology improves outcomes.
By Nick Paul Taylor • Aug. 16, 2022
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