Medical Devices: Page 45
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Justin Sullivan via Getty Images
Apple Watch sales resume after latest twist in Masimo patent case
An appeals court has granted Apple’s emergency motion to pause the U.S. International Trade Commission’s ban on sales of its watches with a pulse oximetry feature.
By Susan Kelly • Jan. 3, 2024 -
Permission granted by Boston Scientific
Boston Scientific pulls forward expected approval for Farapulse PFA system
Analysts said a first quarter approval would increase their confidence in the company’s potential for sales growth of 10% or more.
By Nick Paul Taylor • Jan. 3, 2024 -
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 Roche
Roche to buy LumiraDx’s point-of-care technology for $295M
LumiraDx faces financial pressures amid declining test sales and a potential delisting from the Nasdaq.
By Elise Reuter • Jan. 2, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips recalls MRI machines due to risk of explosion
The Food and Drug Administration labeled the recall as a Class I event. There has been one report of a machine exploding in the 22 years the system has been in use.
By Nick Paul Taylor • Dec. 22, 2023 -
Permission granted by Agilent
Agilent to lay off about 400 workers amid site closures
Most of the reductions, which equal about 2% of the company’s global workforce, will be completed in the first quarter, Agilent said.
By Susan Kelly • Dec. 22, 2023 -
Resmed posts notice about risk of mask magnets interfering with medical implants
Like its rival Philips, Resmed has determined that patients should not wear magnetized masks near some implants.
By Nick Paul Taylor • Dec. 22, 2023 -
Drew Angerer via Getty Images
SEC charges former Stimwave CEO with $41M fraud scheme
The Securities and Exchange Commission alleges that Laura Tyler Perryman approved the creation of “fake” implantable parts for the company’s PNS device and defrauded investors of $41 million.
By Ricky Zipp • Dec. 21, 2023 -
Justin Sullivan via Getty Images
Apple to pause US sales of smartwatches with pulse oximetry
The tech giant’s move follows a USITC ruling that found the watches infringed some of Masimo's patents for measuring blood oxygen.
By Susan Kelly • Dec. 20, 2023 -
Sara Silbiger via Getty Images
FDA drafts guidance outlining real-world evidence for medical device submissions
By issuing the new guidance, the agency is meeting the requirements of a year-end spending bill.
By Elise Reuter • Dec. 19, 2023 -
Getty Images
Zimvie to sell spine business for $375M
Zimvie said the sale to H.I.G. Capital will leave the company focused on its dental business and help reduce debt.
By Elise Reuter • Dec. 18, 2023 -
Getty Images
BTIG analysts optimistic medtech will rebound in 2024 after ‘string of rough years’
Rising interest rates, fears about the impact of GLP-1 drugs and “choppy supply-chain dynamics” dragged on the industry this year, the analysts wrote.
By Nick Paul Taylor • Dec. 18, 2023 -
Permission granted by Glaukos Corporation
Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma
William Blair analysts said the product “should revolutionize how glaucoma is treated by addressing noncompliance with drops.”
By Nick Paul Taylor • Dec. 15, 2023 -
Courtesy of Tandem Diabetes Care
Tandem completes US launch of revamped diabetes management platform
The platform, Tandem Source, combines the features of the company’s legacy t:connect offerings with new data reports.
By Nick Paul Taylor • Dec. 15, 2023 -
Courtesy of Medtronic
Medtronic snags first pulsed field ablation approval in US
The treatment for atrial fibrillation has gained attention as a safer alternative to radiofrequency and cryoablation. Boston Scientific and Johnson & Johnson are also pursuing the PFA market.
By Susan Kelly • Dec. 14, 2023 -
Courtesy of ResMed
Resmed hails ‘significant victory’ as patent board rules in dispute with NYU
The decisions invalidate claims that NYU argued were infringed by Resmed’s sleep apnea devices.
By Nick Paul Taylor • Dec. 14, 2023 -
Alex Wong/Getty Images via Getty Images
In wake of Philips recall, senators urge review of FDA medical device oversight
Sens. Richard Durbin and Richard Blumenthal said the sleep apnea device maker “did nothing” while patients suffered.
By Susan Kelly • Dec. 14, 2023 -
Getty Images
Integra to buy J&J’s Acclarent for $275M
Integra said the purchase, which includes a portfolio of balloon dilation products for the sinuses and eustachian tube, would make it a market leader in ENT procedures.
By Elise Reuter • Dec. 13, 2023 -
Getty Images
Zimvie’s collaboration with Brainlab delivers 510(k) win for spinal fixation system
Amid recent struggles in its spine unit, Zimvie has been expanding its Brainlab partnership.
By Nick Paul Taylor • Dec. 13, 2023 -
Getty Images
The FDA approved 2 renal denervation devices. There are still questions about who will benefit.
The devices from Recor and Medtronic are intended to treat high blood pressure. An advisory panel backed the former, but recommended against approval of the latter.
By Elise Reuter • Dec. 13, 2023 -
Courtesy of Nevro
Activist investor takes stake in Nevro amid struggles to grow neuromodulation sales
Engaged Capital is opposed to Nevro going after acquisitions that may jeopardize its core business, Bloomberg reported Monday.
By Nick Paul Taylor • Dec. 12, 2023 -
Courtesy of Boston Scientific
Why heart device makers are investing in left atrial appendage closure
Medtronic and Johnson & Johnson are pursuing a market that leader Boston Scientific predicts could hit $6 billion by 2030.
By Susan Kelly • Dec. 12, 2023 -
Courtesy of Hologic, Inc.
Hologic promotes Essex Mitchell to COO
Mitchell joined Hologic as vice president of sales and commercial excellence for the GYN surgical division in 2017.
By Nick Paul Taylor • Dec. 11, 2023 -
Permission granted by Medtronic
Medtronic expands AI endoscopy partnership with Cosmo
The collaboration will focus on Cosmo Intelligent Medical Devices’ GI Genius module, which Medtronic distributes globally.
By Elise Reuter • Dec. 11, 2023 -
Courtesy of GE Healthcare
Advamed adds medical imaging division, names new board chair
The medtech association is bringing on staff from the Medical Imaging & Technology Alliance to lead the new division.
By Elise Reuter • Dec. 11, 2023 -
Courtesy of Becton Dickinson
BD receives 510(k) clearance for fingerstick blood test sample collection device
The clearance positions BD and partner Babson Diagnostics to support blood collection from community sites such as pharmacies.
By Nick Paul Taylor • Dec. 8, 2023
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