Medical Devices: Page 47
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3 bellwether companies to watch as medtech earnings season begins
J&J, Intuitive Surgical and Abbott kick off this week with fourth-quarter reports.
By Nick Paul Taylor • Jan. 22, 2024 -
Courtesy of Abbott
Abbott starts study of PFA device in humans, targets 2024 US trial
RBC analysts predict Volt could launch in the U.S. as early as 2026.
By Nick Paul Taylor • Jan. 19, 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 -
Sarah Silbiger via Getty Images
FDA authorizes record number of new devices in 2023
The FDA shared the figures in the CDRH’s annual report, which also features updates on its work on MDUFA V goals.
By Nick Paul Taylor • Jan. 18, 2024 -
Justin Sullivan via Getty Images
Apple to sell watches without pulse oximetry after ban of original design takes effect
A court Wednesday denied Apple’s request for an extended stay on an import ban of its smartwatches, after the International Trade Commission found the products infringed Masimo’s patents.
By Susan Kelly • Jan. 18, 2024 -
Courtesy of Dermasensor
Dermasensor wins FDA clearance for AI-enabled skin cancer detection device
A study found the sensitivity of the device was 96%, compared with 83% for primary care physicians.
By Nick Paul Taylor • Updated Jan. 22, 2024 -
Courtesy of 3M
Nuvasive’s former CEO joins 3M spinoff
Chris Barry will become group president of the Medical Solutions Division for 3M’s healthcare business.
By Elise Reuter • Jan. 17, 2024 -
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Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools
The de novo classifications cover software for detecting a lung condition and assessing dementia risk.
By Nick Paul Taylor • Jan. 17, 2024 -
Sarah Silbiger via Getty Images
FDA warns of shoulder implant risks after Exactech declines to start voluntary recall
Agency officials advised healthcare professionals against implanting Equinoxe Shoulder Systems packaged in defective bags.
By Nick Paul Taylor • Jan. 17, 2024 -
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Integer acquires Pulse Technologies for $140M
Pulse specializes in the micro machining of components for medical devices used in markets such as structural heart.
By Nick Paul Taylor • Jan. 16, 2024 -
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EssilorLuxottica integrates tech into glasses to target hearing loss market
The glasses feature microphones, speakers and algorithms to amplify speech, but the technology is hidden in the frame.
By Nick Paul Taylor • Jan. 16, 2024 -
Getty Images
Apple, locked in patent fight with Masimo, redesigns smartwatch
The tech giant could bring to market watches without a pulse oximetry feature to avoid an ITC ban on sales of versions now on the market.
By Susan Kelly • Jan. 16, 2024 -
Retrieved from Wikimedia Commons on December 15, 2021
UK shares roadmap for creation of new medtech regulatory framework
The MHRA plans to have the “core elements” of the new framework for medical devices in place by the next year.
By Nick Paul Taylor • Jan. 12, 2024 -
Courtesy of Resmed
Resmed’s magnetized masks linked to 6 patient injuries, FDA says
The company contacted customers in November after determining magnets should be kept away from active implants and metallic medical devices.
By Nick Paul Taylor • Jan. 12, 2024 -
Permission granted by Intuitive Surgical
Intuitive CEO: Strong robot placements offset bariatric surgery slowdown
Speaking at the J.P. Morgan Healthcare Conference, CEO Gary Guthart said the robotics company is also seeing strong growth in general surgeries.
By Susan Kelly • Jan. 11, 2024 -
Courtesy of Masimo
Masimo’s preliminary Q4 results, 2024 outlook exceed analyst expectations
Analysts see the update as evidence Masimo may be rebounding after failing to meet their expectations earlier in the year.
By Nick Paul Taylor • Jan. 11, 2024 -
Permission granted by Abbott
Abbott CEO talks diabetes market, device pricing at J.P. Morgan conference
CEO Robert Ford is “very confident” in Abbott’s ability to pass $10 billion in sales of its Libre continuous glucose monitor products by 2028.
By Elise Reuter • Jan. 10, 2024 -
Courtesy of https://www.livanova.com/advanced-circulatory-support/en-us
Livanova to close loss-making circulatory support business
Stifel analysts expressed support for the decision, predicting it will benefit revenue growth and profitability, and increase focus.
By Nick Paul Taylor • Jan. 10, 2024 -
Sarah Silbiger via Getty Images
GE Healthcare notice about ventilator formaldehyde risk triggers FDA alert
The company warned customers about elevated levels of the toxic gas when its EVair or EVair 03 optional compressors are used in certain conditions.
By Nick Paul Taylor • Jan. 10, 2024 -
Courtesy of Nevro
Nevro laying off 63 people to strengthen financial position
The job cuts affect roles across corporate, sales and marketing, and operations.
By Nick Paul Taylor • Jan. 10, 2024 -
Sara Silbiger via Getty Images
J&J’s Megadyne restricts use of electrodes over burn risk, triggering Class I FDA notice
The J&J unit limited the use of the product in children after receiving reports of burn injuries that could be particularly harmful to them.
By Nick Paul Taylor • Jan. 9, 2024 -
Permission granted by Medtronic
Medtronic focused on delivering durable revenue and profit growth
“Our top priority is restoring our earnings power, full stop,” CEO Geoff Martha said Monday at the J.P. Morgan Healthcare Conference.
By Susan Kelly • Jan. 9, 2024 -
Courtesy of Boston Scientific
Deep Dive5 medtech trends to watch in 2024
From the M&A outlook and tough year-over-year comparisons to emerging markets like pulsed field ablation, here are the top medical technology trends to watch this year.
By Ricky Zipp • Jan. 9, 2024 -
Permission granted by Dexcom
Dexcom plans to launch new CGM this summer for people who don’t take insulin
The company also shared earnings expectations for 2024 at the J.P. Morgan Healthcare Conference.
By Elise Reuter • Jan. 9, 2024 -
Retrieved from Axonics on August 22, 2023
Boston Scientific to buy Axonics for $3.7B to gain incontinence treatment
The acquisition provides a high-growth addition to Boston Scientific’s urology business, analysts said.
By Susan Kelly • Jan. 8, 2024 -
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US hospitals report increased procedure volumes, spending outlook in Q4 survey
Truist analysts wrote that Medtronic, Boston Scientific and Edwards Lifesciences could benefit from rising cardiology volumes, while Intuitive Surgical may benefit from improved capital spending.
By Nick Paul Taylor • Jan. 8, 2024
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