Medical Devices: Page 25
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Sascha Steinbach via Getty Images
How Masimo forced Apple to redesign its smartwatches
In a long-running patent dispute, Masimo has compelled the tech giant to remove the pulse oximetry function of certain Apple Watches.
By Susan Kelly • Jan. 26, 2024 -
Courtesy of Cook Medical
Cook Medical sells ear, nose and throat devices to C2Dx
The transaction completes Cook’s divestiture of its otolaryngology, head and neck surgery product lines.
By Nick Paul Taylor • Jan. 26, 2024 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Permission granted by Abbott
Abbott gets approval for new rechargeable deep brain stimulation system
The decision comes just weeks after Medtronic received approval for its latest rechargeable device.
By Elise Reuter • Jan. 25, 2024 -
Sara Silbiger via Getty Images
FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain
The reorganization establishes new divisions at the Office of Strategic Partnerships and Technology Innovation to account for its growth since 2019.
By Nick Paul Taylor • Jan. 25, 2024 -
Courtesy of Intuitive Surgical
Robot reveal: Intuitive submits 510(k) for next-generation system
The new surgical robot will have 10,000 times the processing power of the current da Vinci model, CEO Gary Guthart said on the company’s fourth-quarter earnings call.
By Susan Kelly • Jan. 24, 2024 -
Courtesy of Abbott
Abbott says all four segments stronger than pre-pandemic
CEO Robert Ford said investing in its base business using COVID-19 testing revenues was “absolutely the right strategy.”
By Elise Reuter • Jan. 24, 2024 -
Carl Court via Getty Images
European Commission proposes delays for IVDR to prevent supply disruption
Officials are planning to give manufacturers another 31 months to get tests certified under the In Vitro Diagnostic Medical Devices Regulation.
By Nick Paul Taylor • Jan. 24, 2024 -
3M on track to complete healthcare spinoff in first half of 2024
The healthcare leadership team will share more details as the completion of the transaction approaches.
By Nick Paul Taylor • Jan. 24, 2024 -
Courtesy of Edwards Lifesciences
Edwards risks TAVR market share slip amid challenges from Abbott, Boston Scientific: survey
Cardiologists predicted Edwards’ market share may erode slightly in the next two years, according to a survey commissioned by Leerink Partners.
By Nick Paul Taylor • Jan. 23, 2024 -
real444 via Getty Images
Deep DiveOrthopedics leaders watch procedure backlog, new technologies in 2024
J&J, Medtronic and Smith & Nephew executives and orthopedic surgeons said they expect more procedures to move outpatient, while questions about pricing and procedure backlogs loom over the medical technology industry.
By Elise Reuter • Jan. 23, 2024 -
Courtesy of Medtronic
Medtronic’s closed-loop neuromodulation device cuts overstimulation in trial
Most participants reported a significant reduction in overstimulation compared to open-loop spinal cord stimulation.
By Nick Paul Taylor • Jan. 22, 2024 -
Mario Tama via Getty Images
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 -
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 -
Stock via Getty Images
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 -
Maks_Lab via Getty Images
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 -
Kobus Louw via Getty Images
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 -
Eric Thayer via 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
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