FDA: Page 14
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FDA publishes final rule to harmonize quality system requirements with global standard
The agency extended the transition timeline from one to two years, pushing back the effective date to 2026.
By Nick Paul Taylor • Feb. 1, 2024 -
Joe Raedle/Getty Images via Getty Images
Califf backs increased LDT oversight despite industry opposition
At a Wednesday event, the FDA commissioner named the laboratory-developed test proposal as a top priority and addressed questions on AI.
By Ricky Zipp • Feb. 1, 2024 -
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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 -
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FDA receives more reports of deaths linked to Philips’ recalled respiratory devices
From the start of July to the end of September last year, the agency received more than 7,000 reports that contained 111 deaths.
By Nick Paul Taylor • Feb. 1, 2024 -
Sarah Silbiger via Getty Images
FDA extends deadline for comments on role of digital health in diabetes detection
The agency is seeking answers on how digital health technologies could be used in the detection of prediabetes and Type 2 diabetes.
By Nick Paul Taylor • Jan. 31, 2024 -
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The top medtech trends in 2024
Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.
By MedTech Dive Staff • Jan. 31, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips stops selling sleep, respiratory devices in US due to FDA consent decree
The order is now being finalized ahead of its submission to a U.S. court for approval.
By Nick Paul Taylor • Jan. 29, 2024 -
Sarah Silbiger via Getty Images
Absolutions receives FDA breakthrough designation for abdominal wall closure device
The device is designed to reduce the risk of hernia by distributing suture tension over a large area of tissue.
By Nick Paul Taylor • Jan. 26, 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 -
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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 -
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FDA, CMS defend plans to increase oversight of laboratory developed tests
In a joint letter Thursday, leaders from the agencies outlined why they are opposed to using the Clinical Laboratory Improvement Amendments to address concerns with LDTs.
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 -
Alex Wong/Getty Images via Getty Images
GAO to review FDA’s oversight of medical device recalls
The government watchdog has accepted a request made in December 2023 by Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn.
By Ricky Zipp • 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 -
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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 -
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 -
Sara Silbiger via Getty Images
FDA adds vaporized hydrogen peroxide as sterilization alternative to EtO
The change supports the agency's efforts to reduce the use of ethylene oxide and strengthen the medical device supply chain.
By Elise Reuter • Updated Jan. 11, 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 -
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 Nanowear
Nanowear gets FDA clearance for undergarment that estimates blood pressure
The company’s continuous blood pressure monitor allows clinical investigators to remotely capture data on patients.
By Nick Paul Taylor • Jan. 5, 2024 -
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Renovos secures FDA breakthrough status for bone graft alternative
When injected, Renovite acts as a scaffold for cells and helps localize and retain molecules that stimulate healing.
By Nick Paul Taylor • Jan. 5, 2024 -
Sarah Silbiger via Getty Images
FDA warns providers not to buy or implant Synovo’s total hip system
Last year, the FDA sent a warning letter to Synovo after finding that its femoral resurfacing cup had been “significantly changed or modified.”
By Nick Paul Taylor • Jan. 4, 2024 -
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
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