FDA: Page 15
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Courtesy of Samsung Electronics
Samsung wins de novo nod for watch that detects sleep apnea
The FDA created special controls that provide a path to market for other developers of over-the-counter devices.
By Nick Paul Taylor • Feb. 14, 2024 -
Permission granted by Senseonics
Senseonics gains expanded Medicare coverage for implantable CGM
Three Medicare Administrative Contractors will start covering the Eversense E3 CGM for people who only take basal insulin.
By Elise Reuter • Feb. 13, 2024 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Abbott Laboratories
FDA meeting document ‘generally supportive’ of Abbott Triclip: analysts
J.P. Morgan analysts noted the agency’s queries on safety but added the document has “simple voting questions” that “all lean towards approval.”
By Nick Paul Taylor • Feb. 12, 2024 -
Courtesy of Fresenius
Fresenius Medical Care brings dialysis technology to US with FDA clearance
The company plans to start a broad market launch next year and push to establish hemodiafiltration as the new standard of care.
By Nick Paul Taylor • Updated March 8, 2024 -
Courtesy of Insulet Corp.
Insulet wins CE mark for integration of insulin pump with Abbott CGM
The clearance positions Insulet to sell the integrated Type 1 diabetes product in Europe beginning in the first half of the year.
By Nick Paul Taylor • Feb. 8, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s spinal cord stimulators approved for non-surgical back pain
FDA backing for the Wavewriter SCS systems allows the company to challenge Abbott and Nevro.
By Nick Paul Taylor • Feb. 7, 2024 -
Sarah Silbiger via Getty Images
Hologic wins FDA clearance for AI-enabled cervical cancer screening system
The product creates digital images of Pap test slides and uses an AI algorithm to identify cells for review.
By Nick Paul Taylor • Feb. 5, 2024 -
Wavebreakmedia via Getty Images
FDA panel recommends new standards for pulse oximeters amid bias concerns
Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.
By Elise Reuter • Feb. 5, 2024 -
Permission granted by Veeva Systems
FDA to reclassify most high-risk IVDs, easing path to clearance
The effort comes ahead of the regulator’s plan to finalize a rule that would expand its oversight of laboratory-developed tests.
By Susan Kelly • Feb. 5, 2024 -
Retrieved from Food and Drug Administration.
Cardinal Health expands recall of Monoject syringes amid compatibility problems
The company said there have been no reports of patient deaths, but noted there is a risk of serious injury or death.
By Nick Paul Taylor • Feb. 5, 2024 -
Sara Silbiger via Getty Images
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 -
Patrik Stollarz / Staff via Getty Images
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 -
JohnnyGreig via Getty Images
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 -
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 -
deliormanli via Getty Images
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 -
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
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