FDA Proposes New Guidance To Address Pulse Oximeter Inaccuracies Due to Skin Tone
Federal regulators are calling for larger pulse oximeter clinical studies, to ensure manufacturers examine the accuracy of the devices on all skin tones.
Tag Archives: Medical Device
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FDA Report Details How Agency Made Medical Devices Safer in 2023
Further improvements to medical device quality, surveillance and the medical device recall program are planned by the FDA throughout 2024.
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FDA to Hold Public Hearing on Addressing Pulse Oximeter Inaccuracies
Concerns about the safety and accuracy of pulse oximeters for people with darker skin will be reviewed by health experts at a panel advisory meeting in February 2024
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FDA Finds No Risk of Death Linked to Paclitaxel-Coated Balloons and Stents
Prior warnings indicated that paclitaxel coated implantable devices may increase risk of death by up to 50%, but agency indicates the information is not supported by current data
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FDA Issues Letter To Doctors About Issues with NuVasive Precice Limb-Lengthening Devices
Prior warnings and recalls of the limb-lengthening implants have raised concerns about biocompatibility problems, leading the FDA to warn doctors to remove the devices after one year.
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FDA Warns of Cybersecurity Vulnerabilities in Certain DNA Sequencing Devices
Several models of Illumina DNA sequencing devices have cybersecurity flaws that could allow hackers to access patient information, warns FDA
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Coolsculpting Side Effects Cause Disfiguring PAH Complications For Some Users: Report
Doctors say they see much higher rates of CoolSculpting side effects, such as abnormal bulges, than indicated on the device's warning label.
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FDA Introduces Cybersecurity Modernization Plan to Prevent Hacking of Medical Devices
A growing rise in cybersecurity hacking attempts have been identified since the beginning of the COVID-19 pandemic, leading to increased attention on preventative measures
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Sterigenics Lawsuit Goes Before Jury Over Medical Sterilization Plant Pollution
More than 700 Sterigenics lawsuits have been filed over claims the company knowingly released toxic chemicals into the air near its facilities in Illinois and Georgia.
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Pediatric Heart Devices Often Approved By FDA Without Clinical Trials Involving Children: Study
Manufacturers often use data from adults to determine the safety and efficiency of pediatric heart devices, researchers found.
