All articles tagged with #fda clearance
Meta announced at Meta Connect 2026 that it is introducing an FDA-cleared hearing enhancement feature for its AI glasses. The software, designed for users with mild to moderate hearing loss, will be available later this year for a one-time fee of $149.99 or via a Meta One subscription. It requires no prescription and can be set up at home, though it initially excludes Ray-Ban models.
The FDA has cleared Roche and Eli Lilly’s Elecsys pTau217 blood test to help identify Alzheimer’s disease–related brain changes in people 55 and older with cognitive decline; the biomarker test can run on more than 4,500 Roche analyzers in the United States and is intended to aid, not replace, diagnosis when used with other clinical information. European approval followed in May, and Labcorp and Quest Diagnostics plan to offer the test nationally, potentially broadening access as developers push for earlier detection and treatment. Experts warn that a positive pTau217 result is not a definitive diagnosis and must be interpreted alongside other data.
A large study of 2,684 older adults found that higher levels of the blood protein p-tau217 may predict Alzheimer’s risk up to a decade before symptoms, with about a 38% chance of cognitive impairment in five years and up to 78% in ten years for those with the highest levels. However, FDA clearance for p-tau217 tests currently covers only 55+ individuals with existing memory problems, and the test is used as a research tool rather than a clinical predictor for healthy people. While it can help identify candidates for drug trials and accelerate prevention research, there is no proven treatment to prevent Alzheimer’s yet; in the meantime, lifestyle factors like exercise, diet, sleep, and mental engagement remain the best available defense.
Some wearables, notably Apple Watch and Samsung Galaxy Watch, can screen for signs of sleep apnea (not diagnose it) using sensors and require setup with multiple nights of data; Withings' ScanWatch has FDA clearance for breathing disturbances but isn't marketed as a sleep-apnea alert; Garmin and Oura track breathing without FDA clearance; Fitbit and Whoop lack FDA-cleared respiratory features. If screening suggests apnea, see a doctor for evaluation.
Cadaver-derived adipose tissue products like AlloClae and Renuva are now used in cosmetic procedures such as butt lifts and breast enhancements. While legal and FDA-cleared in the US, the practice raises ethical questions about donor consent, the commodification of the dead, and potential impacts on organ donation attitudes, even as autologous fat transfer remains an alternative option.
Apple's Studio Display XDR now supports DICOM medical imaging presets and a Medical Imaging Calibrator, enabling radiologists to view diagnostic radiology images on a high-end monitor; the calibrator is pending FDA clearance and should be available in the US soon. Pre-orders begin March 4 with a March 11 launch. The display features mini-LED backlighting, 2,304 local dimming zones, 2000 nits peak brightness, a 1,000,000:1 contrast ratio, and a 120Hz refresh rate, with a starting price of $3,299, offering a more affordable option than many dedicated medical imaging monitors.
The FDA has approved Roche's Elecsys pTau181 blood test to help primary care physicians rule out Alzheimer's in adults over 55 showing symptoms, marking a significant step in early diagnosis and understanding of the disease, though further testing remains necessary for confirmation.
Apple Watch's new hypertension notifications, cleared by the FDA, will launch globally next week, using sensor data to monitor blood pressure signs passively and alert users to potential high blood pressure, aiming to help nearly half of undiagnosed cases and promote early health interventions.
Dexcom G7 CGM users can now monitor their real-time blood sugar data directly from an Apple Watch, using a dedicated Bluetooth connection for instant readings and alerts. This feature, available in the US, UK, and Ireland, requires an Apple Watch Series 6 or later and an iPhone running iOS 17. While it enhances convenience, it doesn't replace the need for a smartphone or Dexcom receiver for setup and comprehensive data analysis.
Intuitive Surgical's stock surged after receiving FDA clearance for its next-generation robotic surgery system, da Vinci 5, which promises improved accuracy, precision, and computing power compared to its predecessor, da Vinci Xi. The company plans to initially launch the system for a small number of U.S. surgeons before a broader release, aiming to gather additional data on its use. CEO Gary Guthart anticipates that the new system will lead to better patient outcomes, enhanced experiences for both patients and care teams, and reduced overall healthcare costs.
Intuitive, a leader in minimally invasive care, has received FDA clearance for its fifth-generation robotic system, da Vinci 5, designed to enhance surgical precision and patient outcomes. The system features improvements such as next-generation 3D display, force-sensing technology, and enhanced computing power, aiming to streamline workflow and increase surgeon comfort. Initially available to select U.S. customers, da Vinci 5 builds on the success of its predecessors and is expected to drive the future of robotic-assisted surgery.
The Samsung Galaxy Watch has received FDA clearance for a sleep apnea detection feature, set to be available in the third quarter of this year. The feature will track signs of moderate to severe obstructive sleep apnea by monitoring blood oxygen levels and notifying users through the Samsung Health Monitor app. While the company warns against using it as a replacement for traditional diagnosis and treatment, this new feature aims to help users proactively spot symptoms of sleep apnea and reduce health-related complications.
Google's Pixel 8 Pro has been updated to allow its temperature sensor to measure human body temperature, but the process is described as finicky and not user-friendly. The sensor, located in the rear camera array, requires users to hold the phone close to their forehead and swipe it over the temporal artery, making it difficult to gauge accuracy. Despite receiving FDA clearance, the feature includes disclaimers about accuracy and its inability to detect illness. Overall, the unconventional method and questionable accuracy raise doubts about the practicality and usefulness of this feature for the average user.
Intuitive Surgical has submitted for FDA clearance of its next-generation da Vinci 5 multiport surgical robot, with hopes for a 2024 launch. The company reported strong Q4 results, with revenue up 17% year-over-year. The da Vinci 5 will join Intuitive’s existing robotic surgical system portfolio, and the company is also in discussions with regulators in Japan and South Korea. Intuitive is gearing up for da Vinci 5 manufacturing and promises more details about its features and benefits after FDA clearance.
Withings has unveiled the BeamO, a $249.95 multiscope device that combines a thermometer, pulse oximeter, EKG, and stethoscope for at-home health monitoring. The device uses PPG sensors, electrodes, and a digital stethoscope to measure temperature, take EKG readings, and monitor blood oxygen levels and heart and lung health. Withings plans to launch the BeamO in June, but FDA clearance for EKG and AFib detection features may cause delays, as seen with previous products. Despite this, Withings continues to expand its at-home health platform, aiming to enhance telehealth capabilities with the BeamO.