The FDA is proposing new rules that would require companies making pulse oximeters to conduct larger studies with more diverse patient populations. This comes after studies suggested that darker skin pigmentation can sometimes lead to inaccurate readings from these devices, which are crucial for monitoring oxygen levels in patients.
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The FDA’s draft recommendations, which are not binding, would make several changes to how companies are expected to test their devices, including:— Including at least 25% of patients with darker skin complexion in each study; The FDA recommendations apply to only professional oximeters used in hospitals, doctor’s offices and other medical settings. The government doesn't regulate over-the-counter oximeters, which it considers “general wellness” devices.
FDA Pulse Oximeters Accuracy Patients Of Color COVID-19
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