Device approvals, testing, diagnostics, safety alerts, and technology updates.
The FDA says a Class I recall covers TRUE METRIX blood glucose monitoring systems because an E-5 error code can mean either very high blood sugar or a strip problem. That mix-up can delay treatment or lead to the wrong response, so users should know the warning signs, confirm what device they have, and check the latest FDA guidance.
The FDA is using Early Alerts to warn the public faster about some potentially serious medical device problems. If a device, kit, or lot you use is named in a notice, the safest next step is to read the FDA and manufacturer instructions closely and follow the device-specific guidance.
A new JAMA Internal Medicine estimate puts CT scan safety back in focus. Here’s what the model found, what it did not prove, and what to ask before imaging.
The FDA says phone settings or software problems can disrupt diabetes device alerts, raising the risk of missed low blood sugar warnings and delayed treatment.
FDA-authorized medical AI is already common in scans and workflow tools. Here’s what authorization means, what it does not, and what patients should ask.
Some medical AI tools are FDA-regulated, but authorization is not a promise of equal accuracy in every clinic. Here’s what patients should ask.
A March 4, 2026 FDA update says families should use standard choking first aid first, not reach for a suction device. Here’s how to recognize severe choking and what to do for adults, children, and infants.
The FDA has classified a recall for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors as Class I, its most serious recall type. The issue is falsely low glucose readings from some sensor lots. Here is what is affected, what is not, how to check your sensor, and what to do if a reading does not match how you feel.
New Alzheimer’s blood tests are becoming part of clinical care in the United States, but they are not simple screening tools for anyone worried about forgetfulness. Here’s what the FDA cleared, what specialists recommend, and what families should ask before treating a blood result as proof of Alzheimer’s disease.
Stryker’s March 2026 cyberattack is a reminder that patients can feel the effects of a vendor disruption through shipping delays, manual workarounds, and some rescheduled procedures, even when their hospital was not directly hacked.
A new Nature Medicine study suggests a blood-based model may help estimate when Alzheimer’s symptoms could begin, but the research is not a consumer screening test. Here’s what the study actually found, what U.S. patients can access now, and why memory symptoms still need a full medical workup.
Roche’s FDA-cleared pTau181 blood test brings Alzheimer’s biomarker testing closer to everyday care, but right now it is mainly for adults 55 and older who already have cognitive symptoms, and a positive result still usually needs more workup. ([accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252163))
AI tools are increasingly used in imaging, diagnostics, and clinical decision support. Here’s how the FDA regulates artificial intelligence as medical devices, what Software as a Medical Device (SaMD) means, and what patients should know about safety, updates, and limits in 2026.
Artificial intelligence is increasingly used in imaging, heart monitoring, and disease screening. Here’s how the U.S. Food and Drug Administration regulates AI-enabled medical devices — and what that oversight means for patient safety, transparency, and trust.
The FDA continues to monitor rare cancers linked to breast implants, including BIA-ALCL and emerging reports of BIA-SCC. Here’s what patients need to know about symptoms, risk levels, informed consent, and insurance coverage.
OTC hearing aids are now widely available for adults with mild to moderate hearing loss. Here’s what the FDA requires, how they differ from prescription devices, what traditional Medicare does and does not cover, and when a medical exam is still essential.
AI tools are increasingly used in U.S. hospitals and clinics, but not all of them are regulated the same way. Here’s how the FDA oversees AI-enabled medical devices, what clearance really means, and what patients should ask when AI is involved in their care.
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