A curated selection of wearable devices that have received FDA clearance for specific clinical indications, offering patients and providers reliable data for heart rhythm, blood pressure, glucose, and sleep analysis. These tools bridge the gap between consumer fitness tracking and medical-grade diagnostics.
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Features FDA-cleared ECG app for detecting atrial fibrillation and heart rate monitoring. It also includes sleep staging features and crash detection, providing a robust suite of health metrics for daily clinical oversight and wellness tracking.
The first smartwatch with an FDA-cleared built-in blood pressure monitor using oscillometric technology. It tracks activity and heart rate while providing accurate clinical-grade blood pressure readings directly from the wrist for hypertension management.
A continuous glucose monitor (CGM) cleared by the FDA to replace fingersticks for diabetes management. It provides real-time glucose data every five minutes to a receiver or smartphone, enabling precise glycemic control and trend analysis.
A hybrid smartwatch featuring an FDA-cleared ECG app for atrial fibrillation detection and a pulse oximeter for oxygen saturation monitoring. It combines analog aesthetics with clinical-grade sensors for comprehensive cardiovascular and respiratory health tracking.
A FDA-cleared wristband device designed for medical professionals to monitor seizure activity through electrodermal activity. It is widely used in clinical settings for epilepsy diagnosis and monitoring of autonomic nervous system responses.
A wearable sensor platform providing continuous vital sign monitoring for critical care and remote patient monitoring. It captures ECG, respiratory rate, heart rate, and movement data to alert clinicians to early signs of clinical deterioration.
A single-use, FDA-cleared patch for continuous ambulatory ECG monitoring up to 14 days. It is prescribed by doctors to diagnose arrhythmias like atrial fibrillation, offering higher data capture rates than traditional Holter monitors.
While not a traditional wearable, this portable diagnostic device is FDA-cleared for point-of-care testing. It allows for clinical-grade blood analysis including CBC and liver function tests in minutes, suitable for home or clinic use by healthcare providers.
A mobile patient monitor that attaches to a patient's gown or wristband, providing continuous cardiac, respiratory, and peripheral oxygen saturation monitoring. It is FDA-cleared for use in hospital and ambulatory settings to track patient vitals remotely.
A portable ECG device cleared by the FDA for six-lead cardiac monitoring. It allows users and clinicians to record, store, and share high-quality ECGs for the detection of arrhythmias, ischemia, and other cardiac conditions.
A pulse CO-oximeter that provides FDA-cleared monitoring of oxygen saturation, carbon monoxide, and methemoglobin levels. It is used in critical care to provide comprehensive hemoglobin and oxygenation data non-invasively.
An FDA-cleared sensor that attaches to inhalers to monitor usage patterns and environmental factors in asthma and COPD patients. It helps clinicians optimize treatment plans by providing data on medication adherence and trigger exposure.
A reusable SpO2 sensor designed for adult patients, providing FDA-cleared accuracy for oxygen saturation monitoring. It is widely used in clinical settings for reliable pulse oximetry during surgery, critical care, and general ward monitoring.
An FDA-cleared adhesive patch that monitors heart rate, respiratory rate, and SpO2 continuously. It is used in hospitals and home health settings to enable remote patient monitoring and early warning scores for clinical deterioration.
A disposable, FDA-cleared patch used for extended cardiac rhythm monitoring. It transmits ECG data in real-time to a monitoring center, allowing for the detection of intermittent arrhythmias that shorter-term devices might miss.
A wireless wrist blood pressure monitor that has received FDA clearance for accuracy. It syncs with a smartphone app to track trends over time, assisting users in managing hypertension through consistent home monitoring.
An FDA-cleared wearable sensor for continuous monitoring of ECG, respiration, and skin temperature. It is used in clinical trials and critical care to provide high-fidelity physiological data in a compact, wearable form factor.
A continuous glucose monitoring system cleared by the FDA for diabetes management. It measures interstitial glucose levels every minute and transmits data to a reader or smartphone, reducing the need for fingerstick calibrations.