FDA clears Cardiac Insight's Cardea Solo wearable ECG sensor

Cardiac Insight announced Thursday that the FDA cleared its Cardea Solo device, making it "the first wearable electrocardiogram (ECG) sensor giving physicians immediate access to complete cardiac arrhythmia data and analysis." CEO Brad Harlow remarked that the "affordable, patient-friendly and nonintrusive device" is designed to improve healthcare for patients with arrhythmia.

According to Cardiac Insight, the device offers improved reporting and analysis of heartbeat-to-heartbeat data, while the design and ease of use encourage improved patient compliance. The company said it expects the ECG sensor's capabilities "to enhance efficiencies in mean time to cardiac diagnosis and treatment, which can contribute to improved conditions for patients and reduce healthcare system costs."

Cardiac Insight explained that the small lightweight device, which is lead-less, water-resistant and single-use disposable, can be worn under a patient's clothing for up to seven days, allowing them to maintain normal daily activities while the sensor records ECG data and symptoms. The physician office software analyses the recorded data "to provide physicians with full-disclosure of all data" for immediate review and action, a process that previously required days or weeks, Cardiac Insight noted. The software also provides ECG trace review tools and a summary report of heart rhythms. "For the first time, the sensor technology eliminates the need for outsourcing to costly and time-consuming third-party service centres," the company added.

Cardiac Insight has raised $2 million to develop the device, with Harlow noting that the funding round closed in December, and included existing partner Welch Allyn, along with several private investors. Cardeo Solo could reportedly be priced at $20. 

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