Eko Health developed the device, which has received 501(k) clearance from the FDA.
The FDA granted 501(k) clearance to Eko Health’s Core 500 digital stethoscope. The device comes equipped with noise cancellation, multiple audio filter modes, and up to 40x sound amplification. The stethoscope also uses in-ear speaker technology to filter sound and reduce background noise.
The Core 500 is also able to integrate with Eko’s live streaming platform, allowing for virtual teams to listen in along with the attending healthcare provider. These teams can also record, analyze, and share the data. Eko Health also uses Sensora, a cardiac disease sensing platform, which uses machine learning technology to symptoms of various heart conditions and diseases, including AFib, bradycardia, and tachycardia.
In a press release, Eko Health co-founder and CEO Connor Landgraf said, “A few years ago, we set out to reimagine the most ubiquitous medical tool. We've spent countless hours designing, testing, and refining to produce a flagship product that we're very proud of and has high clinical value–the CORE 500™ is the result. (This) represents a major leap forward in digital stethoscope technology. When paired with our powerful AI algorithms, it can help detect leading indicators of heart disease in seconds, greatly assisting healthcare professionals in identifying various cardiac conditions with increased accuracy and confidence. This innovative feature aims to save time during routine exams and improve patient outcomes."