FDA FDA 510(k) clearance: CORE 300 Digital Stethoscope — K261694, Jul 23, 2026. Applicant at approval: Eko Health, Inc. source ↗
Trial start —: Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes source ↗
Trial start —: Data Collection Using Eko Devices in a Clinical Setting source ↗
Trial start —: Data Collection Using Eko Digital Devices in a Clinical Setting source ↗
FDA FDA 510(k) clearance: Eko Foundation Analysis Software with Transformers (EFAST) — K251494, Aug 12, 2025. Applicant at approval: Eko Health, Inc. source ↗
Trial start —: Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence source ↗
Trial start —: Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope source ↗
Trial start —: Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG source ↗
Trial start —: Data Collection For Adventitious Lung Sounds Algorithm Using Eko Digital Devices in a Clinical Setting source ↗
Trial start —: Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope source ↗
Trial start —: Dialysis Access Monitoring Using a Digital Stethoscope-Based Deep Learning System source ↗
Trial start —: Real-World Evaluation of Eko Algorithms in a Point of Care Setting source ↗
Trial start —: Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting source ↗
Trial start —: Low Ejection Fraction in Single Lead ECG- Ochsner source ↗
Trial start —: Detection of Heart Conditions Using Artificial Intelligence source ↗
Trial start —: Low Ejection Fraction in Single Lead ECG source ↗
Trial start —: Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes source ↗
Upcoming milestones
2026-10 (ESTIMATED) · · Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence · NCT07270692
Dec 1, 2026 (ESTIMATED) · · Data Collection Using Eko Devices in a Clinical Setting · NCT07270744
Apr 1, 2027 (ESTIMATED) · · Data Collection Using Eko Digital Devices in a Clinical Setting · NCT07227376
May 31, 2027 (ESTIMATED) · · Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope · NCT07136623
May 31, 2027 (ESTIMATED) · · Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope · NCT05873387
May 31, 2027 (ESTIMATED) · · Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG · NCT07087613
Estimated primary completion per ClinicalTrials.gov. Dates move.
Heart Failure Monitoring With Eko Electronic Stethoscopes
Not listed
Terminated
Jul 6, 2020
Dec 14, 2020 (actual)
FDA records (last 2 years)
FDA 510(k) clearance: CORE 300 Digital Stethoscope — K261694, Jul 23, 2026. Applicant at approval: Eko Health, Inc. source ↗
FDA 510(k) clearance: Eko Foundation Analysis Software with Transformers (EFAST) — K251494, Aug 12, 2025. Applicant at approval: Eko Health, Inc. source ↗
Level (Entry/Mid/Senior/Executive) is estimated from the job title and required years of experience. Descriptions are short excerpts (about the first 60 words) of the posting plus skills picked out of it; use Read full posting for the complete text.