Huxley Medical's SANSA Receives FDA Clearance for ECG Monitoring in Home Testing

Huxley Medical's SANSA Achieves FDA Clearance for Home Testing

Huxley Medical, Inc. has announced an important milestone with the recent FDA clearance of its SANSA® home sleep apnea test as a diagnostic ECG monitor. This breakthrough positions SANSA as the first home device capable of comprehensively identifying cardiac arrhythmias, including significant conditions like atrial fibrillation, all through a single chest-worn patch during sleep.

This regulatory approval is pivotal, strategically placing SANSA at the junction of two highly interrelated medical fields: cardiology and sleep medicine. Both fields serve a growing population of patients whose needs overlap, especially given the heightened demand for home diagnostic solutions. By gaining this clearance, Huxley Medical has addressed a crucial gap where home testing conventions often overlook detailed cardiac assessments traditionally available only through in-lab polysomnography.

Dr. Jodie Hurwitz, a cardiologist at the North Texas Heart Center and former president of the Heart Rhythm Society, highlighted the instrument's ability to bridge testing gaps. "SANSA has increased access to home sleep apnea testing while providing cardiac insights. This will help identify individuals who may require more extended monitoring or treatment," she noted. By providing actionable data, the SANSA device not only supports patients but equips healthcare professionals with critical information essential for effective and timely intervention.

As the healthcare industry shifts towards more patient-centric models, the SANSA home testing solution promises a more efficient workflow. Dr. Ravi Aysola, Director of Sleep Medicine at UCLA, emphasized the need for comprehensive ECG assessment, which SANSA now restores through its streamlined design and functionality. According to Dr. Aysola, this technology will allow sleep medicine practitioners to effectively capture arrhythmias in routine screenings, facilitating earlier interventions and improved patient outcomes.

Huxley Medical's Chief Scientific Officer, Dr. Brennan Torstrick, described this achievement as their fourth FDA clearance within a short span, indicating the company's ongoing commitment to enhancing SANSA's capabilities. "We are excited to continue executing our clinical and technology strategy in the coming years," he stated. The company plans to share real-world data from clinical implementations of SANSA focusing on arrhythmia detection in the context of home sleep apnea tests at upcoming electrophysiology conferences.

In summary, the FDA's approval of the SANSA home sleep apnea test marks a significant advance in medical technology. It not only enhances the diagnostic capabilities for sleep apnea but also integrates essential cardiac monitoring functions. By facilitating the on-site detection of cardiac rhythm disturbances, Huxley Medical enables doctors to implement timely interventions, thereby transforming the landscape of patient care and management significantly.

Huxley Medical remains committed to making healthcare solutions accessible and practical for all. With a strong foundation in biosensor development and AI-backed physiological signal analysis, the company is set to lead innovations that prioritize patient care globally.