ADI announces US FDA 510(k) clearance and the commercial launch of Sensinel

This innovative, compact wearable device represents a significant milestone as it marks the first FDA clearance ADI has achieved in its 59-year history. Designed as a non-invasive, remote management tool, the Sensinel CPM System efficiently captures vital cardiopulmonary measurements, offering a new approach to managing chronic diseases such as heart failure.

Patrick O’Doherty, Senior Vice President of Digital Healthcare at ADI, reflected on this achievement: “Since our founding, ADI has focused on accelerating breakthroughs that enrich lives through innovative products. By combining our wearable vital signs sensing and signal processing technology with cardiologist-inspired algorithms to precisely determine a congestive heart failure patient’s daily state of health, we developed the Sensinel CPM System. This innovative service-based product has the potential to open up several billion dollars of green-field market opportunity for ADI while improving patient care, streamlining clinician workflows, and reducing healthcare cost.”

With over six million Americans currently living with heart failure – a number expected to increase to nearly eight million by 2030 – and the annual cost to Americans reaching approximately $30 billion, with projections to rise to almost $70 billion by 2030, the need for effective management solutions has never been greater. Traditional methods have either been invasive or insufficiently sensitive and specific, limiting their impact on reducing costly hospital admissions.

The Sensinel CPM System introduces a next-generation solution for the remote and precise management of cardiopulmonary diseases. The system includes a wearable device that patients can easily apply and wear for just three to five minutes daily within the comfort of their homes. This device collects vital cardiopulmonary health data, which is then automatically uploaded to the Sensinel CPM Cloud Platform via a cellular connection – eliminating the need for a patient-provided Internet connection. Advanced analysis is conducted using ADI’s Sensinel CPM Intelligent Algorithms in the cloud to provide actionable insights for care teams.