Medical-grade motion sensor to commoditize implantable devices
Implantable medical devices such as cardiac pacemakers, ICDs (Implantable Cardioverter Defibrillator), and neurostimulators have been successfully used for many years to prolong the lives of patients with heart problems or to make life better for people with chronic pain conditions.
Today, there is a growing interest in the medical world in exploring how new implantable devices could help treat other chronic problems such as high blood pressure, epilepsy, and tremor-related conditions. For most of these applications, an embedded accelerometer capable of measuring the activity and posture of the patient is important to manage the stimulus delivered by the implantable device and therefore to improve the effectiveness of the treatment and the wellbeing of the patient.
Till now, a major obstacle for SMEs (Small and Medium Enterprises) wanting to develop innovative new medical devices has been the high costs associated with custom-designed sensors and obtaining FDA certification. The MIS2DH addresses this problem by combining a 3-axis mechanical element and an integrated electronic circuit in a single package, along with a set of collaterals required by customers seeking FDA Class III approval:
• Dedicated manufacturing and testing flow, including additional checks, screening and process control;
• Guaranteed retention of production records for more than 10 years;
• Product-change management and notification aligned with medical standards;
• Each batch is shipped with a Certificate of Conformity (CoC);
• Long-term longevity commitment.
The very low power MIS2DH accelerometer (down to 2μA in low-power mode from a 1.71 to 3.6V operating voltage) has been developed and produced in full compliance with the rules of ST’s medical domain, a self-regulation that ST adopted in 2012 to secure the development and manufacturing flow for products intended for use in sensitive medical applications. It offers ±2g/±4g/±8g/±16g selectable full-scale and 8-, 10- and 12-bit operating modes, supporting an output data rate from 1Hz to 5KHz.
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