Accelerometer meets FDA Class III implant device standards
STMicroelectronics has introduced the MIS2DH ULP 3-axis accelerometer designed for medical applications, including U.S. Food and Drug Administration (FDA) Class III implantable devices. ST has experience in developing custom motion sensors for leading medical manufacturers, and the MIS2DH distills this expertise into a product that can enable functions such as activity monitoring and posture sensing, for a wide range of medical applications.
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 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.
Until now, a major obstacle for SMEs wanting to develop medical devices has been the high cost 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 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, Certificate of Conformity (CoC) and ST's long-term longevity commitment.
The MIS2DH accelerometer 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.
"Medical researchers and electronics technology experts from companies of all sizes are interested in exploring new ways in which implantable devices could help enhance or prolong the life of people with chronic conditions, which will be an increasingly pressing problem with the world's ageing population," said Anton Hofmeister, General Manager, Custom MEMS Division, ST. "By combining our world-leading expertise in motion-sensing with a robust set of procedures for developing, manufacturing, and testing devices aimed at applications that meet the most stringent medical regulatory requirements, ST is contributing to important progress in this field by significantly lowering the cost and time-to-market barriers."
The MIS2DH is available now from ST.