Suzhou Good-Ark Electronics, a renowned semiconductor and sensor manufacturer, announced on November 4 that its medical-grade PIR sensor GA-PIR-M100 has obtained FDA 510(k) clearance and CE MDR certification, becoming the first Chinese PIR sensor product to enter the European and American medical device markets. The product has secured a 50,000-unit order from Philips Healthcare, to be used in intelligent hospital bed monitoring systems.
The GA-PIR-M100 is designed for non-invasive monitoring of patient movement and posture in hospital wards and nursing homes. It features a high-precision detection algorithm that can identify subtle movements such as turning over and sitting up, with a false negative rate of less than 0.1%. The sensor adopts a fully enclosed encapsulation process to meet the IP67 waterproof and dustproof standards, and can withstand ethylene oxide sterilization. “Medical-grade sensors have strict requirements on reliability and stability,” said Lin Hong, Good-Ark’s Sensor Business Unit Manager. “We spent 2 years on R&D, conducting 100,000+ hours of aging tests. The cooperation with Philips will help us expand into the global medical sensing market, which is expected to contribute 15% of our sensor business revenue in 2026.”