Dozee, remote patient monitoring technology developer, on Thursday, announced that its contactless vital signs (VS) Measurement technology has received US FDA 510(k) clearance.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.
Dozee’s contactless sensor sheet is placed under the patient’s mattress to capture micro-vibrations produced by every heartbeat, respiration cycle, and body movement, using ‘Ballistocardiography’.
According to the company, the Dozee pod placed next to the patient’s bedside converts the vibration data into encrypted digital signals.
These signals are converted into vital signs like Heart Rate, Respiration Rate, Body Movements, etc. using proprietary cloud-based algorithms. The vital sign data is presented on Cloud-enabled Remote Monitoring Dashboard to healthcare providers, the company claimed on Thursday.
According to nursing and midwifery professional organizations, India falls short of the World Health Organization (WHO) recommended rate of 3 nurses per 1,000 population. Studies show that the country needs 4.3 million more nurses by 2024 to meet the WHO norms.
“Dozee can help bridge this massive gap by adopting automated patient monitoring systems across secondary and tertiary public hospitals. With its vision of ‘Make in India, Made for the World’—Dozee’s innovative technology aims to bridge the healthcare gaps in India and emerging markets like Africa and South East Asia,” the company said in a statement.
The company claims that Contactless remote patient monitoring can transform healthcare in India and globally.
“It can help to reduce workload and improve efficiency by enabling them to remotely and continuously monitor multiple patients with clinical accuracy at once. Along with enhanced patient safety, contactless RPM can enable the digitalization of vital data and drive operational efficiencies, especially with the growing shortage of nursing staff,” it stated.
Studies have shown that remote patient monitoring technology reduces the workload on nursing staff for monitoring patients in hospitals and clinics.
“When we started Dozee, our market assessment suggested that India imports 85-90% of the medical devices. Our dream was not just to make India Aatmanirbhar but to elevate India’s position in delivering world-class medical devices and technology globally. We are committed to Made in India, with global standards. USFDA is a gold standard when it comes to medical devices and algorithms. Dozee VS is our flagship contactless vitals technology that has received US FDA Clearance, an important milestone towards our vision #HarBedDozeeBed globally” said Gaurav Parchani, CTO and Co-Founder of Dozee in a statement.
For Patients, contactless technology improves the in-hospital experience by removing the need for wires, electrodes, and cuffs attached to the body, it stated.
