NeoBeat Receives Medical Device Regulation Approval in India
The NeoBeat Heart Rate Monitor, which was designed and developed through 5+ years of research and collaboration with healthcare workers, has received medical device regulation (MDR) approval from the Indian Central Drugs Standard Control Organization (CDSCO) and is now available for sale.
Every day, more than 67,000 babies are born in India— and every minute, one of these newborns dies. In critical moments after birth, fast and reliable heart rate monitoring can make the difference between life and death for a newborn.
Based on ECG technology, NeoBeat takes only seconds to put on a newborn and delivers accurate heart rate readings quickly. This aids healthcare providers in making rapid decisions, enabling timely continuation of care, especially during newborn resuscitation. NeoBeat’s innovative technology does not require healthcare workers to dry the newborn first to ensure accurate, real-time monitoring.
Dr Arun Kumar Singh, Neonatologist, AIIMs Jodhpur: “By integrating NeoBeat into neonatal care in India, hospitals can enhance newborn resuscitation protocols, aligning with the latest global standards set by the Neonatal Resuscitation Program (NRP) and the American Academy of Pediatrics (AAP)."
The ability to monitor heart rate continuously from birth provides a new level of precision in newborn care, reducing unnecessary interventions while ensuring newborns receive immediate lifesaving support
Dr Rashmi Aradya, Director of Impact & Healthcare Education, India: “The introduction of NeoBeat in India is an important moment for Laerdal – and for newborns across the country. With this device, made available at an accessible price-point, healthcare providers will be better informed to make the right clinical decisions in the moment where it matters most."
We feel confident that the introduction will help save more newborn lives, as India works to reduce preventable neonatal deaths.
The NeoBeat Heart Rate Monitor was first launched into Tanzania in 2018. Since then, the device has been adopted in labor wards across the country and is one of the innovations included in the Safer Births Bundle of Care program, which has been proven to reduce newborn deaths by 40% after implementation in Tanzania. Globally, over 2000 NeoBeat Heart Rate Monitors are in use, including in countries like Ethiopia and Norway. In early 2025, the device also received CE certification under the EU MDR, paving the way for wider adoption globally.