Cognota receives US FDA approval for BP monitor device

Leading healthtech company Cognota Healthcare on Monday announced that the United States Food and Drug Administration (US FDA) has approved the company’s blood pressure monitor device- ‘COGNOHEALTH Blood Pressure Monitor’, marking the successful foray of the company into the medical devices segment.
The regulatory approval is a significant milestone for Cognota which can now export its blood pressure monitor devices to the US, Europe, and other overseas countries along with tapping the burgeoning Indian market.
The ‘COGNOHEALTH Blood Pressure Monitor’ device is powered by state-of-the-art technology that has been designed and developed by experts in Cognota’s R&D team. Approval from the US FDA, one of the apex healthcare regulatory bodies of the world, enables Cognota to expand its existing portfolio of healthtech solutions that include Remote Patient Monitoring (RPM), Teleconsultation Platform, and Smart ICU among others.
In a short span, Cognota has emerged as a market leader in multiple critical healthtech solutions by embedding cutting-edge software solutions in hardware devices. With such successful integration, its healthtech solutions are being increasingly adopted by several marquee healthcare providers across the world. US FDA approval is likely to provide further traction to the current momentum.
Estimates suggest that the blood pressure monitoring devices market size is likely to surpass around $2.66 billion by 2027 globally, at a CAGR of 8.56 per cent during the 2021 to 2027 period.
India is considered one of the top 20 markets for medical devices globally. The total market size is likely to touch $50 billion by 2025, according to some estimates. The sector has seen healthy growth owing to various initiatives of the Indian government including an emphasis on research and development (R&D) along with allowing 100 per cent FDI (Foreign Direct Investment) in the medical devices segment.
India is also a house to a huge caseload of high blood pressure patients. A recent report by the India Council for Medical Research showed that one in four adults in India suffers from hypertension and only 10 per cent of patients have their blood pressure under control. Cognota’s BP Monitoring device, therefore, has sound prospects in the Indian market in the coming years.
Commenting on the US FDA approval of Cognota’s BP Monitoring device, Sanjeev Dahiwadkar, Founder & CEO of Cognota Healthcare said, “Hypertension is a critical health problem across the world given the current lifestyle and expectations of people. This silent killer disease is also a huge problem in India after diabetes. Therefore, the US FDA approval of ‘COGNOHEALTH Blood Pressure Monitor’ device is a huge leap in Cognota’s efforts towards addressing this challenge. Built in-house by our R&D team, this approval also vindicates Cognota’s expertise in the successful integration of digital applications with advanced hardware components.”
“US FDA approval is a rigorous process that investigates all aspects of a healthcare device. Therefore, approval of the COGNOHEALTH Blood Pressure Monitor device is a feather in Cognota’s cap, which showcases Cognota’s technological depth, R&D bandwidth, and talent base,” he said.