MySense Heart is yet again a path breaking solution that is designed to manage dynamic challenges of monitoring heart patients.
Medical equipment maker Opto Circuits (India) said it has received approval from the US health regulator to market a cardiac monitoring device in the American market.
The company's subsidiary, Cardiac Science Corporation, has received approval from US Food and Drug Administration to sell 'MySense Heart', a wearable cardiac monitor, in the American market, Opto Circuits said in a statement.
FDA clearance for the product was supported by a robust multi-centre clinical trial in the United States and New Zealand conducted in late 2011.
“MySense Heart is yet again a path breaking solution that is designed to manage dynamic challenges of monitoring heart patients. It augments our cardiac monitoring suite of products, expanding market addressability and revenues,” said Vinod Ramnani, chairman and managing director, Opto Circuits.
“We believe MySense Heart provides a clinically relevant economical solution to the healthcare market which hitherto did not exist. It also opens up opportunities for licensing, private labelling and direct-to-consumer retailing,” he added.
“MySense Heart is the first in a series of wearable, low-cost monitors being developed at Cardiac Science. “We expect to commercially release the product in early 2012 and intend to leverage this revolutionary platform to bring several new products to market,” said Dave Marver, CSC President and CEO.
In the late afternoon, Opto Circuits (India) Ltd was trading at around Rs204.85 per share on the Bombay Stock Exchange, 1.01% up from the previous close.