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Medical equipment maker Opto Circuits (India) 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 the US Food and Drug Administration to sell ‘MySense Heart’, a wearable cardiac monitor, in the American market, Opto Circuits said in a statement today.
The device, which is used to monitor heart patients, would be launched early this year, it added.
Commenting on the development, Opto Circuits CMD, Mr Vinod Ramnani, said: “We believe MySense Heart provides a clinically relevant economical solution to the healthcare market which hitherto did not exist. It also opens up the opportunity for licensing, private labelling and direct to consumer retailing.”
USFDA clearance for the product was supported by a multi-centre clinical trial in the United States and New Zealand conducted in late 2011, the company said.
According to Cardiac Science Corporation President and CEO, Mr Dave Marver, the company expects to commercially release the product in early 2012 and intends to leverage the platform to bring several new products to market.
Shares of Opto Circuits ended the session today at Rs 204.85 on the BSE, up 1.01 per cent from their previous close.
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