FDA clearance for sale of disposable cardiac monitoring device

The device, which monitors cardiac activity, is said to be small, lightweight and disposable that enables patients to wear it comfortably for an extended time.

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Cardiac Science Corporation, a subsidiary of India-listed Opto Circuits, has received US Food and Drug Administration (FDA) clearance for the sale of MySense Heart, a wearable Holter cardiac monitor.

Cardiac Science Corporation, a subsidiary of India-listed Opto Circuits, has received US Food and Drug Administration (FDA) clearance for the sale of MySense Heart, a wearable Holter cardiac monitor.

The device, which monitors cardiac activity, is said to be small, lightweight and disposable that enables patients to wear it comfortably for an extended time.

FDA clearance for the product was supported by a multi center clinical trial in the United States and New Zealand conducted in late 2011.

"MySense Heart augments our cardiac monitoring suite of products, expanding market addressability and revenues," Vinod Ramnani, Chairman and Managing Director, Opto Circuits.

The company expects to commercially release the product in early 2012 and intend to leverage this revolutionary platform to bring several new products to market, the release said.

Opto Circuits is a global medical-tech conglomerate that manufactures medical equipment and devices. Its share price rose 1.01 per cent to Rs 204.85 on the Bombay Stock Exchange on Wednesday.

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