CardiOx raises $650k to Pursue Regulatory Approvals in Europe and US

Dublin-based medical device startup CardiOx Corp has raised $650,000 out of $2 million in its current round of funding. Funding will go towards advancing the company’s efforts to gain regulatory approvals in Europe and the US for its non-invasive diagnostic tool for detecting right-to-left heart shunts.

Right-to-left heart shunts (a defect known as a patent foraemen ovale or PFO) can, in some people, lead to strokes, heart attacks and migraine headaches. Current methods of diagnosing shunts are very invasive and involve a probe being pushed down the throat to the heart. CardiOx’s approach combines an injection of dye with a diode sensor on the ear to determine the presence of a shunt. The device can also be used to verify that surgery succeeded in patching the hole.

CEO Larry Heaton, a medical device industry veteran who started with the company in April, said the company is targeting the second quarter of 2011 for European regulatory approval, known as the CE Mark, and third quarter for 510(k) approval from the US Food and Drug Administration.

For the more details, see the story in MedCity News.