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SENSI GETS FDA CLEARANCE
The 1st of July 2011 has brought good news to the future of heart auscultation. Diacoustic Medical Device Company received notification that their Computer-Aided Auscultation device, Sensi has been approved and cleared by The United States Food & Drug Administration (FDA). This is a big milestone in the history of Diacoustic, something most companies struggle to achieve.
The Sensi Software device, a non-invasive medical device used to help doctors in their diagnosis of congenital heart defects (CHDs), received 510(k) clearance from the FDA meaning that the device is viewed as ‘valid, safe and effective’ to market and use on patients within the USA.
The procedure in getting an FDA clearance is rather that of a long and patient process as the regulations are extremely stringent. Substantial technical and clinical evidence must be provided to proof that the medical device lives up to the standards and quality of their regulations.
Sensi is now not only legal to market but is viewed as safe, reliable and effective for GP’s and Paediatricians to use on their patients. Medical Examiners can now be even more confident in Sensi when diagnosing their patients with pathological or physiological heart murmurs.
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