MelMedtronics has announced the completion of its medical device registration with the Food and Drug Administration (FDA). The product line features the first tele-digital audiometer on mobile devices, the Tele-iAudiometer, which includes video communications, a full range of audiological tests, and built-in analytics.
The company’s iAudiometer™ is considered to be the first clinical iPad audiometer. According to MelMedtronics, they are able to leverage their proprietary software platform approach for tele-health to economically create targeted products with a customizable suite of options.
“Although the initial products are iOS-centric, we are in the process of down-selecting a set of EHR systems from which it can import or export patient and doctor information directly, including supporting the industry standard NOAH format,” said Gianna Lardaro, chief products officer at MelMedtronics.
The establishment registration and full list of products is available on the FDA website.
“The FDA Registration is a big step forward for MelMedtronics,” said David Holmes, PhD, CEO at MelMedtronics. “We also have a pending application for Health Canada and are in the process of renewing our ISO:13485 and our CE Mark for the EU.”
For more information on testing or acquiring registered products from the company, visit the MelMedtronics website.