Healthcare technology company Aidar Health is looking to grow in Baltimore after receiving regulatory approval in the U.S. and Europe for its handheld device that monitors vital signs.
The company received 510 (k) clearance from the U.S. Food and Drug Administration earlier this month for the device, called MouthLab. That means it is allowed to be marketed in the U.S. In February, it received CE Mark approval, which allows it to be sold in Europe. Regulatory clearance is a key milestone for companies working in healthcare. Along with allowing the device to be sold, CEO Sathya Elumalai said the approvals demonstrate that is safe and effective.
“We really wanted to focus on building the next best thing that came out of Baltimore, but also something that is safe and reliable from a device standpoint,” he said. “I really wanted to feel confident that I could give this device to my mom because she is the inspiration behind the company.”
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