Brain computer interface developer Paradromics on May 18, 2023, announced a $33 million Series A funding round as well as a “Breakthrough Device Designation” from the FDA.

The funding is reportedly for the company’s first-in-human clinical trial of the brain computer interface technology, named the Connexus^® Direct Data Interface (DDI).  The company states that “[t]he first application of the Connexus DDI is an assistive communication device that translates brain signals into speech and movement in real time, restoring social connection and enabling independent engagement with technology.”

The company reports that the funding round is being led by Prime Movers Lab, with the other investors including Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity.

The FDA describes the Breakthrough Device Designation program as a “voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”  The program is intended “to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.”

The company’s press release is available here, and more information on the Breakthrough Device Designation program from the FDA is available here.

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