FDA grants 510(k) clearance for electrographic status epilepticus diagnostic software

The FDA has granted 510(k) clearance to a medical device company for its software that diagnoses electrographic status epilepticus in adults.

According to a press release from Ceribell Inc., the clearance follows prior receipt of breakthrough device designation for the technology from the FDA, the second such designation granted to the company in the past 12 months.

Ceribell is a point-of-care EEG system that delivers real-time seizure monitoring and around-the-clock alerts, which allow for quick and precise treatment of patients with suspected nonconvulsive seizures. ClarityPro software employs machine learning to analyze EEG signals and generate bedside alerts, which enables clinicians to make bedside care decisions more rapidly, per the release.

CMS has granted New Technology Add-on Payment reimbursement for ClarityPro.

“These decisions from the FDA and CMS are further validation that Ceribell's clinical impact is significant for patients.” Ceribell co-founder and CEO Jane Chao, PhD, said in the release. "This dedicated reimbursement from CMS will also expand access to this vital technology to more Americans.”