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It will validate BrainEye's 60-second eye movement test to about 500 participants.
Clover Health reports first-time profitability on an adjusted EBITDA basis in the first quarter.
The company notified the SEC of a data breach after discovering an unauthorized party stole consumers' sensitive information, including patient health data.
The quarter marks the first time the company reported profitability on an adjusted EBITDA basis.
The company's Dream Sock, which received FDA 510(k) clearance in November, gathers real-time health readings, including a baby's sleep trends and pulse rate.
The company, which tailors cybersecurity offerings to health systems and providers, also appointed its first chief executive officer, Geyer Jones.
The Agency has qualified Apple's atrial fibrillation history feature as a medical device development tool, allowing it to be used in clinical trials.
Also, Clanwilliam has formally established its ANZ division.
The open-source gene editor is freely available to license for commercial use and ethical research.
The Agency alleges the company's CT and ultrasonography systems are noncompliant with good manufacturing requirements.