Vittamed’s Non-Invasive Intracranial Pressure and Cerebrovascular Autoregulation Monitors Cleared in EU (VIDEOS)

Vittamed out of Carlisle, MA received European CE Mark approval for its non-invasive intracranial pressure meter and non-invasive cerebrovascular autoregulation monitor. The Vittamed 205 intracranial pressure monitor works by applying pressure to the tissue surrounding the eye using a special pressure cuff. A Doppler ultrasound transducer plac (Read more...)

FDA announces closer scrutiny of lab-developed tests, companion diagnostics

In an effort to validate the accuracy, consistency and reliability of diagnostic testing, the FDA has announced its intent to issue a final guidance document on the development, review and approval of companion diagnostics. The agency has also alerted Congress that it will publish a risk-based oversight framework for laboratory-developed tests, according to an agency press release. “Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” FDA commissioner Margaret A. Hamburg, MD, said in (Read more...)