AdvaMed makes 510(k) recommendations; Study: Medtronic brain stimulation device holds promise;

> AdvaMed has submitted recommendations to the FDA on ways to improve the clarity and consistency of the 510(k) process. AdvaMed release

> Deep brain stimulation helped to reduce the frequency of a type of seizure in patients who hadn't responded to other treatments, according to data from a study published in the journal Epilepsia. Report

> The FDA has approved OrSense's NBM-200MP, a non-invasive oximetry and low signal oximetry sensor. The device provides continuous monitoring of oxygen saturation in states of hypovolemia, hypothermia and vasoconstriction or during open heart surgery. OrSense release

> San Diego's SpectraScience announced the FDA has conducted an unannounced inspection of its facility as part of the ongoing review of its Class III facility where the company manufactures WavSTAT Optical Biopsy System and LUMA Cervical Imaging System. Release

> AspenBio Pharma has completed patient enrollment for its AppyScore clinical trial designed to evaluate 800 patients suspected of having acute appendicitis. The study has now advanced to the data analysis phase. Aspen release

And Finally... The FDA has cleared the way for Envoy Medical to market a first-of-its-kind prosthetic hearing restoration device. Unlike hearing aids, the Esteem device does not use a microphone or speaker. Instead, it uses the natural ear drum to detect sounds and sends a clear message to the brain, via the auditory nerve. Report