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31. 01.2019

FDA sets March dates for microbiology, neurology device panel meetings

The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases.

In the microbiology devices panel meeting, slated to be held March 8, a committee of microbiology device experts will discuss and make recommendations regarding novel or alternative approaches to clinical studies and devices intended to detect Human Papillomavirus nucleic acid, according to the release.

“These approaches will take into consideration scientific data generated since the approval of the first High Risk HPV screening device in 2003 as well as the effects of HPV vaccination on clinical studies of devices for HPV detection,” the FDA wrote in its posting.

Topics slated to be discussed include clinical study design and comparator methods, as well as potential changes to the HR HPV device indications for use considering “continually evolving cervical cancer screening guidelines,” according to the release.

During its neurological devices panel, slated to be held March 21, a committee will explore the FDA de novo application for Israel-based Neuronix’s NeuroAD Therapy System, according to the FDA release. The system is intended to provide concurrent neurostimulation and cognitive training to treat mild to moderate Alzheimer’s dementia.

The company is currently engaged in a multi-site clinical study of the system in the U.S. and Israel. The NeuroAD system and its associated procedure combines transcranial magnetic stimulation with custom-tailored cognitive exercises, according to the company’s website.

Both panels are slated to meet between 8:00 a.m. and 5:00 p.m. EST at the Gaithersburg, Md.-based Hilton Washington, according to the postings.

Yesterday, the FDA announced that it tentatively plans to hold a meeting of the General and Plastic Surgery Devices Panel, March 25-26. The meeting will take place at the FDA’s headquarters in Silver Spring, Md

Source: MassDevice