Functional Neuromodulation Ltd. is looking to help those suffering from mild Alzheimer's disease. To that end, it recently disclosed that it has kicked off the global ADvance II Study (NCT03622905), a pivotal clinical trial to assess deep brain stimulation (DBS) in these patients. Read More
The FDA's Center for Devices and Radiological Health has released yet another draft guidance dealing with medical device premarket programs with the release of a draft guidance for the accreditation scheme for conformity assessment. The draft frequently references independent standards for assessing device performance and safety, thus bringing regulatory harmonization one step closer to a practicable reality. Read More
The U.S. Department of Defense's Defense Advanced Research Projects Agency (DARPA) has tapped Tempe, Ariz.-based startup Inanobio Inc. to build an epigenetic sequencer capable of detecting exposure to weapons of mass destruction (WMDs). The four-year contract, valued at up to $5.4 million, is part of a larger DARPA $27.8 million contract awarded to a consortium led by the Icahn School of Medicine at Mount Sinai Health System in New York under the agency's Epigenetic Characterization and Observation (ECHO) program. Read More
