July 5, 2018
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.
In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the...
May 23, 2018
New York and Palo Alto, California-based MemoryMD have recently received FDA clearance for a disposable 19-channel EEG headset, called the NeuroCap.
Along with the NeuroEEG, a wireless amplifier worn around the arm that transmits to computers and cloud-based databases via Bluetooth that was approved in February, the company is now preparing to launch its full offering as a convenient approach to...
April 6, 2018
In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.
Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...
February 20, 2018
New York and Palo Alto, California-based MemoryMD has received FDA clearance for NeuroEEG, a wireless amplifier that transmits EEG signals to computers and cloud-based databases via Bluetooth. The other half of MemoryMD's offering, a disposable EEG cap called NeuroCap, is still awaiting clearance.
"Essentially we’ve innovated on existing EEG solutions in the market," MemoryMD Chief Quality...