The product can conduct electrocardiograms and measure the heart’s rhythms.
Innovators will also receive guidance in the areas of prototyping, engineering, IP, testing, grant-writing and clinical trial design.
The agency is aiming to provide more transparency and consistency in this area.
The Wall Street Journal reports that the scandal-ridden company will dissolve after failing to sell itself, and investors will lose nearly $1 billion.
Following protocols and maintaining compliance have been common themes.
The decision was made after analyzing data from a long-term safety study.
The Children’s National Health System is accepting proposals for technologies that address unmet needs in children.
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
The increase is significantly less than FY 2018, which saw user fees go up 33%.
The device will no longer be available after December 31, 2018.