Ann: US FDA 510(k) Clearance for Bilateral Lymphoedema Assessment, page-2

Yay! .. read this article the other day ... now that we've had 3 in under 12 months I think we'd fall into this category?

The road to FDA clearance for medical devices may change radically in the next year.
Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process.

http://www.mobihealthnews.com/conte...orkshops-give-industry-and-agency-chance-talk

“This, our third 510(k) clearance in under 12 months for the SOZO® platform, follows our recent clearance for monitoring fluid levels in heart failure patients, achieving yet another important regulatory milestone in our journey of providing a new and improved model of care, across the patient care continuum.”