FDA clearance pending for Base Ten's Prenval 1
This article was originally published in Clinica
Base Ten Systems (US) says it has been informally advised that the FDA will clear its Prenval 1 foetal abnormality software program as a Class 1 Tier 3 medical device under the 510(k) process. The Trenton (NJ)-based company expects to meet FDA officials by mid-July to complete the labelling details prior to formal clearance, allowing it to introduce the program by mid-September. The software was considered by the FDA's advisory panel earlier this year (see Clinica No 649, p 7).