The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.
Sientra Inc., of Santa Barbara, Calif., reported gains in both its breast products and Miradry segments during its fourth-quarter earnings call after the close of the market March 11. For his part, CEO Jeff Nugent noted that the company had experienced record total net sales in the fourth quarter of $23.2 million, representing growth of 22% year-on-year. However, the company provided full-year 2020 guidance for 12% to 17% growth, which William Blair’s Margaret Kaczor said was below her organization’s 22% estimate, “though the shortfall is largely a result of negative impacts from COVID-19.”
Establishment Labs SA, from the Virgin Islands and with main manufacturing and marketing operations in Alajuela, Costa Rica, where it was founded, is entering the Japanese market with what it says is a revolutionary breast implant solution, starting this month.