Lantheus Holdings, Becton Dickinson are among manufacturers to say in recent financial reports that the hurricane has ongoing impacts for the companies.
While Hurricane Maria hit Puerto Rico six weeks ago, its full financial impact is yet to be felt by some device manufacturers, according to quarterly earnings reports from companies over the past week.
For example, medical imaging agent company Lantheus Holdings Inc. isn’t sure when, or if, it will fully recover. In...
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
