FDA clears a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in addition to cuffless...
Stakeholders give comments and suggestions to FDA on its draft guidance on using digital health technologies for remote data acquisition.
Two medical device stakeholders comment on an FDA draft guidance to transition devices into normal compliance when the Covid-19 public health emergenc...
FDA approves a 2 mg dosage level of Novo Nordisks diabetes drug Ozempic.
FDA approves a Staar Surgical PMA for the EVO/EVO+ Visian Implantable Collamer Lens for correcting myopia and myopia with astigmatism.
An FDA advisory committee briefing document released in advance of a 3/30 panel meeting shows the agency is skeptical of the data contained in Amylyx ...
Federal Register final rule: FDA amends the medical device regulations to update mailing address information and to reduce the number of copies of cer...
Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbrev...