A new battle is emerging in the fight for health equity, and it's centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter.
Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety. The clearance was.
Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission.
The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics.
The FDA recently released three draft guidance documents that aim to "modernize" the 510(k) premarket notification process. This process permits medical device manufacturers to market.