510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has the same safety and effectiveness ...

Provides Efficient Interaction with Consolidated AI ResultsPALO ALTO, Calif., March 03, 2025 (GLOBE NEWSWIRE) -- Fovia Ai, ...

Earlier versions of Ventripoint's scanning technology received FDA, Health Canada and E.U. regulatory approvals and are being used by leading hospitals in the U.S., E.U., U.K. and Canada.

Shares of Ventripoint are surging on the news that the company had received U.S. Food and Drug Administration (“FDA”) 510(k ... and E.U. regulatory approvals and are being used by leading hospitals in ...

NEW YORK – Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use. The single ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like irregular heart rhythm or sleep apnea alerts. They are usually labeled as such.

Detailed price information for Firefly Neuroscience Inc (AIFF-Q) from The Globe and Mail including charting and trades.

On January 28, GE HealthCare Technologies Inc. (NASDAQ:GEHC) revealed that it had acquired FDA 510(k) approval for its revised Voluson Expert Series ultrasound systems which use sophisticated ...

OBAMED Inc. is proud to present the first light-weight, FDA 510(k) approved, compact, portable Anesthesia Machine specifically designed for surgical locations where space or access is limited ...

For this list, we scoured Insider Monkey’s database of 1008 elite hedge ... revealed that it had acquired FDA 510(k) approval for its revised Voluson Expert Series ultrasound systems which ...