Becton, Dickinson and Company (BD) has received the US Food and Drug Administration’s (FDA) 510(k) clearance for the Phasix ...

LEM Surgical’s Dynamis robot for spine surgery earned FDA 510(k) clearance, according to an April 24 news release. The robot is the first multi-arm system for hard tissue surgery. One arm is for ...

The Layer 7 Cortical Interface is a high-resolution cortical electrode array for use in recording, monitoring, and ...

By Karen Roman Nano-X Imaging Ltd. (Nasdaq: NNOX) said its multi-source digital imaging system, Nanox.ARC X, received FDA 510 ...

LEM Surgical announced that it received FDA 510(k) clearance for its Dynamis robotic surgical system for hard tissue surgery.

Medtronic (MDT) has submitted 510(k) applications to the FDA seeking clearance for an interoperable pump. FDA clearance of this pump would pave ...

Medtronic has submitted 510(k) applications to the U.S. Food and Drug Administration seeking clearance for an interoperable pump.

Ark Surgical, a women's health-focused medical device innovator, has received FDA 510(k) clearance for LapBox® POWER, a ...

LEM Surgical receives US FDA 510(k) clearance for its Dynamis Robotic Surgical System: Bern, Switzerland Saturday, April 26, 2025, 11:00 Hrs [IST] Bern-headquartered LEM Surgical, ...

NeuroOne (Nasdaq:NMTC) announced today that it filed an FDA 510(k) submission for its trigeminal nerve ablation technology.

Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy.