Category: Scoop.it

After introducing its robot in multiple countries outside the U.S., including India, the company turns its focus to the world’s largest robotic surgery market.

Medivis has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its cranial navigation platform, making it the “world’s first” augmented reality (AR) system cleared for intraoperative guidance in cranial neurosurgery, according to the company.

The FDA’s change of heart has HeartBeam planning a commercial launch in the new year for its credit card-sized ECG system.

The FDA previously granted marketing authorization for CMR’s first-generation Versius Surgical System in October 2024.

The FL-100 tDCS system is available by prescription for adults with moderate to severe MDD in the current episode, either as monotherapy or as an adjunctive treatment.

/PRNewswire/ — Withings, the world leader in connected health, today announced that the FDA has cleared BeamO1, the revolutionary health check-up tool. This…

The Resona A20 device reportedly provides advances in imaging and AI automation along with an intuitive ergonomic design for ease of use.

The Austin-based startup will test its high-bandwidth device to help restore speech in people with extremely limited movement.

Augmedics announced today that it received FDA 510(k) clearance for X2, its next-generation augmented reality (AR) headset.

The company also posted weaker third-quarter results, but CEO David Fischel said orders for the new GenesisX system, when fully launched, would outpace the rate for an older model.