Clearances

FDA Clears Single-Use Articulating Laparoscope for Minimally Invasive Surgery

The 5mm Saberscope features a 90-degree articulating tip and integrated camera designed to reduce fogging and eliminate reprocessing needs.

The system integrates depth imaging technology directly into biopsy tools to improve tissue sampling accuracy during bronchoscopy.

New FDA clearances authorize the use of an AI tool to detect lung nodules and help triage pneumothorax and pleural effusion on chest X-rays.

The 5mm Saberscope features a 90-degree articulating tip and integrated camera designed to reduce fogging and eliminate reprocessing needs.

Nov 12, 2024

Philips’ Spectral CT 7500 RT, now FDA-cleared, integrates spectral CT into radiotherapy, enhancing tumor visualization and targeting.

Nov 7, 2024

Zeta Surgical’s Zeta Navigation System has received FDA clearance for expanded instruments and enhanced hospital connectivity.

Oct 28, 2024

Paragonix Technologies received FDA 510(k) clearance for KidneyVault, a portable kidney preservation device with digital monitoring.

Oct 24, 2024

Epitel’s REMI Vigilenz AI For Bedside Notifications has received FDA 510(k) clearance, notifying clinicians of potential seizures.

Oct 16, 2024

The FDA approved marketing for CMR Surgical’s Versius Surgical System, designed to assist in minimally invasive soft tissue surgeries.

Oct 11, 2024

Natus Medical submitted an FDA 510(k) notification for its point-of-care EEG device, designed to identify seizures in acute care settings.

SamanTree Medical's Histolog Scanner has received FDA 510(k) clearance for imaging the internal microstructure of tissues, such as cells and vessels.