The US Food and Drug Administration (FDA) has granted 510(k) approval to Synergetics' VersaVIT vitrectomy system for use during performing retinal surgeries. Synergetics president and CEO David Hable said, "We believe that VersaVIT is ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Teleflex Incorporated's ArrowADVANTAGE5 non-coated pressure-injectable peripherally inserted central catheter (PICC) for central venous pressure (CVP) monitoring ...
Tags: pressure-injectable, central venous pressure, CVP, central catheter
OptiMedica has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Catalys Precision Laser system, designed for creating single-plane and multi-plane arc cuts/incisions in the cornea during performing ...
Tags: OptiMedica, US Drug Administration, Catalys Precision Laser system
William Beaumont Hospital, a three-hospital regional health system, has purchased BSD Medical's MicroThermX Microwave Ablation system. The MicroThermX system, which features a microwave generator, single-patient-use disposable antennas, ...
MedShape has launched an intramedullary (IM) nail device, designed for use in ankle arthrodesis procedures. Harnessing the shape memory properties of internal nickel titanium (NiTiNOL) element, the DynaNail device sustains compression ...
Tags: intramedullary nail device, shape memory, ankle arthrodesis
The US Food and Drug Administration (FDA) has granted 510(k) approval to Olea Medical's Olea Sphere medical imaging enterprise software. Olea Sphere provides display, analysis and post-processing functionality for viewing perfusion ...
Tags: medical imaging enterprise software, imaging enterprise software
The US Food and Drug Administration (FDA) has granted 510(k) approval to Medigus's SRS endoscopic system. The approval was based on a multi-center clinical trial which met a criteria of safety and efficacy in five countries and three ...
Tags: SRS endoscopic system, endoscopic system, SRS endoscope, the SRS system