Approvals

United Health Products Granted CE Mark for Hemostatic Gauze

United Health Products received a CE Mark for its product, HemoStyp, in the European Economic Area, for internal surgical procedures.

HemoStyp is a patented, hemostatic gauze intended for use in the healthcare and wound care sectors. It is effective in immediate homeostasis, accelerating healing for trauma and post operational wounds and defending the wound site.

The product is created with regenerated oxidized cellulose and designed to control bleeding and absorb exudate and drainage from superficial wounds.

Exactec Cleared to Market Equinoxe Shoulder Prosthesis Product

The FDA issued Exactec 501(k) clearance for its Equinoxe stemless shoulder prosthesis.

The device incorporates a bone cage for bone through-growth to increase the chances of biological fixation and uses a three-dimensional porous structure.

The product is designed for anatomic total shoulder arthroplasty.

CereMetrix’s Brain Imaging Device Receives 510(k) Clearance

CereMetrix received 510(k) clearance from the FDA for its neuroimaging analytics and quantification platform, CereMetrix Silver, an image viewer for brain imaging analysis that can detect, quantify and evaluate brain function.

The device, which serves as a tool to aid in the evaluation and information management of digital medical images, can analyze PET, SPECT, MRI and CT scans.

Accuray’s Data Management System Upgrade Gets 510(k) Clearance

Accuray’s iDMS data management system, which was upgraded for use with the company’s TomoTherapy platform, received 510(k) clearance from the FDA.

The system is designed to integrate with different systems, including TomoTherapy, Radixact, Accuray Precision and CyberKnife, as well as third-party treatment planning and oncology information systems.

Qiagen’s T. vaginalis Detection Kit Gains CE Mark

Qiagen’s new artus assay for detection of the sexually transmitted infection Trichomonas vaginalis received a CE Mark.

The kit detects the infection from DNA collected from vaginal swabs, endocervical swabs and urine samples. The diagnostic test is designed for use with the company’s QIAsymphony SP/AS and Rotor-Gene Q instruments.

T. vaginalis is the most common curable STI and it can cause adverse pregnancy outcomes, infertility and postoperative infections.

Philips Gets Go Ahead to Market ProxiDiagnost N90

The FDA issued a 510(k) clearance for Philips’ ProxiDiagnost N90, a digital radiography and nearby fluoroscopy system.

The dual-use device provides low-dose, high quality images, eliminating the need for several frames to produce a useable image for diagnosis. It also features an open overhead area and table which allows closer proximity to the patient during procedures.

The device is able to perform both nearby fluoroscopy and digital X-rays.

UroViu’s Uro-V System Gets 510(k) Clearance

The FDA granted 510(k) clearance to UroViu’s Uro-V system, a single-use, handheld diagnostic cystoscope designed for female diagnostic cystoscopy.

The battery-operated device uses a disposable cannula with a reusable handle that includes a video processor, touch panel interface and LCD display. The tube is equipped with a 140-degree-field-of-view camera and an LED illumination module and a shared single channel for fluid infusion.

Trice Medical Earns CE Mark and Health Canada Approval for mi-eye 2

Trice Medical received a CE Mark and Health Canada approval for its mi-eye 2, a camera-equipped throwaway needle intended to help diagnose joint injuries.

The updated device includes enhanced resolution, field of view and depth of field. The product is designed for diagnostic and operative arthroscopic and endoscopic procedures to provide visualization of interior cavities of the body through natural or surgical openings. It also allows physicians to inject or aspirate under direct visualization.