Approvals

FDA Clears TechLab’s Gastrointestinal Diagnostic Tests

The FDA granted 510(k) clearance for two TechLab gastrointestinal disease diagnostic tests, the H. pylori Chek and QuikChek tests.

Both tests are designed to help in the diagnosis of Helicobacter pylori infection, a bacterial infection linked to peptic ulcers.

The QuikChek test can diagnose infection in 30 minutes, while the Chek test is a 96-well plate format diagnostic used in laboratories for diagnosing large numbers of specimens in an hour.

UVision360’s Hysteroscopy System Receives 510(k) Clearance

UVision360’s Luminelle DTx system, a hysteroscopy device, received 510(k) clearance by the FDA for use in hysteroscopy and cystoscopy procedures.

The device allows physicians to examine the internal lining of the uterus and identify suspicious tissue, in addition to allowing biopsies under visualization.

The system is similar to operating room equipment but can be used by physicians to perform the procedures in their offices.

Gore Gets 510(k) Clearance of Molding and Occlusion Balloon

The FDA cleared Gore’s molding and occlusion balloon device, a compliant polyurethane balloon catheter.

The device meets all endovascular aortic repair procedural requirements, from 10 to 37 mm device sizes, and consists of a single balloon, removing the need for multiple molding and occlusion balloons.

It comes in a single catheter length of 90 mm for use with Gore Excluder devices and is designed to help clinicians with the expansion of self-expanding stent grafts and the temporary occlusion of large-diameter vessels. It is also compatible with 108 cm length guidewire.

FDA Clears Gynesonics’ Sonata System for Treating Uterine Fibroids

The FDA granted 510(k) approval for Gynesonics’ Sonata system, a sonography-guided transcervical fibroid ablation device.

The device uses intrauterine ultrasound technology with a radiofrequency ablation device to treat uterine fibroids.

The Sonata system provides women with a transcervical treatment for uterine fibroids that requires no incisions.

Philips’ Ultrasound Systems Cleared by FDA

Two of Philips’ cardiovascular ultrasound devices have gained 510(k) clearance from the FDA for performing diagnostic, pediatric and interventional echocardiography.

The Epiq CVx device helps clinicians in their inspections of the heart by offering improved image quality, while the Epiq CVxi offers a tool to improve communications between interventional cardiologists and echocardiographers.

The Epiq CVxi combines live ultrasound and X-rays into a single view.

Dthera’s Digital Alzheimer’s Treatment Granted Breakthrough Designation

The FDA granted Dthera Sciences breakthrough designation for its digital Alzheimer’s treatment, one of the first digital therapeutic products to receive the designation.

The digital device uses a custom-built tablet, equipped with a camera, to display memories relevant to the patient, such as photos of loved ones.

Artificial intelligence built into the device gauges the patient’s reaction to the displayed memories and adjusts content on the screen to guide the patient’s emotions.

FDA Clears Ceterix’s Suture Cartridge

The FDA granted 510(k) clearance for an additional feature of Ceterix Orthopaedics’ NovoStitch Pro Meniscal Repair System, a device used in repairing meniscal tears.

The device is used to place stitches arthroscopically within tight joint areas and allows surgeons to work on meniscal tears that previously responded poorly to repairs.

The cleared feature, a size zero suture cartridge, gives surgeons expanded options in suture size and enables them to pass a complete stitch in the knee joint without having to remove the device to reload a suture.

iVWatch Gains CE Mark for IV Surveillance Device

iVWatch received the CE Mark for its iVWatch Model 400, a continuous monitoring device for detecting intravenous infiltrations and the leakage of fluids.

The device, which has been cleared by the FDA, provides a measure of security for standard, unmonitored peripheral IVs.

It enables early detection of fluid leaks and notifications of infiltration, improving patient outcomes during IV therapy by identifying potential complications.