Approvals

FDA Clears Angiography Module For Spectralis Imaging Devices

The FDA cleared Spectralis’ optical coherence tomography angiography (OCTA) module for use with its new and existing diagnostic imaging devices.

OCTA is a non-invasive imaging technique that produces 3D visualization of perfused ocular vasculature.

The module allows physicians to gain better insights into ocular abnormalities.

Korea’s Hironic Laser Acne Device Approved

The FDA granted approval to Hironic’s AFit laser device used for treating acne.

The device, which has also earned CE Mark approval, includes a 1450 nm diode laser that penetrates into the skin’s dermal and subcutaneous layers, in addition to a bipolar radiofrequency and cryogen cooling device.

The laser can treat skin conditions such as acne and acne scars, and encourage rejuvenation of the skin.

Cepheid Fingerstick HCV Test Gains CE Mark

Cepheid received the CE Mark for its fingerstick test used for quantifying viral loads of the hepatitis C virus.

The test, the Xpert HCV VL Fingerstick, detects RNA levels of the virus from blood samples and can be used in near-patient settings.

It can detect a wide range of virus genotypes in approximately one hour, so diagnosis and the start of antiviral treatment could occur within a single clinical visit.

Inui Health’s Smartphone Device for Urine Testing Gains Approval

The FDA granted clearance for Inui Health’s smartphone system for urine testing that covers five common tests.

Inui Health, formerly known as Scanadu, says its platform includes tests for UTIs, diabetes or pre-gestational diabetes, kidney issues and pre-eclampsia.

The device allows users to instantly see their test results, rather than having to send them to a provider for analysis.

FDA Clears b-One Ortho Total Hip System

The FDA granted b-One Ortho 510(k) marketing clearance for its total hip system, used in hip replacement surgery.

The cementless device uses advanced coating technology and consists of a bone-conserving femoral prosthesis and a primary acetabular system, compatible with b-One’s 12/14 taper femoral heads.

The company said the system will have a limited U.S. launch in the first half of 2019, followed by a full commercial release later in the year.

Heidelberg’s Angiography Module Approved

The FDA cleared Heidelberg’s optical coherence tomography angiography module, an imaging technique that gives a 3D analysis of perfused ocular vasculature.

The technology allows physicians to gain a better understanding of ocular abnormalities by using light waves to take cross-section pictures of the retina.

The device enables physicians to map and measure the thickness of the retina’s layers.

FDA OK’s Surgical Fluorescence for Vascular Neurosurgery

The FDA granted clearance to Leica Microsystems’ Glow800 product, an augmented reality surgical fluorescence that allows surgeons to observe the cerebral anatomy in natural color.

The solution improves a surgeon’s spatial orientation and the visual crispness of vessels as they perform vascular neurosurgery.

Leica Microsystems said the augmented reality fluorescence is the first of multiple imaging features it plans to release for its Glow platform.

Boston Scientific’s Drug-Eluting Stent Receives FDA Approval

The FDA approved Boston Scientific’s premarket approval application for its Eluvia drug-eluting vascular stent system.

The device is developed to treat peripheral artery disease by using a drug-polymer combination to continually release paclitaxel over one year.

It is designed to stop tissue from regrowing that may become an obstruction for the stented artery.

OrthoXel’s Femoral Nailing System Gains FDA Clearance

The FDA granted OrthoXel 510(k) clearance for its Apex femoral nailing system, a fracture fixation device for the femur.

The system gives physicians numerous locking options, such as the patented OrthoXel micromotion for controlled axial movement, which offers torsional stability to encourage callus formation.

FDA Clears Two Oral Fluid Assays for Premier Biotech’s Drug Screener

The FDA granted Premier Biotech 510(k) clearance for two additional assays used with its OralTox oral fluid drug screening device.

The Minnesota-based company’s recently cleared assays are used to detect the presence of Oxycodone and Methadone in oral samples.