Product Approval Summaries
DEVICES
FDA has cleared a Fiagon 510(k) for its brain navigation software, BiopsyPointer FlexPointer 1.5 and the ShuntPointer. The device uses an electromagnetic tracking system to locate surgical instruments during a surgery in relation to a patient’s CT scan. It relies on instruments that have a proprietary “chip on the tip” technology, including bendable instrumentation to reach challenging anatomy.
Hologic has received 510(k) from FDA for the Affirm prone biopsy system that offers both 2D and 3D imaging-guided breast biopsies. The device provides a larger field of view than current systems, which allows radiologists to better target lesions found during 3D mammography exams, as well as other screening modalities, according to the company. “With the patient lying prone, the biopsy system provides true 360-degree access to lesions using a fully integrated C-Arm,” it says. “Approach angles can be varied with minimal movement on the patient’s part, as the patient is supported stably throughout the procedure.”
FDA has cleared an Oculus Innovative Sciences 510(k) for the Microcyn-based Lasercyn Gel, intended for use for managing post-non-ablative laser therapy procedures, post-microdermabrasion therapy and following superficial chemical peels. Lasercyn may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns, according to the company. “In our clinical testing of Lasercyn to date, we have seen dramatically improved outcomes with quicker healing times and less patient discomfort when Lasercyn is added to the post-procedure management protocol,” it says.
Toshiba America Medical Systems has received FDA 510(k) clearance for its Aquilion Lightning CT system. The 16-detector row system is designed for routine volumetric scanning. It has a small footprint to allow providers to save on both space and cost, according to the company. It offers the company’s [PURE] ViSION CT Detector technology that is used in premium Toshiba CT systems and includes AIDR 3D Enhanced to help reduce dose and improve patient safety, the company says. “To simplify complex scans for more consistent imaging, the system comes standard with Adaptive Diagnostic solutions, such as Single Energy Metal Artifact Reduction (SEMAR) and [SURE] Subtraction, Toshiba notes. “These technologies, along with the industry’s thinnest slices, at 0.5 mm, and a 78-cm bore that is the widest in the 16-row detector radiology segment, help optimize workflow and patient comfort.”
HUMAN DRUGS
AbbVie says FDA has approved a supplemental NDA for the use of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin in patients with genotype 1b chronic hepatitis C virus infection and compensated cirrhosis.
FDA has approved an Avedro NDA for its Photrexa Viscous, Photrexa and the KXL System for corneal collagen cross-linking for treating progressive keratoconus. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking. Keratoconus is a progressive thinning and distortion of the cornea. It causes the cornea to bulge from its normal symmetric domelike smooth optical shape, creating an abnormal curvature that changes the cornea’s optics, producing blurred and distorted vision that is difficult to correct with spectacle lenses. This can result in significant visual loss and may lead to corneal transplants.