Approvals

MolecuLight Gains FDA’s De Novo Clearance for Fluorescent Imaging Device

Toronto, Ontario-based devicemaker MolecuLight received the FDA’s De Novo clearance for its handheld fluorescence imaging device, the MolecuLight i:X.

The portable device captures fluorescence information from wounds and surrounding tissue using still images and videos in real-time.

The device, which previously received the CE Mark and Health Canada Medical Device License, allows clinicians working on skin wounds to digitally record images of the wound and images of fluorescence emitted from the wound when exposed to an excitation light

FDA Approves Ivantis’ Hydrus Microstent

The FDA gave its approval for California devicemaker Ivantis’ Hydrus microstent, used for treating patients with mild to moderate primary open-angle glaucoma (POAG).

The microstent is roughly the size of an eyelash and is made from a super-elastic, biocompatible alloy that is used in many implants.

It is designed to relieve high intraocular pressure frequently seen in patients with POAG by allowing blocked eye fluid channels to flow freely.

Implantica Receives CE Mark for RefluxStop

Medical technology company Implantica earned a CE Mark for its RefluxStop device, used for treating patients that suffer from acid reflux.

Implantica received the CE Mark based on results from a multi-center investigation that demonstrated its safety and effectiveness, and it may now market the device in the European Economic Area and Switzerland.

The device avoids potential complications that arise from compressing the food passageway — such as difficulty swallowing and inability to burp or vomit — treating gastroesophageal reflux disease without squeezing the passageway.

CoreLink’s 3D Anterior Lumbar Approved by FDA

CoreLink received FDA approval for its 3D anterior lumbar interbody device, a spinal implant that mimics the characteristics of natural bone.

The device has a load-sharing support structure and an interconnected lattice to provide strength, stability and stiffness.

The structure of the implant also allows for better imaging by minimizing material density.

FDA Allows Marketing of Brainsway’s TMS for OCD Treatment

The FDA has permitted marketing of Brainsway’s deep transcranial magnetic stimulation (TMS) device for treating obsessive compulsive disorder.

“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” said Carlos Peña, director of CDER’s Division of Neurological and Physical Medicine Devices. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”

The agency said the device should not be used by patients with metallic objects or implants that are in or near the head, such as cochlear implants, aneurysm clips or coils or deep brain stimulators.

TPlus Receives CE Mark for Medical Image Archiver

Korean device manufacturer TPlus received European certification for its View Vine picture archiver and communication system.

The picture archiving and communication system sends, stores and receives medical images and supports real-time image recognition.

The device has been stripped of less frequently used functions and now generates only integral images used to show the average intensity of pixels, to assist in diagnosis.

Kleresca Approved in EU for Dermatological Platform

Dermatological device developer Kleresca gained a CE Mark for its biophotonic dermatological system.

The device uses a non-invasive fluorescent light treatment to encourage the skin’s biological processes, repair skin in patients and treat rosacea. It can also be used as an add-on treatment for other dermatological procedures, such as laser treatments.

The device cannot cause a photosensitive reaction because the treatment gel is not absorbed by the skin, and the treatment does not damage the skin’s natural barriers.

FDA Clears SPR’s Nerve Stimulator for Pain Relief

SPR Therapeutics’ received FDA clearance for its single and dual lead peripheral nerve stimulator.

The devices are minimally invasive alternatives to opioids that are implanted for up to 60 days to relieve acute and chronic pain, including post-traumatic and post-operative pain. The components are removed after treatment.

The nerve stimulator comes with a wearable electronic pulse generator that has rechargeable batteries and a Bluetooth compatible remote.