Approvals

FDA Clears Misonix Ultrasonic Surgical System

The FDA has handed Misonix 510(k) clearance for its Nexus ultrasonic surgical platform, which integrates multiple solutions for surgical applications into a single device.

The system combines all the features of the company’s ultrasonic tools—BoneScalpel, SonicOne and SonaStar—to enable bone, tumor and tissue removal capabilities. Nexus’ smart technology makes the platform easier to setup and use.

Nexus features a new digital algorithm that provides more control and efficiency, and increased power to improve tissue resection rates. Misonix will launch the platform on the U.S. market in July.

Ignite Orthopedics Radial Head Arthroplasty System Cleared

Ignite Orthopedics has received 510(k) clearance for its Radial Head Arthroplasty System, the firm’s first product to receive FDA clearance.

The company’s Radial Head Arthroplasty System is designed to treat patients with fractured or degenerative arthritis of the proximal radius. Radial head fractures account for approximately one-third of all elbow fractures.

The system allows a spacer to be placed when joint stability requires added height. A surgeon can insert the spacer without having to dislocate the radius, which can disrupt the surrounding soft tissue and slow down surgery.

Acandis Stent Retriever Device Receives CE Mark

Acandis has earned the CE Mark for its new stent retriever, the Aperio hybrid thrombectomy device, which is compatible with vessel diameters from 1.5 mm to 5.5 mm.

The retriever is used to restore arterial flow in patients diagnosed with ischemic stroke due to large intracranial vascular occlusion. It can be delivered through common 0.021” microcatheters.

Acandis said the retriever’s design, which features small closed cells and large open cells, provides good vessel wall alignment, improved device expansion and efficient clot retention.

FDA Clears Leica Biosystems Digital Pathology System

The FDA granted Leica Biosystems 510(k) clearance for its Aperio AT2 DX system, an automated scanning and viewing platform.

The high-throughput device automatically scans pathology slides, delivering whole images quickly. It also allows the user to view the slides through the device.

The platform will be coupled with clinical management software to serve as an integrated digital pathology workflow solution upon launch, the company said.

DiaSorin Molecular’s VZV Assay Cleared

DiaSorin Molecular has nabbed the FDA’s clearance for its Simplexa VZV Direct assay, a molecular diagnostic test used to detect the varicella-zoster virus (VZV).

The diagnostic—which is meant to be used alongside the company’s HSV 1 and 2 direct assay—is used with samples of cerebrospinal fluid to detect virus DNA, making it effective in the diagnosis of meningitis and encephalitis.

VZV causes varicella (chickenpox), a highly transmissible disease most commonly experienced in early childhood that can cause acute meningitis.

Israeli Devicemaker Gains De Novo Clearance for Mobile Migraine Treatment

Theranica earned De Novo clearance from the FDA for its Nerivio Migra product, a neuromodulation device designed to treat migraines.

The device is placed on the upper arm and emits electrical pulses that are controlled via smartphone. It is indicated for treating migraines with or without aura—a visual, sensory, motor or verbal disturbance—in adults who don’t have chronic migraine.

Clinical data showed that the product “can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs,” said Messoud Ashina, president-elect of the International Headache Society.

iThera Medical Earns CE Mark for Imaging System

Munich-based iThera Medical received the CE Mark for its multispectral optoacoustic tomography (MSOT) imaging system that allows radiation- and contrast-agent-free imaging of soft tissue.

The system combines laser excitation and ultrasound detection for the analysis of hemoglobin, lipids, collagen and other chromophores in tissue.

MSOT makes use of the photoacoustic effect in which absorbed light results in the emission of acoustic signals. By tuning the wavelength of the laser, it can identify compounds by their color.

MSOT allows the study of disease processes on a molecular level. Exploratory clinical trials have already been completed for inflammatory bowel disease, various soft tissue cancers, systemic sclerosis, muscular dystrophy, and cardiovascular diseases.