Approvals

ZOLL Wins FDA Nod for Full Line of Defibrillators

ZOLL Medical received premarket approval from the FDA for its entire line of defibrillators, including the R Series and X Series monitor/defibrillators, as well as the AED Pro and AED Plus automated external defibrillators.

All of the devices feature the company’s Rectilinear Biphasic waveform and Real CPR Help technology.

OrthoXel Apex Tibial Nailing System Achieves FDA Clearance and CE Mark

Orthopedic trauma devicemaker OrthoXel, achieved both FDA 510(k) clearance and a CE Mark for its Apex Tibial Nailing system.

The system has multiple locking modes, including the standard cross-locking and dynamization locking, to enable surgeons to tailor the fixation to patients’ individual health needs.

The device “offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure,” the company said.

FDA Clears First-of-its-Kind Robotic Imaging System

Massachusetts devicemaker Medrobotics achieved 510(k) clearance for its Flex Robotic System.

The system includes two working channels to accept a wide variety of surgical and interventional instruments. It is the “world’s first and only” flexible transabdominal and transthoracic robotic scope, the company said.

The system provides robot-assisted visual imagining during general, gynecological and thoracic surgical procedures, enabling minimally invasive treatments.

Viz.ai Gets CE Mark for Artificial Intelligence-Powered Stroke Care System

Viz.ai, a San Francisco-based developer of artificial intelligence imaging and workflow software, obtained a CE Mark for its ContaCT.

The device conducts automatic analyses of brain CT scans using deep learning algorithms, and sends notifications to specialists of large vessel occlusions.

Early intervention is critical in stroke treatment, and ContaCT is the first AI-based “direct-to-intervention” system, the company said.

International Biophysics’ Disposable Heart Pump Achieves FDA Clearance

The FDA cleared the FloPump 32 centrifugal disposable heart pump manufactured by International Biophysics.

The single use pump is intended for use with the company’s Maquet RotaFlow console.

The product received a CE Mark in Europe and ANVISA clearance in Brazil last year.

Honda Snags CE Mark for Walking Assist Device

Tokyo-based Honda Motor received a CE Mark for its Honda Walking Assist Device.

The device is intended to use for walking training and rehabilitation.

The company worked with the Japan-based third-party ISO certification organization, Japan Quality Assurance Organization, and the German-based third-party certification organization, TÜV Nord Cert, to obtain the CE Mark.

FDA Clears Centric Medical Cannulated Screw System

The FDA issued 510(k) clearance to Life Spine’s Centric Medical division for its Cannulated Screw Internal Fixation System.

The multi-component, titanium alloy system is intended for use in foot and ankle reconstruction procedures. It provides a variety of diameters and lengths with head and headless designs,

Entegrion Gets CE Mark for Portable Blood Coagulation Monitoring System

Entegrion received CE Marking for its portable blood coagulation monitoring system.

The system is indicated for use in clinical settings to obtain viscoelastic measurements of patients’ whole blood coagulation and hemostasis.

It also “offers a near patient and fully automated whole blood result without the need for sample pre-treatment reagents or sample transfer to the clinical laboratory,” the company said. “Within minutes, a clotting result will begin to be displayed at the patient’s side.”

Hologic Wins FDA Nod for Hepatitis B Assay

Hologic received PMA approval for its Aptima HBV Quant Assay for measuring hepatitis B viral load on its automated Panther system.

The assay joins two other Hologic viral load assays for use on the Panther system — one for human immunodeficiency virus and one for hepatitis C virus.

They assays all use the company’s proprietary real-time transcription-mediated amplification technology and provide sample-to-result automation.

Mesa Biotech Snags CE Mark for ‘Palm-Sized’ Testing System

San Diego-based molecular diagnostic company Mesa Biotech received CE Marking for its Accula System.

The palm-sized, reusable dock with disposable test cassettes can provide test results in about 30 minutes using samples from nasal swabs.

Mesa Biotech plans on launch its Flu A/Flu B test first in the European market.

FDA Clears Diazyme Vitamin D Assay

The FDA cleared Diazyme Laboratories’ EZ Vitamin D assay for marketing.

The assay is for use on validated clinical chemistry analyzers and provides fully automated results.

It also “enables clinical laboratories of almost any size to run Vitamin D tests in house without the need for expensive specialized instrumentation,” said Chong Yuan, the company’s managing director.