Approvals

Cepheid’s Hepatitis B Viral Load Test Gains CE Mark

Cepheid received the CE Mark for a rapid molecular assay, the Xpert HBV Viral Load Test, which measures viral loads of Hepatitis B in patients.

Using Cepheid’s GeneXpert system, the test measures a patient’s HBV DNA levels via plasma or serum samples and produces quantitative results in less than an hour.

The test can be used for predicting the likely development of a disease and to measure a patient’s response to antiviral treatment.

FDA Clears Becton Dickinson’s Enteric Viral Panel

The FDA granted Becton Dickinson 510(k) clearance for its molecular diagnostic test, the BD MAX enteric viral panel.

The test detects enteric viral pathogens that cause viral gastroenteritis and can distinguish between them.

The BD MAX can perform targeted detection for norovirus, rotavirus, adenovirus, human astrovirus and sapovirus.

The enteric panels run on the BD MAX molecular system and can provide results in less than 3.5 hours.

CathWorks’ Fractional Flow Reserve System Cleared

The FDA cleared CathWorks’ non-invasive FFRangio fractional flow reserve system for measuring blood pressure and flow through the coronary artery.

Fractional flow reserve is used during coronary catheterization to determine the likelihood that an abnormal narrowing of a blood vessel will hinder oxygen delivery to the patient’s heart.

The device is used during coronary angiography procedures to help physicians make clinical decisions without the need for another intervention.

Quidel Gains CE Mark for Vitamin D Assay

Quidel has earned the CE Mark for its point-of-care Sofia Quantitative Vitamin D Assay for use with its Sofia fluorescent immunoassay analyzer.

The assay analyzes serum samples to determine the total amount of vitamin D in the patient’s body.

Vitamin D deficiency has been linked to various health issues including cancer, cardiovascular diseases, bone disease and hypertension.

European Commission Approves AstraZeneca’s COPD Treatment

The European Commission has approved AstraZeneca’s Bevespi Aerosphere, a long-term chronic obstructive pulmonary disease (COPD) treatment that is administered via a pressurized metered-dose inhaler.

The twice daily, fixed-dose device combines glycopyrronium and formoterol fumarate.

The treatment is not indicated for the relief of acute bronchospasm or for treating asthma.

Hycor Biomed Cleared in U.S. for Allergy Testing System

The FDA granted clearance for Hycor Biomedical’s Noveos allergy testing system for use in allergy testing labs.

The device can handle up to 700 tests in one run. The system allows a significant reduction in sample sizes, blood-based interferences and allergen lot variabilities.

FDA Grants PMA for Cardiva’s Vascular Closure Device

Cardiva Medical has received FDA premarket approval for its Vascade MVP venous vascular closure device, for stopping patient bleeding following electrophysiology procedures.

The device is made up of a bioabsorbable collagen patch and a collapsible mesh disc. The disc is used to temporarily stop bleeding from a vessel, after which the patch is inserted and serves as a seal.

FDA Clears Hemodynamic Monitoring Device

The FDA granted 510(k) clearance to Retia Medical’s Argos hemodynamic monitor that measures an adult patient’s cardiac output in the operating room and ICUs.

The device uses signal processing and algorithms to create a model of the patient’s circulation, giving physicians information that helps them track oxygen delivery and fluid status in high-risk surgeries.

Human Milk Analyzer Cleared for Marketing

The FDA cleared the Miris Human Milk Analyzer, a diagnostic test that measures the amount of nutrients in breast milk, for marketing.

The device determines the concentration of carbohydrates, fat, protein, total solids and energy.

The analyzer is intended to help parents and healthcare providers meet the nutritional needs of infants, especially those who require additional nutrients because of health conditions or preterm birth.

Japan Approves Coronary Orbital Atherectomy Device

Japan’s Ministry of Health, Labor and Welfare approved Cardiovascular Systems’ Diamondback 360, a coronary orbital system for removing sclerosis from blood vessels. The device facilitates stent delivery in coronary artery disease patients who are eligible to receive stenting or coronary angioplasties.