Category: FDA

Regulatory approval was based on data from Intact Vascular’s Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical trial, notably the first study to enroll patients with advanced disease below-the-knee and 100% dissected vessels.

Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients.

Under the EUA, CytoSorbents Corporation can make CytoSorb available, through commercial sales, to all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure who have early acute lung injury or acute respiratory distress syndrome (ARDS), severe disease, or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure, as described in FDA's authorization.

The FDA issued an immediately in effect guidance that outlines a temporary policy to help expand the availability of portable cryogenic oxygen and nitrogen containers.

Vapotherm Oxygen Assist Module is a module for use with most versions of Vapotherm’s Precision Flow® systems.

OrthoSensor notes VERASENSE™ is to be used with Zimmer Biomet's Persona Knee System.

MBio has been working with DARPA on a program, "Point-of-care Monitoring of the Host-Pathogen Interaction During Infection," since February 2018.

The iTind device was developed by the Israeli-based medical device manufacturer Medi-Tate.

NEXVOO announced that it is assisting with the US and global pandemic by expanding its resources to offer additional PPE products into the US.