Category: FDA

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.

The U.S. Food and Drug Administration continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19. As part of the response to this pandemic, the agency is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood.

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for COVID-19 (coronavirus) on site and get results in under three hours.

As part of the FDA's ongoing commitment to fight the Coronavirus Disease 2019 pandemic, today the agency issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components. 

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