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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
FDA Grants Vapotherm Oxygen Assist Module (OAM™) Breakthrough Device Designation
Vapotherm Oxygen Assist Module is a module for use with most versions of Vapotherm’s Precision Flow® systems.
OrthoSensor Receives 510(k) Alignment Clearance For VERASENSE™
OrthoSensor notes VERASENSE™ is to be used with Zimmer Biomet's Persona Knee System.
MBio is Seeking FDA Approval for LightDeck® Platform
MBio has been working with DARPA on a program, "Point-of-care Monitoring of the Host-Pathogen Interaction During Infection," since February 2018.
iTind Device Receives FDA de Novo Classification Order for Benign Prostatic Hyperplasia: A Non-Surgical Treatment Device
The iTind device was developed by the Israeli-based medical device manufacturer Medi-Tate.
US based NEXVOO Announces the Availability of Additional FDA and CE PPE
NEXVOO announced that it is assisting with the US and global pandemic by expanding its resources to offer additional PPE products into the US.
FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19
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.
BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S.A.
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.
FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic
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.