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FDA grants clearance for Inogen’s SIMEOX 200 airway clearance device
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Inogen’s SIMEOX 200 Airway Clearance Device for ...
JD Supra4h
FDA Sued Over Laboratory Developed Tests Final Rule
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
Inogen Gets FDA Clearance for Airway Clearance Device
Inogen said regulators have cleared its SIMEOX 200 Airway Clearance Device to be used by U.S. patients with chronic respiratory diseases. The medical technology company said Monday that the Food and ...
medtechdive11d
BD receives FDA warning letter over quality system violations
Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety ...
JD Supra1d
FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
Niagara Gazette4d
UB expert part of FDA committee that looked at AI-enabled medical devices
The U.S. Food and Drug Administration says there are more than 900 artificial intelligence and machine learning-enabled ...
Pacbiztimes.com1d
Inogen’s newest respiratory device gains FDA clearance
Goleta-based Inogen, a medical technology specializing in the manufacturing of portable oxygen containers, announced Dec. 30 that it had received U.S. Food and Drug Administration clearance for the ...
Inogen Secures FDA 510(k) Clearance For SIMEOX 200 Airway Clearance Device
Monday announced that the company has received U.S. Food and Drug Administration 510(k) clearance for the SIMEOX ...
Medical Design and Outsourcing7d
Vision check with FDA CDRH Director Dr. Michelle Tarver
Dr. Michelle Tarver, a veteran leader at the FDA, is director of the Center for Devices and Radiological Health at a pivotal ...