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Tag: 510(k)

Similarities and Differences between Medical Device 510(k) and CE Marking

Medical Devices
This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects...

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FDA and Health Canada streamline medical device submissions with joint eSTAR portal

Medical Devices
The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot.The joint...

Selux Diagnostics secures FDA 510(k) clearance for AST testing NGP System

Medical Devices
<!----> The US Food and Drug Administration (FDA) has granted 510(k) clearance to Boston-based biotech startup SeLux Diagnostics’s...

Four easy ways 510k and De Novo content is different

Medical Devices
Posted by Rob Packard on January 17, 2023 It’s a common misconception that FDA De Novo content is very different from FDA...

Viz.ai launches Viz Vascular Suite to detect vascular disease

Medical Devices
<!----> Provider of artificial intelligence (AI)-powered disease detection and intelligent care coordination Viz.ai has rolled out its Viz...

Asensus Surgical Provides Preliminary 2022 Year-End Corporate Update

Medical Devices
RESEARCH TRIANGLE PARK, N.C., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the...

Pristine Surgical’s Summit arthroscope secures FDA 510(k) clearance

Medical Devices
<!----> Medical technology manufacturer Pristine Surgical has secured 510(k) clearance for its Summit 4K single-use surgical arthroscope from...

Vivos’ DNA oral appliance gets FDA 510(k) clearance to treat OSA

Medical Devices
<!----> Vivos Therapeutics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its DNA...

Pristine Surgical Receives FDA 510(k) Clearance for Summit™, the World’s First 4K Single-Use Surgical Arthroscope

Medical Devices
Designed to Improve Procedure Efficiency, Consistency, and Safety MANCHESTER, N.H.--(BUSINESS WIRE)-- Medical device company Pristine Surgical received 510(k) clearance from the U.S. Food and Drug...

ABM Respiratory Care’s BiWaze Clear System receives FDA 510(k) clearance

Medical Devices
<!----> Medical technology firm ABM Respiratory Care has received 510(k) clearance for its BiWaze Clear System from the...

ABM Respiratory Care Announces the FDA Clearance of the BiWaze Clear System

Medical Devices
EAGAN, Minn., Dec. 29, 2022 /PRNewswire/ -- ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance...

FDA Approves Polarean’s XENOVIEW™ (xenon Xe 129 hyperpolarized) for use with MRI for the Evaluation of Lung Ventilation

Medical Devices
XENOVIEW represents the first and only hyperpolarized MRI contrast agent ● FDA approved indication includes both adolescents and adults representing a significant market opportunity...

EOFlow seeks FDA approval for wearable disposable insulin pump

Medical Devices
<!----> EOFlow is seeking approval from the US Food and Drug Administration (FDA) for its wearable disposable insulin...
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