Avita Medical announces FDA 510 clearance for Cohealyx
AVITA Medical (RCEL) “announced that the FDA has granted 510(k) clearance for Cohealyx, a new collagen-based dermal matrix branded by AVITA ...
Becker's Spine Review10d
30 spine devices granted 510(k) clearance in 2024
30. Providence Medical Technology earned FDA clearance for its Cavux FFS-LX lumbar facet fixation system. It is an integrated cage and screw system that's implanted bilaterally in the facet joints for ...
AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market
New collagen-based dermal matrix designed for tissue generation, complementary to RECELL and PermeaDermCohealyx expected to triple AVITA ...
The Sun News6d
Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting with FDA
"This meeting reaffirmed our strategic decision to effectuate a multigenerational product strategy and submit the mBôs TKA System for FDA clearance on an accelerated timeline," said Ben Sexson ...
Hosted on MSN6d
HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance
Distinguished by its credit card size and cable-free design, the device is claimed to be the first of its kind to be cleared ...
GlobalData on MSN8d
Zimmer Biomet’s total shoulder replacement system gains FDA 510(k) clearance
Zimmer Biomet has gained 510(k) clearance from the US Food and Drug Administration (FDA) for the OsseoFit Stemless Shoulder ...
Nasdaq5d
Intelligent Bio Solutions Inc. Submits FDA 510(k) Application for Intelligent Fingerprinting Drug Screening System
Intelligent Bio Solutions Inc. (INBS) has submitted a 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System, a rapid and non-invasive drug testing ...
Charlotte Observer6d
Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting with FDA
meeting with the U.S. Food and Drug Administration ("FDA") on December 17, 2024, regarding its 510(k) premarket filing submission for the Company's mBôs TKA System (the "Application").
Monogram Technologies Inc.: Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting with FDA
Management Anticipates That it has Sufficiently Addressed the FDA's Concerns to Mitigate the Need for a Clinical Data RequestManagement Anticipates a Comprehensive AIR Response in Q1 2025 AUSTIN, TX / ...