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 ...
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 ...
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").
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 ...
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 / ...
Frontiers15h
Liquid biopsy and Circulating Tumor DNA Assays in the Management of Breast Cancer
Since the discovery of cell-free DNA (cfDNA) in 1948, shedded DNA fragments have been applied to technologies ranging from pre-natal genetic screening and ...
Nasdaq6d
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 ...
Becker's Spine Review5d
Smith+Nephew earns FDA nod for total hip planning software
Smith+Nephew earned FDA 510(k) clearance for its Coriograph pre-planning software and modeling services, according to a Dec. 19 news release.
CNN5d
Which foods are ‘healthy’? FDA has new requirements for food labels
Improving access to nutrition information is an important public health effort the FDA can undertake to help people build healthy eating patterns,” FDA Commissioner Dr. Robert Califf said in a ...
Nasdaq5d
IMUNON, Inc. Advances IMNN-001 for Ovarian Cancer with FDA Alignment on CMC Strategy Ahead of Phase 3 Trial
IMUNON announced FDA alignment on CMC strategy for IMNN-001 ... cancer and the competitive landscape for new treatments, the timeline for the upcoming Phase 3 trial may not be aggressive enough ...
The Times and Democrat6d
A timeline of the fatal shooting of UnitedHealthcare CEO Brian Thompson and search for his killer
NEW YORK (AP) — After days of searching through security footage, following up on a deluge of tips and even sending scuba divers to the bottom of a lake, police on Monday announced the arrest of ...