Business Wire

Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
Business Wire

MAIA Biotechnology Announces FDA Clearance of IND Application for THIO, a First-in-Class Telomere Targeting Agent for the Treatment of Non-Small Cell Lung Cancer

CHICAGO--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that the U.S. Food and Drug ...
Med Device Online

Duty Of Disclosure Considerations For Medical Device Patent Applicants With Parallel FDA Submissions

Understanding the crucial overlaps between FDA disclosures and patent law is important for medical device innovators seeking ...
Morningstar

AliveDx registers MosaiQ®, its Instrument for Multiplex Testing of Autoimmune Diseases, Allergies and Beyond, as a Class II Exempt Device with the U.S. Food and Drug ...

The MosaiQ solution is a next-generation IVD solution for autoimmune diseases, allergies and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex ...