MassDevice3d
Johnson & Johnson wins FDA IDE for Ottava surgical robot
Johnson & Johnson MedTech announced today that the FDA granted its Ottava surgical robot investigational device exemption ...
MassDevice11d
R3 Vascular wins FDA IDE for drug-eluting scaffold
R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its drug-eluting ...
Hosted on MSN7mon
Concept wins another IDE from FDA for MagicTouch range
The US Food and Drug Administration (FDA) has granted Concept Medical an investigational device exemption (IDE) for its MagicTouch arteriovenous fistula (AVF) catheter, allowing the company to ...
pharmaphorum15d
Celgene investors’ CVR payment looks rocky, as FDA rejects ide-cel file
Ide-cel is intended to treat patients with heavily pre-treated relapsed and refractory multiple myeloma, AND was submitted to the FDA in March.
pharmaphorum14d
FDA’s review date for BMS’ ide-cel sneaks under the CVR wire
The FDA has given a 27 March 2021 review date for Bristol-Myers Squibb’s multiple myeloma cell therapy ide-cel, just in time to meet a contingent value right (CVR) due to Celgene shareholders if ...
Nasdaq22d
Adagio Medical Announces Completion of First Procedures in FULCRUM-VT U.S. FDA Pivotal IDE of Ventricular Tachycardia Cryoablation System
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc. (Nasdaq: ADGM; “Adagio Medical”, “Adagio” or the “Company”), a leading innovator in ...