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Tag: PMA

Xstim, Inc. Receives FDA Approval for Xstim™ Spine Fusion Stimulator. | BioSpace

IRVING, Texas, April 16, 2024 /PRNewswire/ -- Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce...

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Sequana Medical announces 2023 Full Year Results and 2024 Outlook | BioSpace

PRESS RELEASEREGULATED INFORMATION – INSIDE INFORMATION28 March 2024, 08:00 a.m. CET alfapump® – PMA1 submitted to US FDA and accepted for substantive review, extensive feedback...

US Approves AIM-9X Block II+ Foreign Military Sale To Italy

The sale was previously announced by NAVAIR in 2021, when the Italian Air Force signed the Letter of Offer & Acceptance. A month after the...

Ultrathin vdW Ferromagnet at Room Temperature (MIT)

A technical paper titled “Current-induced switching of a van der Waals ferromagnet at room temperature” was published by researchers at Massachusetts Institute of Technology...

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

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...

Spineart Completes Enrollment in the Baguera®C IDE Trial for Single-level Cervical Disc Replacement | BioSpace

GENEVA, Feb. 29, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its...

Integer Holdings Corporation Reports Results for Fourth Quarter and Full Year 2023 | BioSpace

Strong 4Q and Full Year sales and profit increase versus last year Expect 9% to 11% sales growth in 2024 with expanding margins PLANO, Texas, Feb....

Sequana Medical announces DSMB approval to start randomized MOJAVE cohort – US Phase 1/2a study of DSR® 2.0 for treatment of heart failure |...

PRESS RELEASEREGULATED INFORMATION – INSIDE INFORMATION23 January 2024, 07:00 am CET DSMBi rates DSR 2.0 as safe following review of data from non-randomized cohort Data from...

Revolutionizing Air Combat: Lockheed Martin integrates advanced AARGM-ER missile into F-35 fleet, bolstering global defense capabilities – ACE (Aerospace Central Europe)

Lockheed Martin has embarked on a significant initiative to integrate the AGM-88G Advanced Anti-Radiation Guided Missile – Extended Range (AARGM-ER), developed by Northrop Grumman,...

Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis | BioSpace

REGULATED INFORMATION – INSIDE INFORMATION Pending FDA approval, alfapump could become the first active implantable medical device in the US for treating liver ascites Ghent,...

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