Filing of a 510(k) Pre-Marketing Notification Application with the FDA for Exogenesis Hernia Mesh

HRS Scientific Sessions: Boston Scientific LBCT

During the Heart Rhythm Scientific Sessions this week, Boston Scientific announced positive LBCT data underscoring the safety and efficacy of multi-site pacing (MSP) over conventional cardiac resynchronization therapy (CRT), as well as poster presentations on real-world use of the WATCHMAN Left Atrial Appendage Closure (LAAC) device and next-generation WATCHMAN FLX LAAC device as alternatives to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation.

What are the Most Commonly Performed Surgeries?

Whether you are trying to learn more about a surgery you are planning to have or find out what the most common procedures are, this list is here for you. Read more.

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

Exogenesis Corporation announced today that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its first proprietary soft tissue repair device, Exogenesis Hernia Mesh. Exogenesis expects feedback from the FDA during the next quarter and anticipates entering the US market with Exogenesis Hernia Mesh following FDA premarket clearance.

Dmitry Shashkov, President and CEO of Exogenesis commented, “We are excited to reach this important milestone in our product development. Our Accelerated Neutral Atom Beam1 (“ANAB”) surface treatment technology is already being deployed on other FDA-cleared devices, however Exogenesis Hernia Mesh is our first proprietary product developed entirely in-house. ANAB has the bioactive potential to improve medical device implant responses in man and we are excited to bring this exciting technology one step closer to the clinical community.”

Exogenesis will highlight the Exogenesis Hernia Mesh and other developments of its ANAB enhanced medical device technology during two upcoming international conferences: The International Symposium on Surfaces and Interfaces for Biomaterials (ISSIB, Quebec City, Canada, July 22-25 2019) and American Vacuum Society International Symposium and Exhibition (AVS-66, Columbus, Ohio, October 20-25 2019).

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.