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Workforce Advancement

TEAMFund Releases 4th Annual Impact Report, Announces Raise of $150M Fund, and Grants 5th Annual Global Health Innovation Award for Female-Founded Medtech Companies

TEAMFund, a 501(c)(3) Public Charity and a For-Profit Impact Fund whose mission is to enhance patient access to medical technology in low resource settings, announced at The AdvaMed® Medtech Conference,…

Regulatory Affairs

Renovia Receives FDA Clearance for leva® Pelvic Health System as First-line Treatment for Chronic Fecal Incontinence

Renovia Inc., an AdvaMed® member and developer of non-surgical, treatments for female pelvic floor disorders, announced the U.S. Food and Drug Administration (FDA) has cleared its leva® Pelvic Health System…

BlueWind Medical Raises $64 Million to Fund Innovative Technology for Overactive Bladder Treatment

BlueWind Medical, Ltd., AdvaMed® member and developer of the innovative RENOVA iStim™ implantable tibial neuromodulation (iTNM) device for treatment of Overactive Bladder, today announced the addition of Charles F. (“Chuck”)…

BlueWind Medical Ltd. Appoints Charles F. Cargile as Chief Financial Officer

BlueWind Medical, Ltd., AdvaMed® member and developer of the innovative RENOVA iStim™ implantable tibial neuromodulation (iTNM) device for treatment of Overactive Bladder, today announced the addition of Charles F. (“Chuck”)…

Regulatory Affairs

Cook Medical receives FDA Breakthrough Device Designation for Zenith® Thoraco+ Endovascular System

AdvaMed® member Cook Medical’s Zenith® Thoraco+ Endovascular System (Thoraco+) has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).

Diagnostics / Global & Trade

Canadian Hospital Specialties Limited Joins AdvaMed®, the World’s Leading Medical Technology Trade Association

February 9, 2022  — Canadian Hospital Specialties Limited (CHS) announced today that it has joined the Advanced Medical Technology Association® (AdvaMed®), the world’s leading trade association representing more than 400…

Global & Trade / Regulatory Affairs

B. Braun Receives FDA Approval of Daytona Beach Pharmaceutical Manufacturing Site

Hyalex Orthopaedics, a privately-held medical device company developing transformational cartilage biomimetic products, today announced the appointment of Carl Vause as its new chief executive officer and president.

Small Business

Hyalex Orthopaedics Appoints Carl Vause, Orthopaedic Industry Veteran, as Chief Executive Officer and President and Names Mike Hawkins, Ph.D., Chief Technical Officer

Hyalex Orthopaedics, a privately-held medical device company developing transformational cartilage biomimetic products, today announced the appointment of Carl Vause as its new chief executive officer and president.

Small Business

MY01 Continuous Compartmental Pressure Monitor granted Breakthrough Device Designation from the FDA

MY01 Inc. receives their first-ever “Breakthrough Device” designation by the FDA in October, joining a select list of Orthopaedic companies to receive this designation since the program began in 2016.

COVID-19 / Government & Legislative Affairs / Regulatory Affairs

BD Unveils Nebraska-Based Manufacturing Capacity to Support U.S. Vaccination Agility and Preparedness

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has strengthened the U.S. government’s access to safety injection devices through increased manufacturing capacity…

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