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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…

Coverage & Payment / Regulatory Affairs / Small Business

Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer® System Procedure

Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid…

Coverage & Payment / Regulatory Affairs / Small Business

Rhaeos, Inc. Awarded $4 Million NIH SBIR Grant to Expand Quantitative Measurement Capabilities of its FlowSense™ Noninvasive Wireless Sensor

Rhaeos, Inc., a private medical device company focused on the care of patients with hydrocephalus, announced today it was awarded a $4 million, multi-year grant from the National Institutes of…

Coverage & Payment / Regulatory Affairs / Small Business

Vibrato Medical Closes $4M Series A Funding Round and Receives $1.5M NIH Grant

Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that it has closed a $4M Series A funding round led by the Horowitz Group, a…

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