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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…

Regulatory Affairs / Small Business

MY01 Inc. Receives FDA Clearance for the MY01 Continuous Compartment Pressure Monitor as an Aid in Diagnosis of Compartment Syndrome

MY01’s device helps diagnose acute compartment syndrome (ACS), a relatively common and potentially lethal muscle condition notably suffered by Tiger Woods in his car accident last February.

COVID-19

O2TODAY and SINTX Technologies Enter Commercialization Agreement to Fight COVID-19

O2TODAY (“O2TODAY”), a mask company that develops, manufactures and commercializes face masks for medical and non-medical uses, and SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”) (www.sintx.com), an original…

Haemonetics To Acquire Cardiva Medical, Inc. To Expand Hospital Portfolio

Haemonetics Corporation (NYSE: HAE) (“Haemonetics”), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, today announced that it has entered into a definitive…

SBA Announces Recipients of Tibbetts Awards for Demonstrating Significant Economic and Social Impact from R&D Funding

Today, the U.S. Small Business Administration announced 38 companies, seven organizations and 14 individuals as the winners of the prestigious Tibbetts Award for their accomplishments in creating cutting-edge technologies.

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