WASHINGTON, D.C. – Today AdvaMed President and CEO Scott Whitaker released the following statement about AdvaMed’s participation on the HHS Vaccine Consultation Panel.
Press Release | January 15, 2021
AdvaMed Praises Expanded Coverage of FDA-Designated “Breakthrough” Medical Technologies for Medicare Beneficiaries
Press Release | January 12, 2021
WASHINGTON, D.C. – Today, AdvaMed President and CEO Scott Whitaker commended CMS on the rule the agency released today establishing a new coverage pathway – MCIT – for breakthrough medical technologies:
Press Release | January 12, 2021
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today named DeChane Dorsey the new Executive Director of AdvaMed Accel, the division within AdvaMed dedicated to the needs of small and start-up medical technology manufacturers. DeChane was previously AdvaMed’s Vice President of Payment and Health Care Delivery Policy, a role she has held since 2006.
February 1, 2021 |
AdvaMed and Porzio Life Sciences have teamed up to offer a four-part virtual program to help you and your team mitigate the burden of compliance. These interactive programs will provide you with a... Read More
February 22, 2021 to February 23, 2021| Online
FDA and industry experts are coming together to review the basics of 510(k) submissions. This unique opportunity will help you better understand the FDA perspective on 510(k) submissions, from... Read More
February 24, 2021 | Online
FDA and industry experts will share the guidelines governing when an investigational device exemption is required. Course instructors will review the purpose of an IDE, share tips for making the best... Read More
February 25, 2021 to February 26, 2021| Online
Using real-world case studies, this workshop will walk you through the practical steps of filing a PMA and offer you actionable insights on how to best navigate the PMA submission process. Steps... Read More
SBA Announces Recipients of Tibbetts Awards for Demonstrating Significant Economic and Social Impact from R&D Funding
Washington, Jan. 14, 2021 (GLOBE NEWSWIRE) -- 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. The Tibbetts Awards, named after Roland Tibbetts, the founder of the SBIR Program, honors these awardees for the exceptional successes they achieved through SBA’s Small Business Innovation Research (SBIR) and Small Business...
Ortho’s VITROS® SARS-CoV-2 Antigen Test for Accurate, Mass-Scale COVID-19 Testing is the First Widely-Available, High-Volume Test to Receive FDA Emergency Use Authorization
Ortho’s VITROS® SARS-CoV-2 Antigen Test is the first high-volume COVID-19 antigen test to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA). With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour. The test is run on Ortho’s high-volume VITROS® Systems, which are installed in over 5,600 laboratories around the world with 1,500 installed in the U.S. RARITAN, N.J. (January 12, 2021) – Ortho...
SCOTTSDALE, Ariz., -- Regenesis Biomedical, Inc., a medical device company focused on safe, non-drug, pain management, announced today that the Board of Directors has unanimously elected Mr. Tom Eisiminger, Jr., as the next President and Chief Executive Officer (CEO), and member of the Board of Directors. Mr. Eisiminger succeeds Mr. Scott Brooks who recently retired. Scott Brooks' career spanned senior management positions in BSN medical, KCI, Hill-Rom Company and Kimberly-Clark Healthcare,...
SANTA MONICA, Calif., -- Avenda Health, a software and medical device company that spun out of UCLA, announced today that the Food and Drug Administration (FDA) has cleared their focal laser ablation system. Avenda Health's image-guided focal laser ablation system is designed to ablate soft tissue in a physician's office. It uses a proprietary laser needle and thermal optical sensor to precisely target and treat soft tissue while minimizing the impact on healthy tissues. The company will...
Haemonetics (NYSE:HAE) announced that it received FDA 510(k) clearance for its NexSys PCS system with Persona technology. Boston-based Haemonetics’ new, proprietary Persona technology customizes plasma collection based on an individual donor’s body composition, according to a news release. NexSys PCS (plasma collection system) with Persona is intended for use as an automated cell separator system and blood component collector with single-use, sterile, disposable sets, with or without saline...
January 15, 2021 - 3:47pm