WASHINGTON, D.C. – Today AdvaMed President and CEO Scott Whitaker sent a letter to President Biden affirming the industry’s support of the administration’s national COVID-19 strategy and sharing the industry’s perspective on invocation and use of the Defense Production Act (DPA).
AdvaMed Letter to President Biden on Defense Production Act: Ready to Continue Industry Efforts to Defeat COVID-19
Press Release | January 22, 2021
Blog Post | January 22, 2021
Last week, we celebrated an important CMS policy update: Under a new rule, called Medicare Coverage of Innovative Technology (MCIT), as soon as the FDA approves a new breakthrough technology, Medicare can cover that breakthrough technology. Today, in an op-ed in Morning Consult, AdvaMed President and CEO Scott Whitaker encouraged the Biden administration to work with our industry to implement and strengthen the rule, saying, “Too many seniors’ lives depend on it.”
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
BOSTON, Jan. 20, 2021 -- 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 agreement to acquire privately-held Cardiva Medical, Inc., ("Cardiva") an industry-leading manufacturer of vascular closure systems based in Santa Clara, California. Under the terms of the agreement, Haemonetics will acquire Cardiva for an...
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...
January 26, 2021 - 11:07am
January 25, 2021 - 9:47pm
The new Medicare Coverage of Innovative Technology (MCIT) rule will have a major impact on Medicare patients and th… https://t.co/uWVu6uywqU