Top News

Press Release | December 13, 2019
WASHINGTON, D.C. – In an op-ed published today in Morning Consult, AdvaMed President and CEO Scott Whitaker urges Congress to act before the medical device excise tax comes back into effect Jan. 1.
Press Release | December 12, 2019
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement today from President and CEO Scott Whitaker regarding the U.S. Senate’s confirmation of Dr. Stephen Hahn to serve as the new FDA Commissioner:
Press Release | December 12, 2019
WASHINGTON, D.C. – In today’s Wall Street Journal, the editorial board wrote that Congress “should stop a return of the destructive” medical device excise tax scheduled to go into effect on Jan. 1.

Events

January
15
January 15, 2020 |
Hundreds of new NMPA regulatory policies, guidelines, standards and announcements were released in 2019. These updates and changes impact the complete product life cycle from new submissions to... Read More
February
11
February 11, 2020 to February 12, 2020
| 701 Pennsylvania Avenue #800, Washington, DC
Led by industry and FDA experts, this workshop will provide an in-depth overview of how organizations can best tackle complaints, MDRs and recalls. Together with industry and FDA experts, we've... Read More
February
24
February 24, 2020 to February 25, 2020
| Irvine, CA
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
26
February 26, 2020 | Irvine, CA
During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required. Agenda... Read More
February
27
February 27, 2020 to February 28, 2020
| Irvine, CA
Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a Premarket Approval. Agenda topics... Read More

Industry News

SAN JOSE, Calif., December 3, 2019 — Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease today announced it has closed a Series C funding led by Ally Bridge Group (ABG). ABG is a global life science-focused group with a successful investment record globally in supporting high-growth innovative life science companies. “Securing this financing further confirms continued investor confidence in Venclose’s...
Where Women Work
Prime employers for women BD and Medtronic both attended the prestigious MedTech Conference and addressed industry delegates. The conference saw more than 3,300 of the world’s top medical technology executives gather in Boston, USA, for educational programming, valuable networking and business development opportunities. Positioning corporate diversity and inclusion for success BD’s VP of Inclusion & Diversity Johnel Evans joined other executive leaders on a panel discussing positioning...
Eight New York members of Congress are urging House and Senate leadership to address the Affordable Care Act's medical device tax before the end of the year.  The bipartisan group of lawmakers want to repeal or delay the excise tax, which was included in the 2010 health care law as a revenue generator. The 2.3% tax on the sale of medical devices took effect in 2013, but Congress acted in 2015 to impose a two-year moratorium. In 2017, Congress extended the moratorium on the medical device tax...
NEW YORK, Sept. 18, 2019 /PRNewswire/ -- TEAMFund ("Transforming Equity and Access for MedTech") -- a novel hybrid organization combining a Non-Profit with a For-Profit Fund investing in medical technology companies that improve patient access in low-resource settings -- today announced the Final Closing of its $30mm Inaugural Fund. The Fund is led by longtime MedTech investor, Yousuf Mazhar and Tim Ring, former Chairman and CEO of C.R. Bard. TEAMFund was the inspiration of Ms. Kathryn Gleason...
BOSTON--(BUSINESS WIRE)--ApiFix Ltd., a leading motion-preservation scoliosis correction company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) via a Humanitarian Device Exemption (HDE) to market the Minimally Invasive Deformity Correction (MID-C) system for the treatment of progressive adolescent idiopathic scoliosis (AIS). AIS is the most common type of scoliosis with no identifiable cause and affects 2%-3% of children between ages 10 to 21....

Twitter Feed

December 13, 2019 - 4:15pm
employees are bracing for job losses and research and development cuts should the medical device tax be re… https://t.co/du6mGhC8MM
December 13, 2019 - 2:51pm
“The tax has been suspended for longer than it was ever in place precisely because everyone recognizes these conseq… https://t.co/2GYLg16Pmc