Medicare coverage for FDA-designated breakthrough medical devices will have to wait, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule in January granting coverage for breakthrough devices the same day as their FDA approvals. The rule was supposed to take effect March 12, but CMS has postponed the Medicare Coverage of […]
Medical Device Manufacturers Association
Biden’s COVID-19 response will make manufacturers busy
Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic. In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, […]
Medtech takes a stand on D.C. rioting
The medtech industry has joined other business and industry groups in condemning Tuesday’s siege of the Capitol in Washington, D.C. by supporters of President Donald Trump. The National Manufacturers Association called for Vice President Mike Pence to invoke the 25th Amendment to remove President Donald Trump from office. The Business Roundtable tweeted a call for an end […]
MDMA’s Leahey says two-party control can benefit medtech
Splitting party control over the White House and Congress may concern some, but this dynamic has worked well for the medtech industry in the past, according to Mark Leahey, president of the Medical Device Manufacturers Association. In an interview in this week’s DeviceTalks Weekly Podcast, Leahey said the industry sees long-lasting benefits when both parties […]
Please pass the podcast – Enjoy a feast of insights from Spencer Stiles (Stryker) Art Collins (Explorer) and Mark Leahey (MDMA)
DeviceTalks Weekly listeners will need some gravy to digest this Thanksgiving feast-sized podcast featuring news and insights from three stellar guests in addition to two new installments of #2minutedetalks chapters from Delve Inc. and Explorer Surgical. This week we visit with… Mark Leahey, president of the Medical Device Manufacturers Association, who explains where medtech might […]
COVID-19 is here: Medtech may never be the same
The COVID-19 pandemic promises to change nearly every aspect of our lives — remote working, social distancing and Zoom-bombing likely will be part of our professional lexicon for years to come. But the pandemic also will bring big changes to the medtech industry, which got caught in the center of some political, geopolitical and yes […]
Permanent repeal of medical device tax headed to president’s desk
This article has been updated with comments from the Medical Alley Association and the Massachusetts Medical Device Industry Council (MassMEDIC). Both houses of Congress have now passed the 2020 federal spending package, which includes a provision to permanently repeal the 2.3% medical device excise tax. The package of eight spending bills awaits the signature of […]
Medtech trade lobbies unite for anti-tax push
A group of medical device industry trade associations are joining together to push the U.S. Congress toward repealing the medical device tax that’s been in abeyance since 2015. MDMA, AdvaMed, MITA and a group of medical innovators, physician inventors, patient groups and more today sent a letter urging congressional leadership to permanently repeal the medical […]
MiMedx names Wright as CEO | Personnel Moves – May 9, 2019
MiMedx (NSDQ:MDXG) said today that it it named Timothy Wright as its new chief exec, effective May 13. Wright will replace David Coles, who has served as the interim CEO since last July, the Marietta, Ga.-based company said. MiMedx said that Wright has more than 30 years of experience in pharma, medtech and biotech. Prior to […]
Medical device tax repeal bill reintroduced in U.S. Senate
U.S. Senator and Democratic presidential candidate Amy Klobuchar (D-Minn.) reintroduced a bill to permanently repeal the 2.3% federal excise tax on medical device sales, with a new co-sponsor. Sen. Pat Toomey (R-Penn.) has signed on to co-sponsor, replacing Sen. Orrin Hatch (R-Utah), who did not run for re-election last fall. The medical device tax went […]
FDA opts not to change device class definitions
The medtech industry appears to have won a round in the regulatory arena. The FDA issued a final rule amending its regulations on classifying and reclassifying medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in 2012. Published today in the Federal Register, the rule says it “provides for the […]
