The Medical Device Manufacturers Association (MDMA) has elected Outset Medical Chair and CEO Leslie Trigg as chair of the trade group’s board of directors. MDMA announced the leadership change today, following the Washington, D.C.-based industry association’s annual meeting last week. “Medical technology innovators are at the forefront of improving patient outcomes and reducing the cost […]
Medical Device Manufacturers Assn. (MDMA)
Medtech gets behind breakthrough device law for seniors
Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation. Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that […]
CMS delays Medicare payments for breakthrough devices until December
Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years. Immediately […]
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, […]
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 […]
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 […]
House votes (again) to repeal medical device tax
The U.S. House of Representatives voted 283-132 this week to repeal the 2.3% tax levied upon medical devices as part of the Affordable Care Act. The medical device tax, which has long been decried by the industry as a measure that squashes innovation and kills jobs, has been on hold since 2014. The tax’s moratorium […]
Why medtech should keep its lobbying expectations low in 2017
Political chaos means fewer opportunities for the medtech industry to get much done in Congress this year, says Clayton Hall, VP of government affairs for the Medical Device Manufacturers Assn. When it comes to permanent repeal of the 2.3% medical device excise tax that was part of the 2010 Affordable Care Act, there are fewer legislative opportunities, […]