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Medical Device Manufacturers Association

CMS delays breakthrough device Medicare coverage

March 19, 2021 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: AdvaMed, Centers for Medicare and Medicaid Services (CMS), FDA, Medical Device Manufacturers Association

Biden’s COVID-19 response will make manufacturers busy

January 21, 2021 By Nancy Crotti

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, […]

Filed Under: Business/Financial News, Diagnostics, Distribution, Drug-Device Combinations, Featured, Medical Device Manufacturers Assn. (MDMA) Tagged With: 3m, AdvaMed, BD, becton dickinson, International Safety Equipment Association, Medical Device Manufacturers Association, Medline Industries Inc., PPE

Medtech takes a stand on D.C. rioting

January 7, 2021 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Featured Tagged With: AdvaMed, B. Braun, becton dickinson, Donald Trump, Johnson & Johnson, Medical Device Manufacturers Association

MDMA’s Leahey says two-party control can benefit medtech

November 23, 2020 By Tom Salemi

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 […]

Filed Under: Featured, Medical Device Manufacturers Assn. (MDMA) Tagged With: Medical Device Manufacturers Association

Please pass the podcast – Enjoy a feast of insights from Spencer Stiles (Stryker) Art Collins (Explorer) and Mark Leahey (MDMA)

November 20, 2020 By Tom Salemi

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 […]

Filed Under: Featured, Medical Device Manufacturers Assn. (MDMA), Orthopedics, Spine, Surgical Tagged With: BD, becton dickinson, Boston Scientific, Delve, Explorer Surgical, Johnson and Johnson, Medical Device Manufacturers Association, Medtronic, Stryker

COVID-19 is here: Medtech may never be the same

May 1, 2020 By Tom Salemi

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 […]

Filed Under: Business/Financial News, Contract Manufacturing, Distribution, Featured, Food & Drug Administration (FDA), Medical Device Manufacturers Assn. (MDMA), Patient Monitoring, Research & Development Tagged With: 3m, Abbott, Beth Israel Lahey Health, emerson, Fang Consulting, FDA, Hogan Lovells, lrvhealth, Mayo Clinic, Medical Device Manufacturers Association, Rev1 Engineering, Stress Engineering Services, The Clinicians Exchange

Permanent repeal of medical device tax headed to president’s desk

December 19, 2019 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Featured Tagged With: AdvaMed, MassMEDIC, Medical Alley Assn., Medical Device Manufacturers Association, medical device tax

Medtech trade lobbies unite for anti-tax push

September 24, 2019 By Sean Whooley

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 […]

Filed Under: Business/Financial News Tagged With: AdvaMed, Avalign Technologies, Bayer, Medical Device Manufacturers Association, Medical Imaging & Technology Alliance (MITA), medicaldevicetax, Stryker

MiMedx names Wright as CEO | Personnel Moves – May 9, 2019

May 9, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Amplifon, California Life Sciences Assn, Capsule Tech Inc., Cerebrotech Medical Systems, factorycro, Medical Device Manufacturers Association, Medicines & Healthcare products Regulatory Agency (MHRA), MiMedx Group Inc., Monarch Medical, sentiar, Xtant Medical

Medical device tax repeal bill reintroduced in U.S. Senate

March 7, 2019 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Medical Device Manufacturers Assn. (MDMA), News Well Tagged With: AdvaMed, Medical Alley, Medical Device Manufacturers Association, medicaldevicetax, ussenatoramyklobuchar, ussenatorpattoomey

FDA opts not to change device class definitions

December 17, 2018 By Nancy Crotti

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 […]

Filed Under: Food & Drug Administration (FDA), Medical Device Manufacturers Assn. (MDMA), News Well, Regulatory/Compliance Tagged With: AdvaMed, FDA, Medical Device Manufacturers Association

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