Medical Device Manufacturers Association Archives

MDMA elects Outset CEO Leslie Trigg as chair

Outset Medical Chair and CEO Leslie Trigg [Photo courtesy of Outset Medical]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 of care, and I am honored to lead MDMA as they continue their tremendous work as the leading voice of our industry,” Trigg said in a news release. “Modern technology is impacting when, where and how healthcare can be delivered. Together, we have the privilege of imagining what the future of healthcare could look like, and turning invention into reality.”

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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 upon taking office, the Biden administration asked federal agencies to consider delaying the effective date of rules published in the Federal Register to review questions of fact, law and policy the rules may raise. CMS officials decided that coverage of breakthrough devices warranted further review.

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CMS delays breakthrough device Medicare coverage

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 Innovative Technology (MCIT) final rule by 60 days to give the public more opportunities to comment, the agency said in a Federal Register notice.

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Biden’s COVID-19 response will make manufacturers busy

[Image courtesy of Biden for President]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, face shields and other PPE, with an eye toward boosting American manufacturing to reduce reliance on other countries. The president also announced his intention to invest $25 billion in a vaccine manufacturing and distribution plan that will provide vaccines to all Americans, free of charge.

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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 to the violence and for a peaceful transition of power to President-elect Joe Biden’s administration.

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