CVRx CEO Nadim Yared has emerged as a fearless, outspoken leader in medtech. Tom Salemi, Editorial Director, DeviceTalks Throughout his career, Nadim Yared — the CEO of surging neurostimulation company CVRx — has pushed to assume new responsibilities and duties. However, during one moment in 2006, Yared adamantly refused to discuss leaving Medtronic to become CEO of […]
Medical device tax is permanently repealed
President Donald Trump has signed into law the 2020 federal spending package, which includes a provision to permanently repeal the 2.3% medical device excise tax. Trump signed off on the spending bills on Dec. 20, providing the medical device industry a win that it has sought for nearly a decade. The tax was part of […]
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 […]
Medical device tax on track for permanent repeal
A bipartisan spending bill unveiled today by Congressional leaders would permanently repeal the 2.3% medical device excise tax. The spending bill, which must pass both houses of Congress and be signed by President Trump to take effect, would fulfill the widespread wishes of the medtech industry. The tax went into effect in 2013 and has […]
Senate confirms Dr. Stephen Hahn to lead FDA
The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer […]
House bill asks CMS to cover breakthrough devices for Medicare patients
U.S. Rep. Suzan DelBene (D-Wash) reintroduced a bill today to improve Medicare patient access to breakthrough medical devices. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) would require Medicare to temporarily cover all devices approved through the FDA’s breakthrough pathway for three years, during which the Centers for Medicare and […]
Medical device tax will cost 20,000 jobs, report says
The medical device excise tax could result in a loss of 21,390 full-time jobs and a GDP reduction of $1.7 billion, according to a report from the Tax Foundation, a nonpartisan, business-friendly think tank. According to the report, the tax is projected to raise about $25 billion over the next 10 years. Other research from […]
Federal agencies will control the fate of medtech’s most-used sterilization method
The fate of the medical device industry’s most widely used sterilization process lies in the hands of the Environmental Protection Agency. The EPA gave the medtech industry mixed signals in November about the gas used to sterilize billions of devices annually. The agency said it might seek to cut industrial emissions of ethylene oxide (EtO) […]
Insights from Cathy Burzik’s 40 years in the healthcare industry
From the early days of software development to personalized cell and gene therapies, Cathy Burzik has witnessed a lot of technological evolution over the course of her 40-year career in the healthcare industry. She sat down with DeviceTalks’ former program manager Sarah Faulkner for an interview at AdvaMed’s The MedTech Conference this year, where she […]
EPA proposes drastic cuts to EtO emissions nationwide
The EPA has announced plans to greatly reduce industrial emissions of ethylene oxide (EtO), the carcinogenic gas used to sterilize billions of medical devices annually. The agency proposed cutting EtO emissions from industrial facilities by 93% as part of amendments to the Miscellaneous Organic Chemical Manufacturing National Emission Standards for Hazardous Air Pollutants (NESHAP) to reduce hazardous […]
Battles over sterilization plants intensify as industry warnings about shortages grow
The fight over plants that use ethylene oxide (EO) to sterilize medical devices is escalating across the country. New proposed legislation in Illinois would ban the use of the carcinogenic gas by sterilizers by 2021 and by hospitals by 2022, according to reports by the Chicago Tribune. A legislative hearing on the bill is scheduled for […]
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