The FDA will continue its efforts to find alternative medical device sterilization methods to ethylene oxide (EO), even though a major EO plant is slated to reopen. Yesterday, medtech sterilization company Sterigenics and the state of Illinois announced they had reached a proposed consent agreement to reopen a plant in Willowbrook, Ill., which the state shut down in […]
Sterigenics moves to upgrade shuttered device sterilization plant
Sterigenics said today that it has applied for permits to upgrade emissions controls at its Willowbrook, Ill. medical device sterilization plant, which had sterilized thousands of devices daily until its Feb.15 shutdown. The Illinois Environmental Protection Agency (EPA) closed the Willowbrook plant, citing excessive emissions of the sterilant ethylene oxide (EO), based on a federal […]
Tariffs on Mexico could hit medtech hard
The medical device industry is bracing for a potential multi-million-dollar fallout from a proposed tariff on all products coming into the United States from Mexico. The StarTribune of Minneapolis reports that the cost of these devices could skyrocket and that the effects would be widespread within the industry, costing tens of millions of dollars a […]
AdvaMed head Whitaker lauds FDA, ignores recent device issues in NYT Op-ed response
AdvaMed prez & CEO Scott Whitaker shot back at a New York Times op-ed published earlier this month pushing for tighter FDA regulations, calling the federal watchdog “the gold standard the world over” while avoiding commenting on any of the issues raised in the original piece. Last week, the Times cited a number controversial devices […]
Sterilization plant closures: Here’s why you need to care
The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, […]
Nevro taps ex-Thoratec CEO Grossman | Personnel Moves, March 20, 2019
Nevro Corp. (NYSE:NVRO) said yesterday that it named former Thoratec CEO Keith Grossman to replace president & CEO Rami Elghandour after striking a deal with one of its investors, Broadfin Capital. Grossman re-joined Thoratec after taking over at Conceptus in December 2011 and leading it to a $1.1 billion sale to Bayer in June 2013 (he’d […]
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 […]
Trump, industry groups praise outgoing FDA chief Gottlieb
In the wake of the surprising news that FDA commissioner Dr. Scott Gottlieb plans to resign next month, the Trump Administration and industry groups expressed support for the outgoing chief. In a letter to FDA employees, Gottlieb said that the challenge of being apart from his family for the last two years motivated his decision […]
Sen. Warner enlists healthcare industry help on cybersecurity
U.S. Senator Mark Warner (D-Va.) wrote a letter to several healthcare organizations yesterday, asking their help in improving cybersecurity in the industry. A member of the Senate Finance Committee and chair of the Senate cybersecurity caucus, Warner pointed to apparent gaps in oversight, expressed concern about the impact of cyberattacks on the health care sector, […]
AdvaMed president & CEO Scott Whitaker to participate in keynote interview at DeviceTalks Boston 2019
WTWH Media and MassDevice.com announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting […]
3M names CEO Roman as board chair | Personnel Moves – February 7, 2019
3M (NYSE:MMM) said yesterday that its board of directors nominated CEO Mike Roman as its new chairperson, with current exec chair Inge Thulin announcing their intention to retire. The move is slated to take effect following the St. Paul, Minn.-based company’s annual meeting of shareholders on May 14. “Under Inge’s leadership, 3M evolved into a more […]
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