November 2, 2021: The evidence does not support the use of the Endologix AFX EVAR devices, and the AFX2 device should not remain on the market while waiting for longer term data to determine if it is as safe as other EVAR devices.
Read More »On Medical Treatments & Products
Testimony of Dr. Diana Zuckerman, NCHR, at the FDA MDUFA Meeting
September 30, 2021: Dr. Diana Zuckerman testifies to the FDA regarding the lack of diversity and inclusion in medical device trials pointing out that most medical companies do not adequately study safety and effectiveness in women, older patients, and people of color.
Read More »NCHR’s Testimony to FDA Regarding Boosters for Pfizer’s COVID-19 Vaccine
September 17, 2021: The data provided for this meeting do not allow us to draw confident conclusions, and a premature decision will make it impossible to do the research necessary to draw scientific conclusions.
Read More »NCHR’s Testimony to FDA on the TriGUARD 3 Device
NCHR’s Dr. Meg Seymour testified at an FDA Advisory Committee about why the TriGUARD 3 device is not substantially equivalent to its predicate device, Sentinel. She explained that TriGUARD 3 failed to meet its primary effectiveness endpoint, with patients twice as likely to have a stroke compared to the control group.
Read More »NCHR’s Testimony to FDA on the TransMedics® Organ Care System™ (OCS) Liver System
NCHR Fellow Dr. Meg Seymour testified at an FDA Advisory Committee regarding concerns about the TransMedics Organ Care System (OCS) Liver System. While the device showed superiority on a surrogate endpoint, it did not improve survival compared to traditional cold storage and introduced additional risks caused by device malfunction and organ damage.
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