Amy J. Reed Collaborative/HARMS Petition HHS and FDA to Take Action on Vena MicroAngioscope

06.22.26 — Northeastern Law professors David A. Simon and Hooman Noorchashm, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC) and officers of Harmed Americans for Reform in Medical-Device Safety (HARMS), have filed a citizen petition with the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) requesting action regarding the Vena MicroAngioscope System, a vascular imaging device manufactured by Vena Medical Holdings Corp.

“New devices are critical to patient health. But whether a new significant device is safe and effective cannot be reliably determined without clinical trials to evaluate its safety and effectiveness. Medical innovation and patient safety depend on robust clinical trial data,” said Simon, a healthcare law expert.

The petition explains that the FDA cleared the Vena MicroAngioscope in 2025 for use in peripheral vasculature and in 2026 expanded that clearance to peripheral and coronary vessels — but that neither clearance was supported by sufficient clinical trial data. Despite labeled indications limited to peripheral and coronary vascular use, the device is being promoted and used in neurovascular settings, including for acute ischemic stroke thrombectomy, without an FDA-approved Investigational Device Exemption (IDE). The only published study of the device is a small, single-arm, first-in-human observational study of 31 patients with no randomized comparison to the standard of care and no long-term follow-up. The petition requests that the FDA require the manufacturer and any sponsors investigating the device for neurovascular use to obtain an IDE, clarify whether neurovascular use falls within the existing label and — if it does not — issue an It Has Come to Our Attention Letter to Vena Medical, and require the manufacturer to conduct postmarket surveillance of the device.
>> View the FDA Docket

“When new and non-standard 510(k) devices are used clinically, especially when such uses are off-label, it is critically important for MedTech manufacturers to refrain from overt marketing and promotion of such uses. In this scenario, clinicians should seek IRB guidance and IDE authorization from FDA for such use of new and non-standard 510(k) devices in properly designed clinical trials to establish safety, efficacy and non-inferiority in the target patient population,” said Noorchashm, an internationally recognized medical device safety expert.

The Amy J. Reed Collaborative for Medical Device Safety, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increased awareness, fostering collaboration, and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability. Harmed Americans for Reform in Medical-Device Safety (HARMS) is a 501(c)(3) not-for-profit corporation whose mission is to advance medical device safety through advocacy, outreach, and organizing.