Researchers at Children’s Hospital Los Angeles and the University of Southern California said the FDA granted humanitarian use device status to the fetal micro-pacemaker they designed.
The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.
MASSDEVICE ON CALL — U.S. healthcare regulators released new documents in efforts to clarify the FDA’s Humanitarian Device Exemption pathway, a less-stringent review process for medical devices that treat rare diseases.
The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients.
Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.
XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.
The Cambridge, Mass.-based company said it is gearing up for safety studies in 5 patients over 15 months, and is shooting for Institutional Review Board (IRB) approval at Massachusetts General Hospital.
The designation means the InVivo scaffold can seek expedited approval from the FDA for a pivotal trial of the device. HUD-based exemptions cover devices aimed at treating rare diseases and health problems, so-called "orphan" conditions.
SynCardia Systems won 2 new Humanitarian Use Device designations for its 50cc Total Artificial Heart as a cardiac bridge transplant device.
The new HUD designations apply to use with children, smaller women and other people with small stature. The Tuscon, Ariz.-based device manufacturer designed this device as a smaller version of its 70cc temporary Total Artificial Heart, approved in 2004, according to a press release.