VERO Biotech has issued a Software of Correction

VERO Biotech LLC, an Atlanta, Georgia-based biotechnology business dedicated to saving lives, reducing pain, and improving the health economics of care, has voluntarily provided a remedy to Software version 2.2.3 for GENOSYL® DS devices is a Class 1 recall. VERO Biotech collaborated with the FDA to issue the recall notice and take corrective action. As a result, all GENOSYL® DS devices affected by the recall have been upgraded to the most recent software version available on May 14, 2021.

This fix does not necessitate the removal of any GENOSYL® DS devices. VERO is still working with the FDA to resolve the matter. Nitric oxide is a potent chemical that is important in a variety of biological processes. For example, Nitric oxide is used in adult respiratory distress syndrome and neonatal persistent pulmonary hypertension to target the vascular smooth muscle cells surrounding the tiny resistance arteries in the lungs.

The only option to supply iNO before the approval of the GENOSYL Delivery System was through massive, pressurized gas cylinders and accompanying delivery systems. In term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension, GENOSYL® (nitric oxide) gas for inhalation is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in conjunction with ventilatory support and other appropriate agents.

VERO Biotech‘s lead is GENOSYL DS. Large nitric oxide tanks and the related logistical load are no longer required with our patented delivery technology. The GENOSYL DS is a tankless, portable system with redundant backup capabilities.