SurgiBox, a medical technology company committed to improving access to safe, clean surgery at the point of need, announced today it has received the CE Mark under MDR for the medical devices that comprise its flagship product, the SurgiField System.
The CE Mark under the European Union’s Medical Device Regulation (MDR 2017/745) standards certifies compliance with stringent health, safety, and environmental protection standards required for medical devices in the European Union. SurgiBox received CE Mark approval today for the SurgiBubble, the sterile device component of its SurgiField System, an ultraportable technology platform integrating intraprocedural environmental control and personal protective equipment. Combined with the previously approved electronic filtration system, the complete SurgiField System is now ready for market deployment.
This milestone, spearheaded by SurgiBox co-founder Sashidhar Jonnalagedda and CTO Atif Rakin, marks the successful certification of conformity with the EU’s Medical Device Regulation (MDR 2017/745) and ISO 13485:2016 standards - paving the way for commercial distribution across Europe and other key international markets.
The SurgiField System is a first-of-its-kind, ultraportable surgical environment that protects both patients and surgical teams from cross-contamination with bodily fluids. Medical professionals apply the disposable SurgiBubble to the patient's surgical site using standard draping techniques. They then activate operating room-quality HEPA airflow through the battery-powered Smart Control Module and pop-up frame. Surgeons insert their arms through integrated sleeve ports - similar to putting on surgical gowns - and proceed with the procedure as normal. The CE Mark approval is supported by comprehensive testing, including preclinical laboratory studies and usability data. These studies consistently demonstrated that the SurgiBubble protects the surgical site from the outside environment. Additionally, the SurgiField System seamlessly integrates into surgical workflows across diverse environments, from field conditions to established medical facilities.
