Medtech company SurgiBox has received the CE Mark under MDR for the medical devices that comprise its flagship product, the SurgiField System.
That includes the SurgiBubble, the sterile device component of its SurgiField System, a portable 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.
The SurgiField System is a portable 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 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.
Timely access to safe, clean surgery is a massive challenge globally across the spectrum of healthcare resources, with an estimated 5 billion people chronically lacking consistent access to safe surgery, resulting in 18 million preventable deaths annually. Even in high-resource settings with quality surgical facilities, ballooning costs, logistical challenges, and rising wait times have pushed surgeons and health systems to look toward alternative settings like hospital bedside, ambulatory surgery centers, birth centers, and clinic offices.
SurgiBox is now actively fulfilling global sales orders and ramping up operational readiness to support a rapidly growing sales pipeline. The company is bolstering its supply chain and expanding its network of distributors to ensure smooth delivery and outstanding customer satisfaction.
Backed by new strategic partnerships, SurgiBox is accelerating market penetration and expanding its global footprint. The company has simultaneously launched a fundraising campaign to ensure the resources and capital needed to meet rising demand.
