SurgiBox Inc. announced CE Marking for its Smart Control Module 001-SCM-0000 and its Battery Pack BP-04002M.
SurgiBox has obtained Humanitarian Use Exemption for the use of the SurgiField System in Ukraine. The Exemption stated that the Authorizing Command is “confident that the SurgiField Kit would help protect our patients from the surrounding environment…and our healthcare providers from patient bodily fluids, truly providing safe surgery any time, any place.”
SurgiBox was founded in 2017 by doctors and entrepreneurs dedicated to improving access to safe surgical care and is an ISO 13485:2016-certified quality management system company.
RELATED: Zimmer Biomet obtains FDA 510(k) clearance for Persona OsseoTi Keel Tibia
“We have had long standing discussions and partnerships with healthcare providers as well as entities in Europe and in Ukraine,” said Sashidhar Jonnalagedda, SurgiBox Co-Founder and Forbes 30u30 Europe. “We are delighted these updates allow us to start to deliver this eagerly-awaited technology to support safe surgery at the point of need.”
The SurgiField System provides an ultraportable, battery-powered sterile environment that protects patients from particulates such as dust, debris and insects and protects healthcare providers from exposure to the patient’s bodily fluids, facilitating safe surgery. Each kit includes:
– Disposable, sterile, inflatable drapes known as SurgiBubbles™ that isolate the surgical site with a physical barrier and are accessed via armports, lineports, and a material port;
– A Smart Control Module that dynamically controls the pressure inside the SurgiBubble and delivers air through High Efficiency Particulate Air (HEPA) filters;
– The Battery Pack BP-04002M, a 14.4V USB-C battery with high-energy density and military-grade safety mechanisms; and
– Popup Frames that provide support to the SurgiBubbles.
Given heavy demand from hospitals and healthcare entities across Ukraine as well as other regions, SurgiBox Inc. is seeking strategic partners to accelerate scale-up.
To learn more, visit www.surgibox.com
Partners & Investors: partners@surgibox.com;
Business Inquiries: hello@surgibox.com.
SOURCE SurgiBox Inc
Are you Hiring?