Clinical Innovations Announces FDA Clearance of Koala® Toco, an Advanced Technology Tocodynamometer

Salt Lake City, UT, October 14, 2014 – Clinical Innovations, LLC (CI) announced today the FDA clearance of Koala Toco, the first and only tocodynamometer to utilize air-charged technology to accurately measure uterine contractions. Koala Toco provides enhanced signal acquisition, easier-to- visualize tracings, and a better overall monitoring experience.
Peer-reviewed publications have highlighted the inherent lack of accuracy and limited prognostic value of traditional tocodynamometers.1 Koala Toco addresses these limitations through its advanced signal amplification technology, which is designed to improve performance, particularly in traditionally difficult-to-monitor patients such as those with high Body Mass Index (BMI).
Research has also highlighted the importance of infection control. According to the CDC, “on any given day, about 1 in 25 hospital patients has at least one healthcare-associated infection.”2, 3 In order to eliminate this risk, Koala Toco was designed to be disposable, making it more convenient and an effective tool in infection control.
“I’ve already noticed the difference Koala Toco has made. It works better on our difficult patients and is more comfortable for our moms. It’s also convenient to have new, clean tocos readily available,” said Mic Zywiec, RN, Nurse Manager, Valley View Hospital, Glenwood Springs, Colorado.
“Clinical Innovations is committed to developing and commercializing innovative technologies to solve challenges in obstetrics. Koala Toco is a simple and yet important innovation for clinicians and the thousands of pregnant women monitored daily. We are proud to make it easier for healthcare providers to help their patients deliver healthy babies,” said Jeff Bradford, Vice President Global Marketing, Clinical Innovations.
About Clinical Innovations
Clinical Innovations is the largest healthcare manufacturer exclusively focused on labor and delivery. Already a market leader in several categories with products such as the Koala®Intrauterine Pressure Catheter and Kiwi® Vacuum-Assisted Delivery System, Clinical Innovations is expanding its global presence while directly researching and developing state-of-the-art technologies and innovative medical devices that fulfill its mission of improving the lives of mothers and their babies throughout the world. Clinical Innovations is a Pritzker Group company. To learn more, visit www.clinicalinnovations.com.Reference:
1. Euliano TY1, Nguyen MT, Darmanjian S, et al. Monitoring uterine activity during labor: a comparison of 3 methods. Am J Obstet Gynecol. 2013;208(1):66.e1-6.
2. Healthcare-associated Infections (HAIs): HAI Prevalence Survey. Centers for Disease Control and Prevention Website. http://www.cdc.gov/HAI/surveillance/index.html. Updated: September 15, 2014. Accessed October 8, 2014.
3. Magill SS, Edwards JR, Bamberg W, et al. Multistate Point-Prevalence Survey of Health Care–Associated Infections. N Engl J Med. 2014;370:1198-208. 
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