Press communication
Lund, Sweden, June 4, 2024
This is a translation of the Swedish press release published 2024-06-04
Neola Medical AB (publ) announced today that Neola®, the company’s medical device for continuous monitoring of the lungs of preterm born infants, has successfully passed the comprehensive and stringent testing against IEC 60601-1 and IEC 60601-1-2 standards. This has resulted in the issuance of an IECEE CB Scheme certificate, which is recognized proof of Neola®’s safety and essential performance, issued by the accredited testing body FORCE Technology. The certificate is internationally recognized in about 50 countries and will form the basis for meeting the FDA’s regulatory requirements.
Neola® has obtained a CB certificate, signifying that the product has undergone a rigorous and comprehensive testing and evaluation process at an accredited and independent IECEE testing house, FORCE Technology. The certification for IEC 60601-1 and IEC 60601-1-2 indicates that the product meets specific quality requirements and international standards for medical devices in healthcare, with particularly high demands on safety, essential performance, and electromagnetic compatibility. In practical terms, this means that Neola® has been tested and verified to be safe for use according to the requirements for its application in neonatal intensive care units. This is a crucial piece that the company has secured in preparation for the market approval of Neola® in the USA.
“The acquisition of the CB certificate for Neola® is a testament to the effectiveness of our structured product development process, as it indicates that the product meets the IEC 60601-1 family of medical device standards and our risk management process according to ISO 14971. Furthermore, FORCE has reviewed our product development to ensure it adheres to standards for usability evaluation and software development. That our medical device, Neola®, has met these rigorous requirements underscores our commitment to quality and patient safety.”, says CTO Sara Bergsten.
“We are achieving a highly significant milestone in line with our plan for the upcoming market launch in the USA. The CB certificate demonstrates the company’s ability to meet extensive and stringent international medical device standards and means that we have a crucial component in place for the forthcoming market approval by the U.S. Food and Drug Administration (FDA).”, says CEO Hanna Sjöström.
For further information, contact:
Hanna Sjöström, CEO Neola Medical, phone: +46 (0)760-10 71 16, e-mail: hanna.sjostrom@neolamedical.com
Neola Medical AB (publ) develops medical technology device for continuous monitoring of preterm born infants’ lungs. Immediate detection of complications provides the possibility of early treatment and improved health care. The patented technology is based on a spectroscopic method developed at Lund University in Sweden. The company was founded in 2016 and is listed on NASDAQ First North Growth Market (ticker: NEOLA). Read more at www.neolamedical.com. The company’s Certified Adviser is FNCA Sweden AB.