– This demonstrates the efficiency of our structured product development process and underlines our focus on quality and patient safety, says CEO Hanna Sjöström.
Neola Medicals medical device Neola. has been developed to detect complications in premature babies more quickly and reliably. The goal is twofold – firstly, that more neonatal babies will survive and be able to live without serious disabilities, and secondly, to facilitate the work in neonatal intensive care units. The bottom line is reduced suffering and a reduced financial burden on the healthcare system.
Successful usability study
The big looming goal for Neola is to enter the largest market, the United States. To succeed in this, a clinical study must first be conducted in the country. A previous independent study on 100 newborn babies by an Irish research team at the INFANT Center at University College Cork has already shown that the product is safe to use and well tolerated in premature babies.
In dialogue with the FDA, Neola Medical recently completed a successful usability study in Boston. In addition to the good formal results, the company received positive feedback from the 15 participating nurses who found Neola simple and confirmed the clinical benefit of lung monitoring in the neonatal intensive care unit – three important parameters for potential market approval in the US.
International certificate for 50 countries secured
This week, Neola Medical was able to announce that the product has now also passed the accredited testing house. FORCE Technologies extensive and rigorous testing for the standards IEC 60601-1 and IEC 60601-1-2. The tests resulted in the company now receiving an IECEE CB scheme certificate, which certifies Neola's safety and performance. The certificate is internationally recognized in some 50 countries and, like the usability study, will form the basis for the FDA application for market approval in the USA.
CEO comments
Neola's progress bodes well for a potential entry into the US market. How does the company itself view this? BioStock contacted the CEO Hanna Sjöström for a comment.
Hanna, in just a few months you have added several pieces of the puzzle towards FDA approval in the US. How important is the certificate you have now secured to getting there?
– With the CB certificate in place, we achieve a very significant milestone in line with our plan for upcoming market approval with the FDA and demonstrate the company's ability to meet comprehensive and stringent international medical device standards.
Can you explain in more detail what tests and requirements Neola has undergone?
– The certificate for IEC 60601-1 and IEC 60601-1-2 means that the product meets specific quality requirements and international standards for medical devices in healthcare, with particularly high requirements for safety, essential performance and electromagnetic compatibility. In practice, this means that Neola has been tested and verified to be safe for use according to the requirements that apply to its use in neonatal intensive care clinics.
How do you ensure that Neola continues to meet the strict requirements for safety and performance throughout the product's lifecycle?
– We have broad expertise in the team that has developed a carefully planned product development strategy that we work towards to ensure that Neola meets high international standards and maintains high performance. As we have been designated by Stanford as a Stanford Impact1 company as one of the leading medical technology innovation companies in the world with the most promising medical technology product with the potential to improve neonatal care from day one in the clinic, we also receive invaluable regulatory support from world-leading experts within Stanford's program, which is also partially funded by the FDA.
– The FDA’s full support and commitment to integrating the most advanced medical devices aims to improve care for children and provide the opportunity to provide the highest level of neonatal intensive care for newborns in the United States. This provides us with a dedicated forum with FDA pediatricians and regulatory experts for informal discussions about the company’s regulatory strategy and study plan.
In addition to certification, what other important milestones remain before you can apply for market approval with the FDA?
– With several important milestones met, we are now entering the clinical validation phase of product development with intensified planning of the clinical study in premature infants in the US. This is our next major focus towards the goal of FDA approval for market launch in the US.