Neola’s CEO: “The certificate is a clear sign of strength”
Neola Medical’s product Neola, developed for continuously monitoring premature infants’ lungs, has been certified according to rigorous international standards. Thus, the company has passed another milestone ahead of the US FDA application for market approval.
– This demonstrates the efficiency of our structured product development process and underlines our focus on quality and patient safety, says CEO Hanna Sjöström
Neola Medical’s medical device Neola has been developed to detect complications in premature babies faster and more safely. The goal is twofold – firstly, that more neonatal children 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 decreased financial burden for the healthcare system.
Successful usability study
The big looming goal for Neola is to enter the largest market, USA. To succeed, they must first conduct a clinical study in the country. A previous independent study on 100 newborn babies from an Irish research team at the INFANT Centre at University College Cork has already shown that the product is safe to use and well tolerated on 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 easy and safe to use and confirmed the clinical benefits of pulmonary monitoring in neonatal intensive care – three important parameters for a potential market approval in the US.
International certificate for 50 countries secured
This week, Neola Medical announced that the product has now also passed the accredited test consultant FORCE Technology’s extensive and rigorous tests for the IEC 60601-1 and IEC 60601-1-2 standards. The tests resulted in the company obtaining a so-called IECEE CB scheme certificate certifying Neola’s safety and performance. The certificate is recognized in some 50 countries and, like the usability study, will form the basis for the US FDA application for market approval.
Comments from the CEO
Neola’s progress bodes well for a potential entry into the US market. How does the company view this? BioStock contacted CEO Hanna Sjöström for a comment.
Hanna, Neola has added several pieces of the puzzle towards an FDA approval in the United States in just a few months. How important is the certificate that you have now secured to get there?
– With the CB certificate in place, we have achieved a very significant milestone in line with our plan for future 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 NICU (Neonatal Intensive Care Unit) clinics.
How do you ensure that Neola continues to meet the stringent safety and performance requirements throughout the product lifecycle?
– We have broad expertise in the team that has developed a carefully planned product development strategy. We work with them to ensure that Neola meets high international standards and maintains high performance. Being named a Stanford Impact1 Fellow, we are one of the top medical device innovation companies in the world with the most promising medical device with the potential to improve neonatal care from day one in the clinic. We also receive invaluable regulatory support from world-leading experts in Stanford’s programme, which is also partly 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 offer the highest level of neonatal intensive care for newborns in the US. This provides us with a dedicated forum involving FDA paediatricians and regulatory experts for informal discussion of the company’s regulatory strategy and development and curriculum.
Beyond the certification, what other important milestones remain before you can apply for market approval with the FDA?
– After passing several important milestones, we are now entering the clinical validation phase of product development with intensified planning of the clinical study in premature babies in the US. This is our next major focus towards the goal of an FDA approval prior to market launch in the US.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
