CLS quality processes received good marks by American authority FDA

Clinical Laserthermia Systems (CLS) (publ) received good marks from the American authority Food and Drug Administration (FDA) as a review took place recently at CLS’ office in Sweden. Since CLS, starting last year, is marketing and selling the FDA cleared TRANBERG®|Thermal Therapy System on the U.S. market, the authority recently announced that they intended to visit the company to carry out a routine review. The purpose of the review is to ensure that CLS acts in line with the regulations and processes that an FDA clearance requires. The company received good marks and the FDA representative was very pleased by the knowledge and the competence that CLS showed during the four days that the review went on. A final report from FDA, a so called Final Establishment Inspection Report, is expected to be ready in a few months.    

- We are very proud of the result. This was the first time CLS was reviewed by FDA and the fact that it went so well sets an excellent foundation for future work, said Marie Gary, Director of Quality Assurance and Regulatory Affairs at CLS. The most common result in a review is the it generates a list of issues that the company has to solve within a certain timeframe in order to keep its FDA clearance. But at CLS there are no such issues I am very pleased to say, concluded Marie Grey.

Read more about FDA and approval of medtech products.

This press release has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.

Lars-Erik Eriksson, CEO, Clinical Laserthermia Systems AB (publ)
Tel: +46 – (0)702 – 90 33 00   E-mail: lee@clinicallaser.se

Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG®|Thermal Therapy System and specially designed sterile disposable products for safe, gentle and effective treatment of cancerous tumors. The products are marketed for image-guided laser ablation and for treatment with immunostimulating interstitial laser thermotherapy, imILT®. The company, which is headquartered in Lund Sweden and have subsidiaries in Berlin, Germany and Boston, MA,USA, is listed Nasdaq First North under the ticker CLS B. Certified Adviser is Västra Hamnen Corporate Finance. Further information is available on the company’s website: www.clinicallaser.se