Hyperthermia Blog

News and Opinions About Our Industry

Great news! We are excited to share that our CE mark for Pyrexar Medical's product line of RF Hyperthermia Systems, including the BSD-500 Superficial/Interstitial Hyperthermia System, the BSD-2000, BSD-2000 3D and BSD-2000 3D/MR Deep Regional Hyperthermia System, has been renewed.

Although this may not come as a surprise to some, we wanted to highlight that the process of receiving this certification has become much more rigorous under the new EU MDR (European Union Medical Device Regulation 2017/745) framework. This was necessary to ensure a more robust, transparent, sustainable, and predictable regulatory framework and improve the overall level of health and safety of medical devices, while still supporting innovation in the industry.

We understand that this has resulted in many medical device manufacturers withdrawing products from the European Union, but at Pyrexar Medical, we believe that the benefits of hyperthermia are important for patients worldwide. We are committed to continuing to bring these benefits to the European Union and all parts of the world, and the rigorous process of receiving the CE marking is an important step in that direction.

Although the process was expensive and time-consuming, it was well worth it, and we are excited to continue to innovate and improve healthcare through our hyperthermia systems. Thank you for your support and trust in Pyrexar Medical.