Pyrexar Medical In The News

Pyrexar receives final authorization to sell Thermal Therapy devices in Korea

Pyrexar’s line of hyperthermia-based cancer treatment products has received approval from the Korea Good Manufacturing Practice (KGMP).  Similar to ISO 13485 quality system standards, KGMP is required by the Korea Ministry of Food and Drug Safety (MFDS) and opens the door for shipment to, and use of, Pyrexar products in South Korea.

The MFDS, formerly known as the KFDA (Korea Food and Drug Administration), is a South Korea government agency responsible for promoting the public health by ensuring the safety and efficiency of foods, pharmaceuticals, medical devices and cosmetics as well as supporting the development of the food and pharmaceutical industries. In addition to their goal to offer people safe foods and drugs that perform as prescribed.

“We are looking forward to participating in the South Korea medical device marketplace,” says Mark Falkowski, CEO Pyrexar Medical.  “Korea ranks 11th in GDP and per capita healthcare expenditures are rising. We believe our products can be put to good work in this country”.

Pyrexar Medical is a pioneer and worldwide market leader in the development and manufacture of innovative and highly effective thermal therapy/hyperthermia treatment systems with established distribution and support networks around the world. PYREXAR HyperThermia (PYREXAR HT) treatments, proven in multiple clinical trials over the last 30 years, increase the effective dose of ionizing radiation in solid tumors up to 3X without increasing toxicity to healthy tissues.
To find out more about Pyrexar Medical products, visit our webpage  For information about purchasing our products in South Korea, contact