Pyrexar Medical, Inc.

Pyrexar Medical, Inc. specializes in microwave hyperthermia systems, such as the BSD-500 and BSD-2000 models. These devices are designed to deliver controlled microwave energy for localized tissue heating, primarily used in oncology for thermal ablation or tumor therapy. The technology focuses on precise thermal treatment to target affected areas in medical procedures.

Pyrexar Medical, Inc. is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations, including classification under Class III or Unclassified categories. This means some models may require Premarket Approval (PMA) or be listed under the Unique Device Identifier (UDI) system, ensuring compliance with US medical device standards.

Pyrexar Medical, Inc.’s devices are included in the FDA’s Premarket Approval (PMA) registry and the Unique Device Identifier (UDI) listing system. These registries track authorised medical devices under US regulations, ensuring transparency and compliance for Class III and Unclassified hyperthermia systems like the BSD-500 and BSD-2000.

The FDA classifies Pyrexar Medical, Inc.’s hyperthermia systems as either Class III or Unclassified devices. Class III typically applies to high-risk medical devices requiring strict regulatory oversight, such as those used in life-supporting or life-sustaining applications. The classification determines the authorisation pathway—some models may require Premarket Approval (PMA), while others are listed under the UDI system to ensure safety and efficacy.