FDA approval for RayPilot HypoCath

Micropos Medical has been approved by the FDA for its 510k application for the sale and marketing of RayPilot with HypoCath in the United States.

The company’s CEO, Thomas Lindström, says that – We are incredibly proud, happy, and grateful for this approval. The United States is the largest market for radiation therapy with over 200,000 new prostate cancer cases per year.

The American reimbursement system is gradually changing from having previously reimbursed the number of times a patient is treated with radiation to clearly reward fewer treatments, i.e., hypofractionation. This means that we have a great opportunity to market RayPilot with the HypoCath in several new markets.

Our system adds accuracy and precision with minimal side effects. We will now continue the work of shaping our global marketing strategy and establishing more local key positions, Thomas continues.

The work of defining ways into the American market has begun.