Sicel technologies has won FDA approval for its “OneDose” wireless sensor.
Sicel said it plans to launch the product in July at a national physicists meeting.
The company describes OneDose as an “innovative, disposable, surface dosimeter”. It is designed to meet physicians’ demands for immediate, accurate and economic method of tracking patient reaction to treatments, such as radiation. Each device has built-in memory.
“This is a defining moment in Sicel’s short history. To bring a medical device from feasibility to practice in a demanding financial and regulated market is a true achievement,” said Michael Riddle, president and COO of Sicel, in a statement. “This is Sicel’s first cleared product and one on which we hope to build the foundation for our future growth. The company is optimistic about the product’s potential, is excited about the launch and looking forward to shipping our first orders.”
The devices will be distributed by MED-TEC, which is based in Iowa. The company focuses on design, development and distribution of technology related to radiation oncology care.
Sicel, which was founded in 1999, is developing a series of miniaturized, implantable sensors with an emphasis on oncology. Dr. Charles Scarantino, an oncologist at Triangle Radiation Oncology Services practicing in the Rex Healthcare Cancer Center, is the company’s founder.