Sensus gets Chinese regulatory approval for keloid device

US-based Sensus Healthcare has received approval from the China Food and Drug Administration (CFDA) to commercialise its keloid prevention and treatment device, SRT-100. The tool is designed to deliver a precise and calibrated dose of superficial radiation therapy to ensure a skin deep and safe treatment for patients. The low-dose radiation is intended to destroy keloid-causing non-malignant tumour cells, basal cell carcinoma and squamous cell carcinoma without the use of anaesthesia, risk of infection, scarring or the need for reconstructive plastic surgery. Sensus intends to introduce SRT-100 into the country’s market in the fourth quarter of this year through its Chinese partner Chindex Medical, which is a division of Fosun Pharma International. The device will focus on prevention and treatment of keloids associated with Cesarean sections (C-sections). Sensus Healthcare CEO Joe Sardano said: “CFDA clearance of the SRT-100 for the treatment and prevention of keloids is an important milestone for ...

• Source: Medicaldevice-network
• 450
• July 28, 2017