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 ...
Samsung Electronics’ healthcare unit Samsung NeuroLogica has launched a new mobile, portable full-body computed tomography (CT) scanner, BodyTom Elite.
The US Food and Drug Administration has given a tentative green light to Merck & Co’s follow-on biologic basal insulin Lusduna Nexvue.
It is a common problem that concerned us. As a global pharmaceuticals and medical devices B2B online platform, Ddu invited Sherlock Chen, a senior biotech practitioner, to talk about how to develop the Indonesian market.
The USFDA said that it has achieved a year early the target set for 2017, to take action on 90% of the applications pending prior to the start of the Generic Drug User Fee Amendment Act (GDUFA) of 2012.
Merck and Pfizer have announced a second accelerated approval in the US for Bavencio in less than two months, in this instance for certain patients with metastatic urothelial carcinoma.
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