Two focused ultrasound manufacturers recently announced important regulatory milestones in the Asian market.
In China, Profound Medical has gained Food and Drug Administration approval to use Sonalleve® for the treatment of uterine fibroids. “Obtaining CFDA approval for Sonalleve marks a major milestone for our company and provides important additional validation of this powerful, patient-friendly new approach to treating uterine fibroids,” said Arun Menawat, CEO, in their press release. He added, “Our distribution partner, Philips, enjoys a strong brand position in China, having installed MR imaging systems in many of the country’s largest hospitals…”
See Profound Medical’s Press Release >
In Japan, Insightec is now under pre-market approval from the Pharmaceutical and Medical Devices Agency to use Exablate Neuro to treat mobility, rigidity, or dyskinesia in patients with Parkinson’s disease. Insightec’s CEO and Chairman of the Board, Maurice R. Ferré, MD, said that Exablate is already approved to treat the symptoms of essential tremor; however, “Insightec is committed to supporting research that extends the applications and potential of focused ultrasound, to improve the lives of people living with Parkinson’s disease with a much less invasive approach than conventional surgery.”
See Insightec’s Press Release >