Japan’s PMDA Opens Training Center
Japan’s Pharmaceuticals and Medical Devices Agency launched the Asian training center for regulatory affairs April 1. Regulators and industry representatives will present objectives and expectations during a commemoration celebration on April 7 at the Imperial Hotel in Tokyo. Establishment of the center was announced in the PMDA’s International Strategic Plan 2015 on June 26, 2015, as part of a strategy to build regulatory capacity in partner countries ().
Anika Therapeutics Nabs CE Mark Approval
Bedford, Mass.-based Anika Therapeutics has received the CE mark for its combination viscosupplement Cingal for the treatment of osteoarthritis of the knee. In clinical trials, the device — which is administered by injection— demonstrated — superiority over placebo at 12 weeks and patients experienced improvement in stiffness and physical function at 26 weeks, the company says. Previously, Cingal was approved in Canada, and the company is pursuing a sign-off by the FDA.
TGA Schedules Postmarket Workshops
Due to popular demand, Australia’s Therapeutic Goods Administration has scheduled two additional workshops on postmarket roles for regulatory affairs representatives in medical device companies. One will be held June 23 in Melbourne and the other July 28 in Brisbane. Scheduled sessions include annual reporting requirements and postmarket reviews. For more information, visit www.tga.gov.au/medical-devices-how-stay-included.
Japan Approves Glaukos’ iStent
The Japanese Ministry of Health, Labor and Welfare has approved Glaukos’ iStent trabecular micro-bypass stent for use in combination with cataract surgery to reduce intraocular pressure in adults. The stent is approved in adults with moderate open-angle glaucoma who are currently on ocular hypotensive medication. Further, it’s the first ab interno micro-invasive glaucoma surgery device approved for use in Japan, according to the company. iStent garnered FDA approval in June 2012. In total, it is approved in 27 countries.
Russia Sees Counterfeit Crackdown in Dentistry
Russia’s Federal Service for Surveillance in Healthcare, or Roszdravnadzor, has teamed up with other authorities in that country to find counterfeit medical devices used in dentistry. The effort uncovered counterfeit drugs and devices that were sold in dental clinics across Russia. Roszdravnadzor says it will continue to work on quality control of medical devices used in dentistry.
MedX Wins Incubator License
MedX Ventures Group — an investment and management company with offices in the U.S., EU and Israel — has been selected to receive a license to run an incubator in Or Yehuda, Israel. The incubator is owned by Boston Scientific, Intellectual Ventures, Med-Accelerator and Tel Hashomer’s commercialization company and will invest in the medical device, combined medicine and digital health arenas. MedX’s portfolio companies are Microbot Medical and XACT Robotics. The incubator program is backed by the Israeli government.