Intronix Technologies Obtains FDA 510(k) Clearance for Myoguide™ System
Intronix wins US regulatory clearance for its Myoguide device with assistance from Emergo Group
A hand-held, battery-operated device, Myoguide functions by amplifying electrical activity generated by patients’ muscles and providing audio feedback to clinicians to more effectively locate areas of muscle activity and better select injection sites. The device can help in treatments such as pain management, movement disorder treatment and cosmetic procedures.
Intronix’s FDA 510(k) application process was supported by Emergo Group, a medical device regulatory consulting firm headquartered in Austin, Texas. Dr. Evan Friedman, President at Intronix, explains the process of selecting third-party assistance to navigate the 510(k) process.
“As this was our first FDA 510(k), we were looking for a company that had knowledge dealing with the FDA and could also serve as our regulatory representative in Europe and the US,” says Friedman. “Emergo Group was a great fit for us because we plan to expand into other international markets in the future and they have offices in all the markets we plan to enter.”
Once Intronix partnered with Emergo Group, the consulting firm prepared all 510(k) application materials based on the manufacturer’
“For companies such as Intronix going through the FDA 510(k) process for the first time, the process can often prove more complex and challenging than in other markets,” says Richard Vincins, Vice President of Quality Assurance Consulting at Emergo Group. “By leveraging our regulatory expertise to win FDA clearance, Intronix can focus on product development and marketing in the US.”
Intronix has been manufacturing medical devices since 1984 and specializes in electrophysiological amplifiers for use in the study of the electrical activity of muscles. More information at intronix.com
About Emergo Group
Emergo Group is a global medical device regulatory consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting.
Intronix Technologies Corporation
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