medical magnesium announced that FDA has granted the company Breakthrough Device status for their orthopedic and trauma care plate system.
“The Breakthrough Device designation for our bioabsorbable orthopedic plates recognizes our ability to address one of the biggest unmet clinical needs in orthopedic surgery and traumatology,” said Kilian Reuss, CEO and co-founder of medical magnesium. Routinely performed surgical removal of conventional implants is a burden for patients, especially in pediatric surgery. The bioabsorbable plate system is designed to eliminate this burden and reduce total costs of care significantly.
The mm.X plate system is currently under development and has shown potential in in vitro and in vivo tests.
“The breakthrough device designation allows us to regularly synchronize our development process with FDA and to clearly meet the patients’ and physicians’ requirements for safe and well-performing medical devices early on. The ongoing collection of promising clinical data on other products of the mm.X family currently marketed in Europe further enriches the exchange with FDA greatly,” said Dr. Michael Gertig, VP Regulatory & Clinical Affairs.
medical magnesium announced that FDA has granted the company Breakthrough Device status for their orthopedic and trauma care plate system.
"The Breakthrough Device designation for our bioabsorbable orthopedic plates recognizes our ability to address one of the biggest unmet clinical needs in orthopedic surgery and traumatology," said Kilian...
medical magnesium announced that FDA has granted the company Breakthrough Device status for their orthopedic and trauma care plate system.
“The Breakthrough Device designation for our bioabsorbable orthopedic plates recognizes our ability to address one of the biggest unmet clinical needs in orthopedic surgery and traumatology,” said Kilian Reuss, CEO and co-founder of medical magnesium. Routinely performed surgical removal of conventional implants is a burden for patients, especially in pediatric surgery. The bioabsorbable plate system is designed to eliminate this burden and reduce total costs of care significantly.
The mm.X plate system is currently under development and has shown potential in in vitro and in vivo tests.
“The breakthrough device designation allows us to regularly synchronize our development process with FDA and to clearly meet the patients’ and physicians’ requirements for safe and well-performing medical devices early on. The ongoing collection of promising clinical data on other products of the mm.X family currently marketed in Europe further enriches the exchange with FDA greatly,” said Dr. Michael Gertig, VP Regulatory & Clinical Affairs.
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