The firm will submit a 510(k) later this month for its Ekso GT robotic skeleton, currently being marketed as a class I exempt device, based on feedback from FDA that robotic exoskeleton devices need to meet class II requirements.
Ekso Bionics Holdings Inc. can no longer rely on class I exempt status for its Ekso GT robotic exoskeleton. The company said Dec. 2 it plans to submit a 510(k) application later this month in response to FDA feedback.
Ekso GT is designed to help individuals with lower extremity weaknesses to stand up and walk. Ekso Bionics has been...
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
