The agency granted its first approval order under the humanitarian device exemption in spinal pediatrics in the last 15 years.
The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.
The non-invasive trigeminal nerve stimulation system is intended for patients seven to 12 years old.
Developing medical devices in general is costly, but there is funding available for companies that are willing to create products specifically for pediatrics.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
A great idea is not the same as great execution.
Innovators will also receive guidance in the areas of prototyping, engineering, IP, testing, grant-writing and clinical trial design.
Early-stage companies are seeking cures for diseases from heart conditions to skin cancer.