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Tyber Medical’s PEEK ToeGrip Hammer Toe Implant Family Receives MDR Certification

September 10, 2024

BETHLEHEM, Pa., Sept. 10, 2024 /PRNewswire/ — Tyber Medical LLC, a leading orthopedic device manufacturer specializing in private label implants for the extremity, trauma, and spine markets, is proud to announce that its PEEK ToeGrip Hammer Toe implant family has received Medical Device Regulation (MDR) certification from TÜV Rheinland. This prestigious certification marks the first time a hammer toe implant has achieved both FDA 510(k) clearance and MDR certification, setting a new standard for orthopedic implants.

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AZmed Secures FDA 510(k) Clearance for Rayvolve in Pediatric Fracture Detection Through Study with SimonMed Imaging, Expanding Its AI-Powered Medical Imaging Solutions

September 3, 2024

PARIS, Sept. 3, 2024 /PRNewswire/ — European MedTech startup AZmed, recognized as a leading company in AI for medical imaging, today announced that its Rayvolve solution has received 510(k) clearance from the Food and Drug Administration (FDA) for detecting fractures on pediatric X-rays. This milestone comes two years after receiving FDA clearance for adult fracture detection, positioning Rayvolve as a top-performing solution for detecting fractures in adult and pediatric patients. The clearance was supported by an independent study conducted with SimonMed Imaging, one of the largest outpatient imaging providers in the U.S.

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