FDA clears a Strykers Spine division 510(k) for its Tritanium TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion cage intended for use as ...
Yale University researchers say few drug DTC ads follow FDA regulation requirements and often are unreliable and misleading.
FDA clears a Panther Orthopedics 510(k) for the Puma System, an implantable flexible fixation device indicated for syndesmosis fixation, hallux valgus...
FDA says the number of medical device reports on Bayers Essure it received in 2017 was more than twice the number received in 2016.
Attorney Michelle Yeary says the 3rd Circuit Court of Appeals has ruled that multi-component medical devices should be evaluated for preemption compon...
FDA approves an Orthofix International PMA for its next-generation Physio Stim bone growth stimulator.
Five stakeholders recommend changes to an FDA draft guidance on good ANDA submissions.
Sagent Pharmaceuticals recalls 10 lots of methylprednisolone sodium succinate for injection (40mg, 125mg and 1g) due to the discovery of high out-of-s...