Tag: IDE
TOPS facet joint replacement demonstrates significant improvements versus fusion in IDE...
Premia Spine has announced the publication of two-year outcomes from the TOPS facet joint replacement system’s clinical trial in the Journal of Neurosurgery Spine, which...
Gimer Medical granted IDE approval for spinal cord stimulation system
Gimer Medical today announced that the company’s spinal cord stimulation (SCS) system was granted conditional investigational device exemption (IDE) approval by US Food and...
3Spine granted investigational device exemption approval
3Spine has announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for a US pivotal clinical trial for their MOTUS spinal...
ReVivo Medical announces first ever in-human use of its cervical fusion...
ReVivo Medical has announced that Darryl DiRisio (Albany, USA) has successfully completed the first two surgical procedures using the company’s new design of anterior...
3Spine raises US$33 million in Series C funding round
3Spine has raised US$33 million in an oversubscribed Series C private offering, the proceeds of which will be used to fund a Phase 2...
Seven-year IDE trial results show “prolonged and significant improvements” of activL...
Aesculap Implant Systems has announced the publication of seven-year results from a randomised controlled investigational device exemption (IDE) trial for lumbar artificial discs in...
ISASS 2021: Positive results out to four years reported for M6-C...
Orthofix Medical has announced preliminary three- and four-year functional outcomes from the M6-C artificial cervical disc single-level investigational device exemption (IDE) study which has shown that the...
Cerapedics granted breakthrough device designation for P-15L bone graft
Cerapedics has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its investigational P-15L bone...
Cerapedics receives FDA approval to initiate IDE study of P-15L bone...
Cerapedics, a privately-held orthobiologics company, has announced the company received approval from the US Food and Drug Administration (FDA) to initiate an investigational device...
US FDA approves IDE study for Premia Spine’s Tops system
Premia Spine has secured US Food and Drug Administration approval for its pivotal study of the new Tops system.
“We are excited about the opportunity to...