Tag: clinical trial

US FDA seeks to “modernise” clinical trials with new draft guidance

The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design...
nevro senza

Nevro announces FDA approval of high-frequency SCS therapy for painful diabetic...

Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system to treat chronic pain associated with painful diabetic...
IDCT

Clinical evaluation of non-surgical degenerative disc disease treatment to begin in...

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved a Clinical Trial Notification (CTN) application for IDCT (DiscGenics), an allogenic injectable disc cell...

Zimmer Biomet Spine announces FDA approval of Mobi-C cervical disc labelling...

  Zimmer Biomet has announced that the US Food and Drug Administration (FDA) has approved an extension to the Mobi-C Cervical Disc labelling to include...
namilumab

Phase II proof-of-concept clinical study of Namilumab for ankylosing spondylitis initiated

Izana Bioscience, a biopharmaceutical company focused on translational medicine, has announced the initiation of a phase II proof-of-concept clinical study of namilumab in ankylosing...
IDE

Cerapedics announces first patients enrolled in IDE clinical trial of P-15L...

  The first patients have been enrolled in an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of the next-generation P-15L peptide...

First porous PEEK spinal implant clinical study validates its use in...

Porous polyetheretherketone (PEEK) technology (NuVasive) is a clinically viable alternative for improving osseointegration and fusion rates of interbody implants to treat degenerative cervical disc...

Pivotal clinical trial demonstrates superiority of anular closure compared to standard...

The use of a bone-anchored anular closure device following discectomy is superior to treating high-risk patients with discectomy alone, a two-year study recently published...