Icotec’s CMORE CT System Receives FDA Clearance for Minimally Invasive and Open Spinal Procedures

The FDA has cleared icotec’s CMORE CT System for use in both minimally invasive and open posterior cervicothoracic spine procedures.

The clearance expands the company’s BlackArmor Engineered Carbon/ polyether ether ketone (PEEK) technology portfolio, offering new surgical options for patients requiring spinal stabilization due to tumors, infections or complex degenerative conditions.

Spinal disorders are a rising burden, particularly among older adults. Conditions such as degenerative disc disease, spinal stenosis and metastatic spine tumors often require surgical intervention to stabilize the spine and protect neural structures.

While conventional metallic implants are standard, they can create imaging artifacts that interfere with postoperative monitoring and radiotherapy planning.

The CMORE CT System is fully radiolucent, meaning its materials do not block or distort medical imaging.

The system includes a comprehensive range of polyaxial screws, straight and precontoured rods and connectors engineered for posterior fixation in the upper spine.

In posterior cervicothoracic procedures, screws, rods and connectors are typically used to stabilize weakened vertebrae and maintain alignment during healing and follow-up therapy.

Made from icotec’s BlackArmor composite, a material combining continuous carbon fibers with PEEK, the implants provide high strength with artifact-free imaging in CT, MRI and X-ray.

This radiolucency is particularly beneficial in oncology, where clearer visualization guides radiation therapy and local tumor progression-monitoring.

The FDA clearance of the CMORE CT System follows icotec’s existing approvals for BlackArmor implants across other spinal regions, extending its application to the posterior cervicothoracic segment.

icotec plans to commercially launch the CMORE CT System in the US following the clearance. The company’s products, which have received both FDA and CE Mark certifications, are already used at multiple international spine surgery centers.

Advancements in Spinal Care This Year

This year brought several advancements in spine surgery, spanning imaging, materials science, minimally invasive techniques and data-driven care.

In July 2025, Fziomed received FDA De Novo classification for its Oxiplex gel, becoming the first intraoperative gel authorized to reduce postoperative leg pain and neurological symptoms after lumbar spine surgery. It forms a temporary tissue barrier during closure to prevent adhesions and aid postoperative recovery.

In August, SpinaFX Medical’s Triojection earned FDA Breakthrough Device designation for treating contained lumbar disc herniations. The image-guided system uses a proprietary oxygen-ozone delivery method to decompress discs and relieve nerve pressure. This offers a less invasive, outpatient alternative to conventional surgery.

Proprio and the Harms Study Group announced a partnership linking intraoperative data from the Paradigm AI visualization platform with outcomes registry information. The collaboration will automate surgical data collection and strengthen clinical evidence for AI-assisted spine surgery, especially in pediatric and deformity cases.

Carlsmed, developer of aprevo AI-enabled personalized implants, completed its Nasdaq IPO and reported 98% year-over-year revenue growth. The company plans to launch its cervical spine platform in early 2026.

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