Renovis Gains FDA Clearance for Interbody Spinal Fusion System
Renovis won 510(k) clearance for its Tesera SA hyperlordotic anterior lumbar interbody spinal fusion system.
The porous, titanium implants feature a four-screw design and a locking cover plate to prevent the screws from backing out.
The implants are made using 3D printing, with a porous surface structure that enables in-growth and bone attachment to the implant.
Medtronic’s Automated Insulin System Receives CE Mark
Medtronic’s hybrid closed loop automated insulin system, which combines an automated insulin pump with a continuous glucose monitor, gained CE Mark approval.
The device uses a new sensor to achieve a fully closed loop system and it has a built-in algorithm to prevent glucose spikes and allow for better diabetes management.
The new sensor, which is 80 percent smaller than its predecessor, uses a battery that has been improved to last seven days instead
Hologic’s MRSA Assay Receives CE Mark in Europe
Hologic’s Panther Fusion MRSA assay received CE Mark approval in Europe.
The assay detects and differentiates between Staphylococcus aureus and methicillin-resistant Staphylococcus aureus DNA by analyzing nasal samples.
The assay is capable of identifying empty a broad range of strains.
Tenon Medical’s Joint Fusion System Cleared by FDA
The FDA granted 510(k) clearance for Tenon Medical’s Catamaran sacroiliac joint fixation system.
The system is indicated for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, common causes of pain in the legs, lower back and the sacroiliac joint.
The device allows surgeons to choose between using a navigated procedure or fluoroscopic imaging while the implant is designed to allow for bone graft materials to be loaded and delivered before and after placement.
Axonics’ Implantable Neurostimulator Receives CE Mark
Axonics was granted a CE Mark for its sacral neuromodulation external trial system, used in treating patients with urinary and bowel dysfunction.
The external trial system consists of a temporary, single-use stimulator that is connected to either a tined lead or peripheral nerve stimulator lead, depending on the trial method.
The trial system is an extension of the Axionics sacral neuromodulation system and is used to help identify patients responsive to sacral neuromodulation therapy before a permanent implant is installed.
ThermoFisher’s Allergy, AutoImmune Testing Platform Gets CE Mark
ThermoFisher’s Phadia 200, a benchtop instrument used to test for allergy and autoimmunity conditions, has received CE Mark approval.
The instrument, which quantifies clinically relevant antibodies in blood, is capable of performing up to 700 different ImmunoCAP and EliA tests. It can process 42 samples and produce up to 200 test results daily.
The device is meant to be used in smaller diagnostic facilities for the purposes of improving output and efficiency, and reduces the frequency of sending samples offsite for testing.
Oculocare’s Alleye App Cleared for Monitoring AMD
Oculocare’s Alleye, a mobile application was granted 510(k) clearance by the FDA for monitoring eyesight in age-related macular degeneration (AMD).
The app gives patients the ability to regularly test their eyesight and assess the progression of disease without the supervision of a doctor.
It is designed to detect and characterize visual distortion in patients with macular conditions such as AMD and diabetic retinopathy.
RedDress Receives Clearance for Wound Care Device
RedDress received 510(k) clearance for its wound care device, which allows health care providers to produce whole blood clots.
The device is intended to be used at point-of-care, using the patient’s own peripheral blood to clot wounds.
Under professional supervision, the blood clot produced by the system is topically applied to manage exuding cutaneous wound such as ulcers and mechanically or surgically-debrided wounds.
IsoRay’s GammaTile Cleared for Treating Recurrent Brain Neoplasms
IsoRay it received 510(k) clearance for its GammaTile therapy, a device that treats recurrent brain tumors.
The device uses proprietary Cesium-131 seeds within customizable collagen-based carriers to treat the tumors, delivering a fast-acting therapeutic dose near the tumor bed.