Approvals

NuVasive’s Surgical Automation Platform Cleared by FDA

The FDA granted 510(k) clearance for Pulse, NuVasive’s surgical automation platform, which combines 2D and 3D navigation and smart imaging capabilities.

Used for spinal surgery, the device includes multiple technologies with features that allow wifi and independent device access.

Pulse addresses visualization problems during surgery by using multiple high-resolution cameras to allow surgeons an uninterrupted line of sight.

CarboFix Spine Screw Systems Cleared by FDA

CarboFix’s CarboClear carbon fiber pedicle screw system was granted 510(k) clearance by the FDA for three different sized screws.

The three screw types, which come in diameters of 5.5, 6.5 and 7.5 mms and lengths of 30-45 and 35-55 mms, are marked by an ultrathin titanium shell to allow visualization with a fluoroscope.

The device can be used temporarily in patients with advanced stage thoracic and lumbar spine tumors who cannot undergo fusion.

FDA Clears Sekisui’s Diabetes Assay

The FDA granted 510(k) clearance for Sekisui Diagnostics’ Sekure Hemoglobin A1C (HbA1c) assay for diagnosing diabetes mellitus.

The assay eliminates manual preparation prior to testing. It is now available on the company’s SK 500 clinical chemistry system.

The HbA1c assay has also been cleared for identification of patients at risk for developing the disease and monitoring long-term blood glucose controls in individuals that have the disease.

FDA Approves Roche’s HPV Test for Cervical Cancer Screening

The FDA approved Roche’s cobas HPV test for first-line screening of cervical cancer in women 25 years and older.

The cobas HPV test is now approved for all cervical cancer screening indications included in professional society guidelines.

The test assists healthcare providers in identifying women at risk for cervical cancer by identifying the DNA of the HPV genotypes most responsible for causing cervical cancer, as well as high-risk genotypes.

TGA Approves Baxter’s Infusion System

Australia’s Therapeutic Goods Administration approved Baxter’s Evo IQ infusion pump system.

The infusion system comes with an advanced drug library and software that reduces dose errors to improve patient safety.

It also features technology that allows physicians to switch easily between gravity and pump applications without changing sets, which may reduce the chance of touch contamination.

Medtronic’s Spinal Cord Stimulator Approved in Canada

Health Canada approved Medtronic’s Intellis spinal cord stimulator for treating chronic pain.

Commonly used for treating pain caused by failed back syndrome, the device sends mild electrical signals to nerves in the epidural space.

Spinal cord stimulators are also used for treating complex regional pain syndrome, intractable angina, pain from nerve damage and visceral abdominal and perineal pain.

FDA Clears Modulated Imaging’s Clarifi Imaging System

The FDA granted 510(k) clearance to Modulated Imaging’s Clarifi imaging system, used for noninvasively assessing tissue function.

The device quantifies and displays hemoglobin concentration and its distribution and reveals individual biomarkers for physician use.

The imaging system measures oxygenation and hemoglobin levels in order to treat burns, foot ulcers, chronic wounds, peripheral vascular diseases and other conditions.

Hologic Gains Approval for Group B Strep Assay

The FDA granted approval for Hologic’s group B streptococcus (GBS) assay for its Panther Fusion system.

The approval comes after July’s GBS awareness month, an initiative to improve knowledge and prevention methods for GBS during pregnancy.

The nucleic acid amplification test is used to identify pregnant women that carry the bacterium, which can lead to life-threatening complications in their children.

Strata’s Tip Accessory for Excimer Laser Receives Clearance

The FDA granted 510(k) clearance to Strata Skin Sciences for its Multi-Micro Dose tip accessory, which is used with its Xtrac 308nm excimer laser.

The tip accessory is used in conjunction with the excimer laser, which is used to treat psoriasis. It can be used on areas that are difficult to treat and have not responded to other types of treatment.

The accessory is designed to filter narrow band UVB light to deliver the maximum dose for patients without causing blisters.

FDA Expands Indication for Savi Scout Reflector

Cianna Medical received 510(k) clearance to expand the indication for its Savi Scout reflector.

The expanded indication allows the Scout device — which is used for wireless breast tumor localization — to be used for localization of soft tissue, including axillary lymph nodes.

The reflector is used for breast tumor treatment procedures, such as targeted lymph node dissection, marking tissue before neoadjuvant chemotherapy and breast tumor localization.