Approvals

Xcision Medical Breast Cancer Device Scores FDA Clearance

Maryland-based Xcision Medical Systems achieved FDA 510(k) clearance for its noninvasive stereotactic radiation therapy system indicated for breast cancer treatment.

The GammaPod system features thousands of focused radiation beams and a vacuum-assisted cup for immobilizing the breast during a treatment procedure to preserve healthy tissue around the tumor.

Masimo Sensors for Oxygen Reserve Index Monitoring Score CE Mark

Masimo, a Swiss manufacturer of noninvasive monitoring technologies, received a CE Mark for its RD rainbow Lite SET sensors.

The sensors are intended to enable clinicians to noninvasively monitor the company’s Oxygen Reserve Index as well as its RPVi — a multi-wavelength version of the Pleth Variability Index.

The lightweight sensors have a flat, soft cable with smooth edges, so that they lie comfortably on a patient’s hand or foot.

FDA Expands Evoke Neuroscience System Use Indications

Evoke Neuroscience achieved 510(k) marketing clearance to expand the indications for use on its eVox System.

The new indications are electroencephalography and event-related potentials to aid in clinical diagnoses.

The device enables physicians to assess patients’ memory loss using the biomarkers it acquires.

Bausch + Lomb Achieves FDA Clearance for Crystalsert Injector

The FDA issued 510(k) marketing clearance for the Bausch + Lomb Cystalsert 2.6 injector.

The first-of-its-kind FDA-cleared injector can be used across the company’s suite of intraocular lenses.

The CI-26 allows for easy wound entry and helps prevent tissue snagging via an incision as small as 2.6 mm, the company said.

Mevion Secures FDA Clearance for Proton Therapy System

Mevion Medical Systems achieved FDA clearance for its MEVION S250i Proton Therapy System.

The system is designed to deliver radiation treatments using the company’s HYPERSCAN pencil beam scanning technology.

The technology uses energy layer switching and automated systems to deliver pencil point radiation treatments.

FDA Approves MRI-Conditional Labeling on Two Abbott Defibrillators

The FDA approved Abbott’s MRI-conditional labeling for two of its defibrillator devices.

The new labeling on the Quadra Assura MP cardiac resynchronization therapy defibrillator, and its Fortify Assura implantable cardioverter defibrillator will aid in clinical assessments.

The ICDs are intended for restoring normal heart rhythms, whereas CRT-D implant devices are designed to assist the lower chambers of hearts and improve blood flow throughout the bodies of patients with progressive congestive heart failure.

Hologic Gets CE Mark for Tissue Removal Treatment Device

American devicemaker Hologic received a CE Mark for its MyoSure MANUAL device.

The device features an integrated vacuum and a see-through tissue trap to enable clinicians to visually confirm the tissue being removed.

It is intended to “simplify tissue removal procedures regardless of setting,” the company said.

Canada Approves DermTech Pigmented Lesions Assay

California-based manufacturer of molecular dermatology DermTech secured approval to market its Pigmented Lesions Assay and its biopsy kit for detecting melanoma in Canada.

DermTech Canada will market and sell the assay in the country, and biopsy samples will be processed at the company’s central laboratory in La Jolla.

The assay is designed to analyze skin biopsy samples through a noninvasive adhesive patch.

FDA Clears Cerebrotech Neurological Spectroscopy Device

The FDA cleared Cerebrotech Medical Systems’ Cerebrotech Visor, a bioimpedance spectroscopy device designed to aid clinicians in assessing cerebral fluid volumes.

The clearance includes a broad indication for use in assessing fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment.

Nevro Wins FDA Nod for Spinal Cord Stimulation System

Nevro has received FDA approval for its Senza II spinal cord stimulation system.

The system delivers the company’s proprietary HF10 therapy, which provides the spinal cord with electrical pulses to treat pain by interfering with nerve impulses. The company has been battling in federal court against Boston Scientific over patent infringement allegations involving its SCS therapy.

Zimmer Biomet Scores FDA Clearance for Shoulder Treatment System

Devicemaker Zimmer Biomet received FDA clearance for its Sidus stem-free shoulder system.

The shoulder arthroplasty device is intended for anatomical restoration and bone preservation.

The company initiated a Class I recall in early 2017 of certain reverse shoulder system models due to a high fracture rate.