Approvals

FDA Approves Zephyr Endobronchial Valve

The FDA granted approval for PulmonX’s Zephyr endobronchial valve for treating breathing difficulties in patients with severe emphysema.

The device is placed in the lung airways of patients using a flexible bronchoscope during a hospital procedure. The valves close during patient inhalation, keeping air from entering the damaged area of the lung and open during exhalation, releasing trapped air and relieving pressure.

TransMed’s Soft Tissue Biopsy Platform Receives 510(K) Clearance

The FDA cleared TransMed’s SpeedBird platform used for soft tissue biopsies.

The device is made up of a single element constructed from three hypodermic tubes with twin opposed cutter blades. It can be fully automated or manually operated and provides a pathway to transport multiple tissue samples by using a closed-circuit flush and vacuum mechanism that sends the samples into a removable chamber.

It is intended to address issues with current biopsy devices, such as sharp and potentially traumatic needle tips and needle gauge and tissue type restrictions.

Medtronic Gains Expanded Indication for Bone Cement

The FDA granted expanded 510(k) clearance for Medtronic’s Kyphon HV-R bone cement, designed to fixate pathological fractures of the sacral vertebral body.

The bone cement already has an indication for fixing pathological fractures of the sacral vertebral body or ala using sacroplasty or sacral vertebroplasty.

The bone cement’s expanded indication now allows it to treat fractures caused by osteoporosis, cancer or benign lesions by using a cementoplasty procedure.

LumiThera’s Dry AMD Treatment Device Gains CE Mark

LumiThera’s LT-300 device, used for treating dry advanced macular degeneration, has earned a CE Mark.

The device uses the company’s LT-300 light delivery system to treat patients who suffer from a loss of central vision.

The treatment incorporates low level light therapy, applying red and near-infrared light to improve and repair tissue that has experienced degeneration or injury.

Plum Medical’s Portable Medical Imaging Device Cleared by FDA

The FDA granted approval to Plum Medical Solutions’ second version of Med-Tab, a portable medical imaging workstation.

The tablet is used for medical image analysis and reading and is calibrated for the DICOM standard.

The device is designed for use in radiology practices, hospital radiology departments and other disciplines that rely on medical imaging for diagnosis and therapy.

Zetta’s MRI Software Algorithm Cleared by FDA

The FDA granted 510(k) clearance for Zetta’s MRI software algorithm used for image quality enhancement and image optimization of short scanning techniques.

Zoom works with all MRI models from major manufacturers and allows imaging staff to automatically process all MRI imaging techniques, such as short scans that are time sensitive.

The software uses the DICOM communications standard to receive and process data and automatically sends the enhanced images to picture archiving and communication systems.

The software can manage incoming data from multiple scanners in the case of aggressive workflow demands.

Shape Memory Medical Gains 510(k) Clearance

Shape Memory Medical’s Impede embolization plug gained 510(k) clearance from the FDA for use in obstructing the rate of blood flow in the peripheral vasculature.

The device, used for treating conditions that require blockage of the peripheral vasculature, is available in three sizes to treat vessels up to 10mm in diameter.

The plug features porous materials that can change from a catheter-deliverable shape to a larger, memorized shape.

Apollo Endosurgery Cleared for Endoscopic Suturing System

The FDA granted special 510(k) clearance for Apollo Endosurgery’s OverStitch Sx endoscopic suturing system used for advanced endoscopic surgery.

The special 510(k) clearance addresses an accessory added to the system to improve attachment to compatible endoscopes.