Approvals

Zebra Medical Vision Cleared For Brain Bleed Algorithm

The FDA granted 510(k) clearance to Zebra Medical Vision’s AI imaging algorithm for intracranial hemorrhaging detection.

The algorithm will be included in the company’s Deep Learning Imaging Analytics platform, which can analyze CT data for signs of fatty liver, emphysema, low bone density and other conditions.

The algorithm is intended to be used for point of care detection and worklist prioritization, allowing physicians to more accurately and speedily detect brain bleeds.

FDA Clears Cutting Edge Spine’s Cervical Spine Interbody Implant

Cutting Edge Spine announced that the FDA granted 510(k) clearance for its EVOL ha-C cervical interbody system.

The company also plans to release anterior lumbar interbody fusion, oblique lateral interbody fusion and direct lateral interbody fusion systems later in the year.

The system is made of PEEK-OPTIMA HA enhanced material that is used in the creation of implants. Implants made from the material have shown to cause early onset bone formation and bony apposition to the implant during fusion.

Angiodroid Earns CE Mark for Intra-Aortic Balloon Pump

Angiodroid received a CE Mark for its Angiopulse, an intra-aortic balloon pump (IABP) device that utilizes pressure regulation.

The device is designed specifically for weaning situations and is suited for all types of patients in need of IABP therapy.

The device offers the user touch screen, wireless interface with remote control, therapy monitoring and interactive user guide capabilities.

EchoNous Receives Approval for Catheter Placement Tool

EchoNous was given 510(k) approval for its Vein device, a tool that uses ultrasound to assist in the placement of peripheral IV catheters.

The device is intended to be used by nurses to improve their placement of catheters and can be used for both children and adults.

The tool, which uses a two-button control, visualizes superficial and deep veins and gives clear images at depths from 1 to 5 centimeters.

French Company Receives CE Mark for Laparoscopic Applicator

Surgical hemostasis specialist Biom’Up received the CE Mark for its laparoscopic applicator, extending its indication.

The extended indication allows surgeons to use HemoBlast Bellows hemostatic powder for both open and laparoscopic surgery.

The device’s additional indication allows the device to be used for hemostasis when controlling bleeding in classical procedures is impractical, ineffective or impossible during laparoscopic procedures for vascular, abdominal, urology, gynecology, neck and head surgery.

Medtronic’s Less-Invasive Implant Approach for HeartWare Device Gains Approval

The FDA approved Medtronic’s less-invasive implant approach for its HeartWare left ventricular assist device used to treat patients with advanced heart failure.

The device helps increase blood flow throughout the body by helping the heart to pump. It is typically implanted via a surgical procedure, median sternotomy, in which a vertical incision is made down the chest and the breastbone is divided.

The new approval allows implantation via thoracotomy, a procedure that makes a small incision between the patient’s ribs on the left side of the chest.

SuperSonic Imagine’s Ultrasound System Receives Approval

Supersonic Imagine’s new ultrasound system, the Aixplorer Mach 30, received 510(k) clearance and the CE Mark.

The device offers enhanced imaging modes developed by the company, as well as a functional design and touchpad designed to simplify use.

The Mach 30 uses an elastography solution that allows users to conduct real-time 2D and 3D evaluation and visualization of tissue stiffness.

FDA Approves Stryker’s Flow Diverter for Treating Brain Aneurysms

Stryker received FDA approval for its Surpass Streamline flow diverter, used in treating certain types of brain aneurysm.

The Kalamazoo, Michigan based company’s device treats unruptured large and giant wide-neck aneurysms. The device is placed in the patient’s artery to divert blood flow.

The unruptured aneurysms are harder to treat because of their location and the surrounding anatomy.

Medtronic Gains Expanded FDA Nod for Pacing Leads

The FDA granted expanded labeling for Medtronic’s SelectSecure magnetic resonance imaging SureScan model 3830 cardiac leads for pacing of the muscle fibers that conduct the electrical impulses that regulate heartbeat.

The bipolar, steroid-eluting leads attach to a single or dual chamber pacemaker and now have approval for sensing and pacing in the atrium or right ventricle.