WaveForm Gains CE Mark for Glucose Monitor
Wilsonville, Oregon devicemaker WaveForm announced that it received the CE Mark for its Cascade continuous glucose monitoring system, a device that displays its readings on a mobile app.
Using a disposable sensor that patients can wear for up to two weeks, the device sends measured glucose data to its accompanying mobile app via a Bluetooth transmitter every minute, with no additional receiver device necessary.
The monitor can be used for making diabetes treatment decisions for pregnant women, patients requiring dialysis and children aged two years and older.
DiFusion’s New Biomaterial-Using Spinal Implant Gains FDA Clearance
The FDA has handed 510(k) clearance to DiFusion for its Xiphos-ZF spinal implant, the first device of its kind to use the new biomaterial Zfuze.
The biomaterial’s surface is negative charged, microporous, and hydrophilic rather than hydrophobic, allowing it to support bony ingrowth while keeping the mechanical properties and imaging capabilities of traditional PEEK (polyetheretherketone) implants.
Zfuze can be injection molded, 3D printed or machined, and surface treatments such as laser etching and nano-surfacing can be performed on the material, DiFusion said.
Focal Healthcare’s Prostate Fusion Biopsy Solution Gains CE Mark
Focal Healthcare has received the CE Mark for its Fusion Bx 2.0, a semi-robotic prostate fusion biopsy solution that enables urologists to perform targeted prostate biopsies.
The system uses a simple interface and comes with a semi-robotic arm used to maintain probe steadiness during biopsies. It also displays a 3D model for prostate and MRI target visualization in real-time.
The Fusion Bx 2.0 features automatic motion compensation to account for patient movement, maintaining imaging and allowing procedures to continue uninterrupted.
FDA Clears Okami’s Vascular Occlusion System
The FDA granted Okami Medical 510(k) clearance for its Lobo vascular occlusion system, a device used in the occlusion of peripheral blood vessels.
The low-profile braided occluder is a minimally invasive device for rapid and focal occlusion of a wide range of arterial targets.
The system is compatible with microcatheters, allowing it to navigate the peripheral vasculature. It self-expands upon deployment and can conform to multiple targets, including curved vessels.
Tractus’ Catheter Earns FDA Clearance
Tractus Vascular has received 510(k) clearance for its Tractus crossing support catheter (CSC), which has been cleared in various lengths and guidewire compatibilities.
The catheter is used during interventional procedures in the peripheral and coronary vasculatures to support a guidewire and enable access in hard-to-reach regions. It allows guidewire changes and gives a channel for saline solutions and contrast media.
The Tractus CSC has been cleared for 0.014, 0.018 and 0.035 guidewire compatibilities and 90, 135, 155, and 170 centimeter lengths.
TGA Approves Mallinckrodt’s Uvadex for Use with Cellex Platform
Australia’s Therapeutic Goods Administration (TGA) has granted Mallinckrodt approval for use of its cancer drug Uvadex (methoxsalen) with the Therakos Cellex photopheresis system for treating adults with chronic graft versus host disease (cGvHD) and skin manifestations of cutaneous T-cell lymphoma (CTCL).
The treatment — in which blood is removed from the patient by machine and white blood cells are isolated and then exposed to medication, followed by irradiation and return to the patient — is indicated for cGvHD in adults following stem cell transplantation and palliative treatment of skin manifestations of CTCL that doesn’t respond to other treatments.
The Cellex platform combines cell collection, photoactivation and reinfusion technologies in a single closed system and can be operated by a single person.
FDA Clears HeartVista’s AI-Assisted Cardiac MRI Software
The FDA granted HeartVista 510(k) clearance for its One Click AI-assisted magnetic resonance imaging acquisition software for use in cardiac MRIs.
The software provides standard cardiac views in just ten seconds while the patient breathes freely, taking the complexity and long scan times out of cardiac MRIs.
The software also flags when the image quality is subpar and prompts the operator to reacquire the images if they wish.