Approvals

FDA Approves New Indication for Abbott’s MitraClip

The FDA approved a new indication for Abbott Vascular’s MitraClip heart valve repair device for reducing mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left atrium.

The device was first approved in 2013 for reducing mitral regurgitation in certain patients whose significant mitral regurgitation and heart failure symptoms resulted from abnormalities of the mitral valve. The new indication is for treatment of patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function.

Admedus Earns CE Mark for Collagen Bioscaffold

Admedus earned the CE Mark for its VascuCel collagen bioscaffold, a device used in a wide variety of vascular surgical procedures.

The device is strong but pliable and designed for good suturability. It is bioengineered using the company’s proprietary ADAPT technology and has been used with success in cardiac repairs and reconstructions.

The bioscaffold reduces the need for agents to stop bleeding due to its hemostasis capabilities and is ready for use off the shelf with no rinsing required.

Sonavex’s Blood Flow Monitor Cleared

Sonavex’s blood flow monitoring device EchoSure received 510(k) clearance from the FDA, allowing surgeons to monitor a patient via a mobile device.

The ultrasound technology “may enable detection of vascular compromise earlier than clinical observation alone, providing opportunities for more rapid intervention and improved patient outcomes,” said Sonavex President and Chief Medical Officer Devin O’Brien Coon.

The device uses deep learning algorithms with 3D ultrasound imaging to visually and quantitatively measure a patient’s blood flow in real-time after microvascular and vascular surgeries.

Alcyone Lifesciences Gains Breakthrough Device Designation for ThecaFlex

Alcyone Lifesciences earned a breakthrough device designation from the FDA for its ThecaFlex DRx system, indicated for patients aged three or older who need chronic bolus intrathecal treatment.

The device, which is made up of a subcutaneous port and an intrathecal catheter used to access cerebrospinal fluid, helps treat patients with life-threatening, debilitating central nervous system disorders.

The device is designed for patients who cannot undergo lumbar punctures due to spinal anomalies or who are resistant to lumbar punctures needed for therapy administration.

FDA Hands Paige.Ai Breakthrough Designation for Cancer Diagnosis Tool

The FDA awarded Paige.Ai breakthrough device designation for an artificial intelligence system designed to diagnose cancer.

The diagnostic tool reviews digitized slides through an arrangement with a cancer center and funding is available for digitization of four million slides.

The software uses an algorithm that is trained with expert cancer diagnoses and is the first publicly announced AI tool for diagnosing cancer.

Agfa Receives 510(k) Clearance for Imaging System

Agfa received 510(k) clearance from the FDA for its DR 800, a multipurpose imaging system that offers radiography, fluoroscopy, tomography and other advanced clinical applications.

The image processor is equipped with software for better brightness control, enhanced noise suppression and veiling glare reduction.

The device includes software that processes the tomographic slices it generates from a tomographic sweep and can reconstruct images in less than a minute.

Co-Diagnostics Gains CE Mark for ZDC Multiplex Test

Co-Diagnostics received the CE Mark for its Logix Smart Zika/Dengue/Chikungunya in vitro diagnostic test and the company is now producing the multiplex test at its facility in Salt Lake City, Utah.

The Logix Smart test detects the three mosquito-transmitted viruses in patients and distinguishes between them by analyzing their RNA. If a specimen tests positive for Zika, a cerebral spinal fluid sample can be taken to look for neurological infection.

Zika, dengue and chikungunya all have similar symptoms — such as joint pain and severe fever — and thus can be misdiagnosed by physicians.

Saranas Wins Novo Designation for Endovascular Bleed Monitor

The FDA granted Saranas a de novo designation for its Early Bird endovascular bleed monitoring system.

The Early Bird incudes a vascular access sheath equipped with sensors to detect and monitor bleeding from blood vessels that have sustained damage from endovascular procedures like TAVR and hemodynamic support device placement.

The company said that the Early Bird is the only device on the market designed for early bleed detection.