Approvals

CleanCision System Earns CE Mark Approval

Prescient Surgical received CE mark approval for its CleanCision system designed to prevent surgical site infections.

The approval means that the system is now available to European hospitals that face high rates of surgical site infections in colorectal and other abdominal surgeries.

CleanCision uses both wound protection and irrigation in its retraction system, allowing it to actively clear harmful bacteria that invade incisions made during surgery.

MicroVention Gains Expanded Indications for Sofia Catheter

The FDA cleared an expanded indication for MicroVention’s Sofia catheter designed for intracranial access.

The Sofia catheter is designed for precise delivery of multiple neurovascular therapies and is used for distal navigation, allowing it to provide support close to the site of treatment.

The device is now cleared for contact aspiration procedures to treat astute ischemic stroke. It received a CE Mark in the EU for the same indication in 2015.

AMG Receives CE Mark Approval for Biodegradable Stent

German-based medical device company AMG received a CE Mark for its Archimedes biodegradable biliary and pancreatic stent.

AMG’s product is a fully biodegradable stent used for obstructed biliary or pancreatic ducts. It can potentially reduce complications that may arise from plastic stents and removal procedures.

The Archimedes stent degrades completely via hydrolysis in approximately 12, 20 or 77 days depending on its composition.

PerkinElmer’s EuroImmun Cleared by FDA

The FDA gave 510(k) clearance to PerkinElmer’s EuroImmun Crithidia luciliae immunofluorescence test (CLIFT) and CLIFT sensitive assays.

CLIFT testing is important in detecting anti-double stranded DNA, one of the markers for the severe rheumatic autoimmune disease known as Lupus.

The EuroImmun’s sensitivity helps reduce false negative results and improve confidence in lupus diagnoses.

Tilak Gains CE Mark Approval for Mobile Medical Videogame

Tilak received CE Mark approval for its therapeutic mobile videogame, Odysight, which triggers medical tests for follow-up of patients with chronic eye diseases.

The game, which is only available via prescription, monitors the evolution of visual parameters, such as near visual acuity, contrast sensitivity and the presence of scotomas or metamorphosis.

Using the medical mobile game app, the ophthalmologist can follow the patient in real time or during the consultation to track changes in the patient’s visual parameters through an online dashboard.

B. Braun Receives 510(k) Clearance for Space Syringe Pump

B. Braun gained 510(k) clearance from the FDA for its Perfusor space syringe pump, a wireless device that offers interoperability in various care and transportation settings.

The pump is cleared for use with air and road transportation and has an integrated piston brake to help prevent unintentional delivery of medication when changing the syringe.

The device includes a microprocessor to allow for independent modular use, which helps prevent catastrophic pump failures and channel confusion.

BayLabs’ Automated Ejection Fraction Software Cleared by FDA

The FDA granted 510(k) clearance to BayLabs’ EchoMD AutoEF software for fully automated AI echocardiogram analysis used in cardiovascular imaging.

The software features fully automated clip selection and calculation for left ventricular ejection fraction — a calculation widely used for measuring cardiac function such as the heart’s pumping efficiency that forms the basis for many clinical decisions.

The EchoMD AutoEF’s algorithms remove the need to manually select clips and views, automatically manipulating them for quantification.

Neural Analytics Obtains CE Mark for Robotic Ultrasound System

Medical Robotics Company Neural Analytics secured CE Mark certification for its NeuralBot robotic ultrasound system.

The device can regulate its position and orientation with professional guidance, and can help physicians diagnose brain disorders, possibly without the need for more invasive testing.

It can be used with the Lucid M1 Transcranial Doppler Ultrasound System, a device that provides a platform for analyzing brain waveforms, to observe a patient’s blood flow characteristics, which can be used to diagnose multiple neurological disorders.