Mobius Imaging has gained CE Mark approval for its Airo Mobile Intraoperative CT System, distributed under an exclusive sales and service agreement with German company Brainlab.
Regulatory
Final PMA Module Submitted to the FDA, for Superion® Interspinous Spacer System
Minimally invasive spine technologies company, VertiFlex®, Inc., has announced submission of the final module of the pre-market approval (PMA) application to the U.S. FDA to support approval for its Superion® Interspinous Spacer System.
FDA Approves U.S. Clinical Trial Start for CryoLife’s PerClot®
CryoLife, Inc. has received approval of its Investigational Device Exemption (IDE) for PerClot from the U.S. FDA. This approval allows CryoLife to begin its pivotal clinical trial to gain approval to commercialize PerClot in the U.S.
FDA Clearance for Ablative Solutions Peregrine System™ Infusion Catheter
Ablative Solutions, Inc., has received U.S. FDA 510(k) clearance for its Peregrine System™ Infusion Catheter. The system uses a unique, patent-pending technology to deliver diagnostic and therapeutic agents directly to the perivascular layer that surrounds blood vessels.
Sorin’s Perceval™ Sutureless Aortic Valve Now CE Marked for Under 65s
Italian Cardiovascular device specialist Sorin Group tells us its Perceval™ sutureless aortic valve has received CE mark approval for adult age indication allowing treatment of a wider spectrum of patients with aortic stenosis and/or steno-insufficiency.
FDA Clearance for Rotation Medical’s Implantable Collagen Scaffold for Treating Rotator Cuff Disease
Rotation Medical, Inc. tells us it has received U.S. FDA 510(k) clearance for its implantable collagen scaffold technology. The new technology is designed for use during arthroscopic and mini-open procedures to help support clinical management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Intuitive Surgical Introduces “Technological Leap Forward” with New daVinci® Xi™ System
Robot surgery device specialist Intuitive Surgical, Inc., has announced the U.S. FDA clearance and introduction of the da Vinci Xi Surgical System, which it says represents a technological leap forward in replacing large-incision abdominal surgeries (open surgery) with a minimally invasive approach.
Australia Approves NeuroSigma’s Monarch™ eTNS™ System for Drug-Resistant Epilepsy
NeuroSigma gained the European CE mark for its Trigeminal Nerve stimulation system in 2012. Now the Australian TGA has given the device its approval for use in adjunctive treatment of drug-resistant epilepsy.
FDA Approves Abbott’s Supera® Stent to Treat People with Peripheral Artery Disease
Abbott’s Supera® Peripheral Stent System has received U.S. FDA approval to treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). PAD occurs when fat and cholesterol buildup causes arteries outside of the heart to narrow, which reduces blood flow to parts of the body, most commonly the legs. The disease affects 12 to 20 percent of Americans age 65 or older and can cause leg pain, in addition to increasing the risk of heart attack or stroke.
FDA Clears Three New Digital Angiography Systems from Shimadzu
Shimadzu Medical Systems USA has announced that its new digital angiography system family has received FDA 510(k) clearance. The family comprises the ceiling-mounted Trinias, the floor-mounted Trinias, and the Biplane models.
FDA Clears Next Generation Medigus Muse™ System for GERD Threatment
Israeli medical device company Medigus Ltd. has gained U.S. FDA 510(k) clearance for its next generation MUSE™ system, formerly known as the SRS™ system. Muse is a device which enables an incisionless procedure by performing an anterior partial fundoplication with standard surgical staples in a less invasive way.
FDA Approves St. Jude’s Allure Quadra™, Assurity™ and Endurity™ Devices
St. Jude Medical, Inc. has announced approval from the U.S. FDA for the Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which provides additional pacing innovations for physicians to treat patients with heart failure. The company also announced FDA approvals for the Assurity™ pacemaker and Endurity™ pacemaker families of devices.
CE Mark for New “Remote Monitoring” ECG Devices
Israeli heart monitoring company, Aerotel Medical Systems has received the CE Mark approval for its new ECG devices, HeartView P12/8i and HeartView 12L.
CE Mark and EU Launch for St. Jude’s Prodigy Spinal Cord Stimulation System with Burst Technology
St. Jude Medical, Inc. has seen its Prodigy™ Chronic Pain System with Burst Technology gain CE Mark approval, which it says will be followed by European launch.
FDA Clears ProTom’s Radiance 330® Proton Therapy System
Proton Beam Therapy specialist company ProTom International, Inc. has announced that it has received U.S. FDA 510(k) clearance for its Radiance 330 Proton Therapy System.
CE Mark for Medrobotics® Flex® System Means MIS Access to Hard-to-Reach Anatomy
Medical robotics company (the clue’s in the name) Medrobotics Corp., has gained the CE mark for its Flex® System and will initiate a limited commercial launch of the product in select European markets.