Bolton Medical has announced the FDA’s approval of its Relay® Thoracic Stent-Graft with Plus Delivery System. The device is designed to address the needs of physicians performing minimally invasive surgery for thoracic aortic aneurysms and penetrating ulcers.
Regulatory
Amedica Receives FDA 510(k) Clearance For A Second Generation Interbody Fusion Device System
Amedica Corporation, a spinal and reconstructive medical device manufacturer, announced today it has received FDA 510(k) clearance to legally market a second generation family of cervical and lumbar interbody fusion devices manufactured with the company’s proprietary Silicon Nitride biomaterial. The product offers design enhancements the company says will allow surgeons to perform minimally invasive and lumbar lateral interbody fusion approaches.
Newly Cleared ReForm™ Pedicle Screw System Represents A Metamorphosis In Pedicle Screw, Rod And Instrumentation Technology
New Jersey device company Precision Spine, Inc. has announced that it has received 510(k) clearance from the FDA its ReForm Pedicle Screw System. Physician/Developer says it will increase efficiency of application and ease ergonomic use.
CE Mark Sees CoreValve® Evolut™ Range Extend To Include 23mm Version
Medtronic announces CE mark for CoreValve® Evolut™, incorporating features designed for optimal fit. With the new 23mm iteration, Medtronic claims its CoreValve family treats the broadest range of patient valve sizes.
Stryker Recall Of Neptune Rover Waste Management System
On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. Now that recall has been expanded to other iterations of the device because it appears they have been marketed without 510(k) clearance which FDA deems necessary in order to establish their safety and efficacy.
So No EU PMA, But PIP Still Casting It’s Slightly Incongruous Shadow
Addressing the PIP situation with heightened regulatory controls is playing to the crowd, especially when most of the new rules relate less to one act of fraud than they do ostensibly to innovation in the interests of patients.
EU Device Regs Press Conference… Closing Question Suggests Increased Costs Met By Industry
Medical Device Regulation in Europe is changing. Today’s press conference should highlight the main points
New EU Device Rules Announced
As we’ve already noted, today’s the day when the EU commission announced the results of its lengthy rehash and consultations of the medical devices directive.
It’s The Big Day! Anticipated Changes To EU Device Regulations Will Have A Huge Impact
Today is indeed the day on which we welcome the adoption of a new set of medical device regulations, to become law from 2015. It’s about time too in our view because the credibility of the current EU set-up has been damaged by public dissection following a number of high profile product problems.
FDA 510(k) Clearance For Teleflex ARROW® FlexBlock™ Continuous Peripheral Nerve Block Catheter
Device company Teleflex Inc. has announced the FDA 510(k) clearance of its Arrow® FlexBlock continuous peripheral nerve block catheter designed for clinicians who use ultrasound guidance when placing peripheral nerve block catheters.
CE Mark For Medtronic’s New Oxygenation System
Medtronic, Inc. has announced CE Mark for its new Affinity Fusion® oxygenation system, opening the door to a European launch. The system, which oxygenates and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for claimed patient safety and ease of use.
HyperBranch Completes Clinical Enrollment In FDA Dural Sealant Study
Hyperbranch possesses its own particular hydrogel which is already sold in Europe as a dural sealant for use following neurosurgery. Now the company has taken a step towards FDA approval with the news that it has completed enrollment in its pivotal IDE study.
CE vs PMA Study Shows Little Difference In Recalls, Big Difference In Time To Market. But Surely It’s Much More Complicated Than That.
Taken at face value some new data and reporting suggests that a U.S. style PMA might deliver little benefit in terms of patient safety, yet delay innovations from reaching the market by 43 months. We argue it’s more subtle than that.
CE Mark For St.Jude’s Eon™ Mini Migraine Neurostimulator
St. Jude Medical, Inc. has announced it has received European CE Mark approval of its Eon™ family of neurostimulators for patients with intractable chronic migraine. The range includes the Eon Mini, which St.Jude says is the world’s smallest rechargeable neurostimulator with the longest-lasting battery in its class.
Intelomed Receives FDA 510(k) Clearance For CVInsight Medical Device
Intelomed, Inc., has announced that it has received FDA 510(k) clearance for its CVInsight medical device which measures and displays vital information such as functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate of adult and pediatric patients.
UK Device Alert: Covidien’s Shiley™ Tracheostomy Tubes
Certain of Covidien’s Shiley, reusable cannula, cuffed trachoestomy tubes appear to have leakage and disconnection issues, which has lead to the UK’s MHRA issuing a Medical Device Alert.