Approval/Clearance

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.

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.

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, 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.

NLT Spine’s eSPIN and PROW FUSION™ Together Offer a Complete Lumbar Interbody Fusion Procedure. FDA clearance means the system is good to go.

Sorin has announced CE Mark approval for extended indications of the Perceval™ S sutureless valve, expanding the market and, the company says, paving the way for adoption of Minimally Invasive Cardiac Surgery

EVAR specialist Aptus Endosystems, Inc., has received 510(k) clearance from the U.S. FDA for its thoracic-length HeliFX™ Aortic Securement System.

K2M focuses its efforts on developing devices to address complex spine disorders, so will be delighted to have gained an extended FDA clearance for its clever spinal rod system, which can now be used in adolescent idiopathic scoliosis.

South Korean manufactured Lospa Knee® System from Corentec features cruciate retaining and posterior stabilised knee within a single system

Precision Spine subsidiary Spinal USA, Inc., has received 510(k) clearance from the FDA for the Slimplicity® Solo Anterior Cervical Plate System, adding another important cervical product to its broad and expanding product portfolio.

Teleflex says its Arrow® VPS replaces the need for confirmatory chest X-ray by using state-of-the-art, real-time intravascular Doppler, ECG and advanced algorithmic logic to notify the clinician that the central catheter tip has reached the optimal location.

Covidien has announced that it has received 510(k) clearance from the U.S. FDA for its LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures.

Estech’s breakthrough technology for the first time combines the benefits of a bipolar clamp with the flexibility of an endoscopically guided probe with the capability of creating linear lesions anywhere on a beating heart. It’s for investigational use in AF ablation treatment in U.S right now.

Preventice™, Inc., a leading developer of mobile health applications and remote monitoring systems, announced today that the U.S. FDA has given the company 510(k) clearance for its BodyGuardian Remote Monitoring System.

Abiomed Receives FDA 510(k) Clearance for New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows of 4L/min

Californian vascular device company Endologix, Inc., has gained CE Mark approval of the current version of its unique Nellix® EndoVascular Aneurysm Sealing System which involves filling the aneurysm sac with a bag full of a biostable polymer in patients with abdominal aortic aneurysms.