Apollo Endosurgery has obtained CE mark approval for its OverStitch endoscopic suturing system, designed for offering less invasive options during various endoscopic surgical procedures. With the approval, the company is planning to ...
Tags: EU, Endoscopic Suturing System, Medicine
Aptus Endosystems has received CE mark approval from the European Union for its thoracic-length Heli-FX system for thoracic aortic aneurysms (TAA) treatment. Featuring a longer delivery device with additional tip configurations, the ...
Tags: Heli-FX System, Medicine, Medical Device
The European Union (EU) has granted CE mark approval to iTraumaCare's iTClamp Hemorrhage Control System, designed for controlling critical bleeding in seconds. The device seals the edges of a wound to create a temporary pool of blood ...
Tags: iTraumaCare, medical professionals, medical
SOOFT italia, a OOgroup company, has obtained CE mark approval for its iontophoresis device for corneal cross-linking. The device, which includes Ricrolin+ and a new Power Generator I-ON CXL, allows the riboflavin to penetrate in the ...
Tags: SOOFT italia, CE mark, corneal cross linking
Medtronic has gained CE mark approval for its Engager transcatheter aortic valve implantation (TAVI) system with transapical delivery catheter, from the European Union (EU). The new TAVI system, which is inserted in the apex (the lower, ...
Tags: Medtronic, transcatheter aortic valve implantation, TAVI
The European Union has granted CE mark approval to ALung Technologies' Hemolung Respiratory Assist System (RAS) for the treatment of patients with acute hypercapnic respiratory failure including acute respiratory distress syndrome and acute ...
Tags: ALung Technologies, Respiratory Assist System, minimally invasive device
Germany-based Biotronik has obtained CE mark approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. The Ilesto 7 series, which the company claims to include the ...
Tags: ProMRI technology, DF4 connector, MR scans
US-based medical technology provider Boston Scientific said it is launching the new polymer-based drug-eluting stent (DES) system in the European market as the product has obtained CE mark approval. The Promus Premier everolimus-eluting ...
St Jude Medical has treated the first patient with 25 mm Portico Transcatheter aortic heart valve using the transfemoral delivery system in its ongoing non-randomized, multi-center European trial. Made of bovine pericardial tissue, the 25 ...
Tags: Portico aortic heart valve, Medical, minimally invasive device
Direct Flow Medical has obtained CE mark approval for its transcatheter aortic heart valve system, which features double-ring design for creating a tight and durable seal around the annulus. The Direct Flow Medical transcatheter aortic ...
Tags: Direct Flow Medical, CE mark, Medical Care
Medtronic has received CE mark approval for its Complete SE vascular stent for use in lower extremities, including superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which supply blood to the legs. The ...
European Union has given its CE Mark approval for a diabetic wound management device developed by global medical devices firm Integra LifeSciences. The new device called Integra Flowable Wound Matrix 2 is a flowable version of Integra's ...
Medical device manufacturer St. Jude Medical announced that it has gained European CE Mark approval for its AMPLATZER Amulet Left Atrial Appendage Occluder, a new cardiac device that can prevent heart stroke. According to the US-based ...
Abbott has obtained CE mark approval for its Architect Stat high sensitive Troponin-I assay, designed for evaluating potential heart attacks sooner. The chemiluminescent microparticle immunoassay (CMIA), which is designed for use on ...
Tags: Abbott, CE mark, Architect Stat, potential heart attacks
The European Union has granted CE mark approval to Venaxis's blood-based test which is designed to identify patients at low risk for acute appendicitis. The APPY1 test, which is being initially developed for pediatric, adolescent and ...
Tags: blood based test, acute appendicitis, young adult patients