OncoSec Medical has obtained CE certification for its proprietary gene and drug delivery technology, designed to treat solid tumor cancers. The assessment and certification process was supervised by SGS Group, a provider of inspection, ...
Tags: OncoSec, CE certification, proprietary gene, drug delivery technology
OncoSec Medical has obtained ISO 13485 quality management system (QMS) certification for the design, development, manufacture, and distribution of its electroporation device including the OncoSec medical system (OMS). Currently being used ...
Tags: OncoSec Medical, OncoSec medical system, OMS
Boston Scientific has obtained CE mark approval for its Synergy Everolimus-Eluting platinum chromium coronary stent system, designed to improve post-implant vessel healing. The coronary stent, which features a combination of ...
The US Food and Drug Administration (FDA) has cleared Loma Vista Medical's TRUE Dilatation Balloon Valvuloplasty catheter, designed to prevent balloon ruptures in balloon aortic valvuloplasty (BAV) and transcatheter aortic valve ...
Tags: FDA, Loma Vista, Balloon Valvuloplasty catheter, BAV
AMTAC Certification Services has granted CE mark for CellAegis Devices's autoRIC device. The CE mark allows CellAegis to sell autoRIC Device to 32 member countries and seven cooperating countries of the european economic area, under ...
Tags: AMTAC, CE Mark, medical device
Boston Scientific has completed enrolling first patient in REPRISE II clinical trial, designed to assess the safety and efficacy of the Lotus Valve system in minimizing aortic regurgitation (leaking). The Lotus Valve system, which the ...
Tags: Boston Scientific, first patient, REPRISE II clinical trial
W. L. Gore & Associates has completed enrolling first patient in a clinical trial of its GORE Septal Occluder, designed for the percutaneous, trancatheter closure of ostium secundum atrial septal defect (ASD). The device features a ...
Tags: Gore, first patient, clinical trial, Septal Occluder, ASD
ETView Medical has obtained CE mark approval for its VivaSight-DL airway management system. Single-use, disposable VivaSight-DL system comprises of a dual lumen airway ventilation tube with an integrated, continuous high-resolution video ...
Philosys, a contract design, development and manufacturing company, has obtained CE mark approval for its new Gmate SMART blood glucose monitor. By using the operating system of the smart phone, the patent pending technology of the Gmate ...
Tags: Philosys, Gmate SMART blood glucose monitor, Gmate SMART
Medtronic has gained CE mark for its Viva/Brava portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices. The family of CRT-Ds features a new algorithm, called AdaptivCRT, which by preserving patients' normal ...
Tags: Medtronic, CE mark, CRT-D devices, AdaptivCRT, CRT treatment
Medtronic has introduced the Endurant II AAA Stent Graft system in the US, following the US Food and Drug Administration's (FDA) approval. The Endurant II AAA Stent Graft system is designed for the treatment of abdominal aortic aneurysms ...
Tags: Medtronic, Endurant II AAA Stent Graft system, FDA, EVAR
Medtronic has completed enrolling patients in a clinical trial of its Amphirion drug-eluting balloon, designed to treat critical limb ischemia. The CE-marked Amphirion drug-eluting balloon features proprietary FreePac proprietary ...
Tags: Medtronic, clinical trial, limb ischemia, Amphirion drug-eluting balloon
CardioKinetix has started enrolling patients for its PARACHUTE III, a post-market safety surveillance trial, in Germany. The dual-arm, multi-center, open-label trial, which will enroll up to 100 ischemic heart failure patients, is ...
AirXpanders has obtained CE mark approval for its needle-free, patient-controlled tissue expander, designed for patients undergoing breast reconstruction after a mastectomy. The new technology, AeroForm, incorporates new capabilities ...
Tags: AirXpanders, AeroForm, mastectomy
Global healthcare firm Abbott's everolimus eluting coronary stent system has been accorded with CE Mark in Europe. The XIENCE Xpedition everolimus eluting coronary stent system, which is used to treat coronary artery disease, provides ...
Tags: Abbott, CE mark, coronary stent system, coronary artery disease