CE mark for Harvest Technologies’ Bone Marrow Aspiration system means that, for the first time, European critical limb ischemia patients, at severe risk of amputation, now have a treatment option.
Approval/Clearance
EU TAVI Competition Hotting Up As St. Jude Gets CE Mark For Portico Valve
St.Jude Medical, Inc.says its newly CE marked transcatheter valve is uniquely re-sheathable prior to full deployment, so could potentially lead to improved, accurate placement and reduced paravalvular leak compared with the first generation products.
FDA Clearance And U.S. Commercialisation For Vitacon Bladder Scanner
Norwegian company Vitacon has announced the FDA 510(k) clearance of its clever non-invasive bladder scanner, which seems to tap into new reimbursement guidelines. The company has employed a U.S. partner to drive its commercialisation efforts.
CE Mark For Veryan’s BioMimics 3D™ Stent
UK vascular device specialist Veryan Medical has developed a stent design technology which aims to mimic the helical shape of peripheral vessels in the hope that this will have a vasoprotective effect and furthermore reduce risk of deformation and vessel trauma during leg flexion.
FDA Approval Means Zilver® PTX® Is First Drug-Eluting PAD Stent In U.S.
Peripheral vascular disease treatments have shuffled under the spotlight in recent months with a seemingly endless trail of new devices and approvals for unblocking diseased vasculature. Now Cook Medical can say it has the first drug-eluting stent to be FDA approved for the job.
Ovation Stent Graft PMA Means Small Femoral Arteries No Longer A Barrier To EVAR
Just over two years after it was CE marked, TriVascular’s Ovation Stent Graft, suitable for use in patients with small vascular access and challenging anatomy, has gained full approval in the United States.
New Approval Means Cordis Has First Stent In The U.S. With SFA And Iliac Indications
J&J subsidiary, Cordis Corporation has announced that the U.S. FDA has approved its S.M.A.R.T.® CONTROL® Vascular Stent Systems for use in the superficial femoral artery and/or the proximal popliteal artery.
FDA Expands Indications For Medtronic Valiant Thoracic Stent Graft
Medtronic’s Valiant Thoracic Stent Graft has become the second device to be FDA approved for use in all descending thoracic aortic aneurysms without dissections.
FDA Clears New Steroid-Releasing Implant For Chronic Sinusitis Patients
A new steroid-releasing implant for the treatment of chronic sinusitis has gained the FDA nod and will be available across the U.S. shortly.
FDA Clears Halt Medical’s Acessa™ Uterine Fibroid Treatment
Halt Medical, Inc. announced today at the opening session of the AAGL Global Congress on Minimally Invasive Gynecology that the FDA has cleared Acessa™, a revolutionary new medical technology for treating millions of women suffering from uterine fibroids.
X-spine Signals Intent With Two New FDA Clearances
Spinal device company X-spine Systems Inc. has announced two new U.S. FDA clearances for its products: The Fortex ™ CoCr Rod System and the Certex™ Cervico-thoracic Fixation System.
FDA 510(k) Clearance For Accuray’s CyberKnife® M6™ Series
Accuray company, today announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new CyberKnife M6(TM) Series. The CyberKnife M6 Series features expanded clinical capabilities, reduced treatment times and an enhanced patient experience.
CE Mark For Smiths Medical’s New Safety IV Catheter
Smiths Medical’s newly CE marked safety IV product helps protect clinicians and healthcare workers from unintended needlesticks.
CE Mark For Boston Sci’s SYNERGY™ Everolimus-Eluting, Bioabsorbable Polymer Coated Platinum Chromium Coronary Stent
Boston Scientific Corporation has announced CE Mark approval for the Synergy™ Everolimus-Eluting Platinum Chromium Coronary Stent System featuring its ultra-thin abluminal bioabsorbable polymer coating which holds the promise of reducing late adverse events.
FDA 510(k) Clearance For Thermedical™ RF Ablation System For Larger Tissue Volumes
Thermedical™, a medical equipment company developing new tissue-ablation therapies, has received U.S. FDA clearance to market its innovative technology for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
Tummy Tuck TissuGlu® Over First PMA Hurdle
Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, has announced that it has received approval from the U.S. FDA for the first of four modules of the Company’s PMA filing plan for its TissuGlu®Surgical Adhesive product.