Regulatory

Sky Medical Technology wins further FDA clearance to market the new (W3) geko™ device variant for venous insufficiency and ischemia

DARESBURY, England, March 25, 2022 /PRNewswire/ –Sky Medical Technology Ltd (Sky) has today announced it has achieved further U.S. Food and Drug Administration (FDA) 510(k) clearance to market the new (W3) geko™ device variant, for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia. This latest […]

HLT®, Inc. Gains FDA Approval for Two TAVR Clinical Studies

The studies will assess the performance of its HLT Meridian® TAVR® Valve System to treat aortic stenosis and aortic regurgitation for high-risk patients suffering from aortic disease MAPLE GROVE, Minn., March 24, 2022 /PRNewswire/ — HLT Inc., a Bracco Group Company and a leader in the development of cutting edge transcatheter aortic valve replacement (TAVR) therapy, […]

Cerus Endovascular Receives U.S. Food and Drug Administration 510(k) Clearance of its 027 Micro-catheter

–  Company Announces Expansion of its Contour Neurovascular System™ Platform – FREMONT, Calif. and OXFORD, England, March 23, 2022 /PRNewswire/ — Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 027 micro-catheters, available in two lengths, expanding […]

Artio Medical Receives FDA Clearance for Solus Gold™ Embolization Device

Company Prepares for US Commercial Launch PRAIRIE VILLAGE, Kan., March 22, 2022 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and cardiology markets, today announced it received US Food and Drug Administration (FDA) clearance for its Solus Gold Embolization Device, a next-generation product for peripheral vascular […]

Philips Collaboration Live integrated tele-ultrasound expands FDA 510(k) clearance for remote diagnostic use to additional mobile platforms

March 11, 2022 Industry first integrated, diagnostic quality tele-ultrasound technology lets clinicians talk, text, screen share, and transfer control to remote colleagues in real time New functionality helps increase diagnostic confidence on compatible clients including iOS, Android, Chrome web browser and Windows Peer reviewed data on efficacy and efficiency presented at […]

S.M.A.R.T. RADIANZ™ Vascular Stent System Approved for Transradial Use in the U.S.

Completes the RADIANZ Radial Peripheral System™; signals Cordis’ renewed investment in innovation MIAMI LAKES, Fla., March 10, 2022 /PRNewswire/ — Cordis, a global cardiovascular technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the S.M.A.R.T. RADIANZ™ Vascular Stent System, a self-expanding stent purposefully engineered for radial peripheral procedures. […]

CIRCA SCIENTIFIC HAS RECEIVED FDA CLEARANCE FOR NEW ESOPHAGEAL TEMPERATURE PROBE THAT IS VISIBLE ON 3D CARDIAC MAPPING SYSTEMS

S-CATH™ M is the only rapid-response, high-density esophageal temperature probe that is visible on 3D cardiac mapping systems. ENGLEWOOD, Colo., March 3, 2022 /PRNewswire/ — CIRCA Scientific, Inc. announced today that its S-CATH™ M Esophageal Temperature Probe is now cleared for sale in the United States. The new S-CATH M Probe can be […]

Ra Medical Systems Files 510(k) Application for the DABRA Catheter with Braided Overjacket and Six-Month Shelf Life

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces the filing of a 510(k) application with the U.S. Food and Drug Administration (FDA) for the company’s next-generation DABRA catheter with a braided overjacket and […]

InspireMD Announces the Inclusion of its CGuard Carotid Stent in CREST-2 Trial Following FDA Approval of the Investigational Device Exemption Supplement Application

– CGuard™ Carotid Stent will now be a treatment option in the stenting plus medical therapy arm of the trial for patients – – CREST-2 Trial is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and actively engaged at more than 140 study locations – TEL AVIV, Israel, Feb. […]

US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction – FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, […]