Axonics Modulation Technologies, Inc., a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced that it has received U.S. Food & Drug Administration (FDA) approval under a premarket approval supplement for 3T full-body magnetic resonance imaging (MRI) conditional labeling for the Axonics r-SNM System®. In September 2019, the FDA approved th

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CARAG AG, a privately-held Swiss medical device development company, today announced receiving U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for its Carag Bioresorbable Septal Occluder (CBSO). The CE-marked CBSO is the first-ever transcatheter septal occluder with bioresorbable, metal-free framework. Carag's first U.S. trial is designed to enroll up to 250 patients in a staged study approach, the largest clinical trial for the company to date.

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LivsMed Inc. recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new ArtiSential™ Bipolar Maryland Dissectors. This completes its energy product line, which also includes the Bipolar Fenestrated Forceps, Monopolar Hook and Monopolar Spatula. ArtiSential™ instruments feature a double-jointed end effector and an ergonomic grip that facilitates wristed movements to provide 7 degrees of freedom. These capabilities a

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MedAlliance has announced the award of its second CE Mark: SELUTION SLR™ 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad range of balloon sizes, from 1.5 x 10mm up to 5.0 x 40mm. This award was supported by one-year results from the SELUTION SLR First-in-Human study, involving 56 patients enrolled across six

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InterSystems, a creative data technology provider dedicated to helping customers solve the most critical scalability, interoperability, and speed problems, today announced that leading private healthcare provider MercyAscot has gone live with InterSystems TrakCare’s Patient Administration and Billing functionality during New Zealand’s COVID-19 lockdown, with a full clinical deployment to follow. The final preparations and go-live itself were supported remotely using vide

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Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announces today the market availability of two single-use electrosurgical knives for Endoscopic Submucosal Dissection (ESD). Olympus, a leader in ESD, is introducing to the U.S. the 510(k) cleared HookKnifeJ for the esophagus, stomach and colon and the TriangleTipKnifeJ for the esophagus and stomach. The TriangleTipKnifeJ 510(k) clearance comes with a specific indication f

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International medical imaging IT and cybersecurity company Sectra has signed a digital pathology contract with Region Västmanland in Sweden. The healthcare region already uses Sectra's software for handling medical images, which will now be expanded to also include digital pathology as it digitizes its pathology department. Using the same system to store and view images and information from various diagnostic specialties enables integrated diagnostics, which is key for efficient canc

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OpenText™ announced Rapid Radiology, one of the largest teleradiology providers in the U.S, has selected OpenText™ EMR-Link™ as its comprehensive solution for electronic medical record (EMR) integration and computerized physician order entry (CPOE). Rapid Radiology will use OpenText™ EMR-Link™ to streamline the delivery of radiology test results to EMR charts at healthcare facilities. This will include senior and long-term care facilities with more vuln

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