Paragonix Technologies, Inc. announced the presentation of new clinical data at the American Transplant Congress (ATC) on the successful use of the Paragonix SherpaPak™ Cardiac Transport System (CTS) for high-risk donor hearts at the Medical University of Vienna - Allgemeines Krankenhaus Wien (Vienna, Austria), a leading European heart transplant center. Prof. Dr. Andreas Zuckermann, the Director of Cardiac Transplantation at the Medical University of Vienna, presented a serie

General Biologicals Corporation (GBC), a Taiwanese medical device company has developed the GB SARS-CoV-2 Real-Time RT-PCR ("PCR Kit"): a reliable molecular testing kit for the detection of the novel coronavirus in humans. This comes amid the continued global battle against COVID-19 and demand for accurate testing remains at an all-time high, particularly in affected countries such as the US. The PCR Kit is an in-vitro nucleic acid amplification test (NAT) for the qualitat

MedLever is pleased to announce the release of a new solution built on the MedLever Platform™ for workflow automation and interoperability. To bring this unique offering to market, MedLever partnered with Legion Healthcare Partners and incorporated Legion's center development know-how, patient acquisition, and prior authorization expertise. MedLever's solutions are designed to manage workflow across the full patient care cycle for both in-clinic and remote staffing par

Magstim, the global leader in Transcranial Magnetic Stimulation (TMS), today announced an agreement to acquire the product portfolio of Electrical Geodesics, Inc. (EGI) from Royal Philips (NYSE:PHG; AEX: PHIA), a global leader in health technology. EGI designs non-invasive multimodal technologies to monitor brain activity and deliver transcranial electrical stimulation in brain research. Magstim will acquire EGI hardware, software and sensor nets assets and will immediately manage global sale

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

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.

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

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

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

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