News and Updates by the Food and Drugs Administration (FDA)
AngioDynamics recently declared the achievement of FDA 510(k) clearance for its NanoKnife System, intended for prostate tissue ablation in individuals with moderate-risk prostate cancer. The approval is a result of the concluding phase of the pivotal PRESERVE clinical trial, which […]
NanoKnife System by AngioDynamics Gains FDA Clearance for Prostate Treatment Read More »
InspireMD has announced the commencement of patient enrollment for its pivotal CGUARDIANS II study. This research will explore the efficacy of the CGuard Prime Carotid Stent System during trans carotid artery revascularization (TCAR) procedures. Dr. Patrick Muck, the co-principal investigator,
InspireMD Kicks Off Critical Study for CGuard Prime in TCAR Practices Read More »
Anteris Technologies has revealed its intention to launch an initial public offering (IPO) in the United States. The company plans to utilize proceeds from the IPO to enhance the progression of its DurAVR transcatheter heart valve innovation. The offering includes
Anteris Technologies Unveils IPO to Boost Heart Valve Innovation Read More »
Stereotaxis (NYSE:STXS) announced the approval of its Magbot magnetic navigation ablation catheter by Chinese regulatory authorities today. This approval comes shortly after the company’s Genesis robotic magnetic navigation (RNM) system received clearance from China’s National Medical Products Administration. Headquartered in
Stereotaxis Gains Chinese Approval for Magnetic Ablation Catheter Read More »
Vicarious Surgical (NYSE:RBOT) recently disclosed that William Kelly, their Chief Financial Officer, has decided to leave the organization in pursuit of other career paths. Kelly began his tenure at the Waltham, Massachusetts-based firm in January 2021, and is slated to
Vicarious Surgical’s CFO Steps Down, No Impact on Robotic Surgery Initiative Schedule Read More »
On [today’s date], Cala Health revealed that it has secured a $50 million growth financing round to enhance its TAPS therapy. Leading the investment were Vertex Growth Fund and Nexus NeuroTech Ventures. All prior investors, including Action Potential, Johnson &
Cala Health Secures $50M in Growth Financing Read More »
Headline: Merck’s investigational treatment, zilovertamab vedotin, in conjunction with the standard R-CHP therapy, delivers a complete response rate (CRR) of 100% at a 1.75 mg/kg dose in a Phase 2 trial targeting previously untreated diffuse large B-cell lymphoma (DLBCL). Content:
Zentiva AG, a fully-owned subsidiary of Zentiva Pharma GmbH based in Frankfurt am Main, Germany, and part of the Zentiva group, has completed its voluntary public tender for the acquisition of shares in APONTIS PHARMA AG (APONTIS PHARMA). Following the
Zentiva Finalizes Buyout Bid for APONTIS PHARMA AG Shares Read More »
Novartis has unveiled promising, long-term results from the pivotal phase III ASC4FIRST trial with Scemblix (asciminib), illustrating superior major molecular response (MMR) rates at the 96-week mark. The research compared Scemblix’s MMR rate against investigator-chosen standard-of-care (SoC) tyrosine kinase inhibitors
The experimental drug datopotamab deruxtecan, also known as Dato-DXd, has achieved Breakthrough Therapy Designation (BTD) in the United States. It targets adult patients who suffer from locally advanced or metastatic non-small cell lung cancer (NSCLC) that exhibits epidermal growth factor