The Performance Evaluation Plan outlines the resources and procedures for assessing the IVD’s performance. A separate standard exists for this: EN 13612:2002. It is brief and doesn’t provide extensive detail. You can generally grasp its contents by reviewing the table […]
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Financial experts from Bank of America anticipate a promising scenario for mergers and acquisitions within the medical technology sector by 2025. According to Travis Steed, Stephanie Piazzola, Craig Bijou, and Enjia Cao, the year 2024 represented a “typical year” in
Possible Upsurge in Medical Technology Mergers and Acquisitions by 2025 Read More »
Valencia, California-based SetPoint Medical announced today that they have formally lodged an application for premarket approval (PMA) with the FDA for their neuroimmune modulation device. The company is pioneering this technology as a potential novel treatment option for individuals suffering
SetPoint Medical Progresses Neuromodulation Device Towards FDA Approval Read More »
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 »
Tune into this video to listen as Carmen shares her vision for the perfect makeup creation.
Street Buzz: Makeup Edition – Episode 7| Gen Z’s Iconic Cat Eyes 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 »