CE Marking and ARCH clinical trial data position the Liverty™ TIPS Stent Graft to expand treatment options for patients with advanced liver disease
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CE Marking and ARCH clinical trial data position the Liverty™ TIPS Stent Graft to expand treatment options for patients with advanced liver disease
Ellipsys Medical, Inc. today announced that the Ellipsys® Vascular Access System will once again be commercially available, with initial availability anticipated in mid-2026. The announcement marks the planned reintroduction of the minimally invasive technology to clinicians and patients following a period of limited market availability. The Ellipsys System, previously available...
Inaugural case performed by spine surgeon Dr. Scott L. Parker highlights the system's strength, versatility, and precision for supporting multi-level spinal constructs
On March 12, 2026, the first implant of the ProStyle M® Transcatheter Mitral Valve System (ProStyle M®) was successfully completed under pure ultrasound guidance as part of its confirmatory clinical study. The device is independently developed by KingstronBio Technology (Changshu) Co., Ltd. (KingstronBio). The procedure was performed by Professor Wang Chunsheng and Professor...
Company Appoints D. Keith Grossman to Board of Directors
Mechanism-Driven Study Design Focused on Capital Efficiency and Accelerated Development for Near-Term Value Creation, Addressing a $2 Billion Potential Target Market
Variational AI introduces Enki™ 4: an improved algorithm and architecture designed to scale, expanding the pre-trained target coverage from 592 to 760 and now applicable to proximity-based therapeutics and novel payloads for antibody drug conjugates
Akira Kitamura, GM, AI Drug Development Division of NEC Corporation and CEO of NEC Bio, added, "This agreement is an important milestone in our partnership with Transgene and reflects NEC’s long-term commitment to the development of TG4050
Joint initiative with Rosebud Biosciences, Kantify, and funded by Incite will identify and quantify off-target toxicities in chemotherapy patients
RedBrick AI is building the foundation of healthcare artificial intelligence (AI) with its medical data annotation tools for imagery
With FDA clearance and insurance coverage, Wesper has crafted a clinical-grade solution to deliver sleep medicine to the masses.

In 1976, Congress passed the Medical Device Amendments (MDA) to charge the FDA with reviewing the safety and effectiveness of medical devices. The MDA heavily regulates high-risk medical devices that are capable of supporting human life through a premarket approval process. Read what a litigation associate in BakerHostetler’s Houston office advises.

Author Jon Gingrich, CEO, Echosens North America writes, “Nonalcoholic fatty liver disease (NAFLD) is an asymptomatic and underdiagnosed disease that affects 37% of U.S. adults and 70% of individuals with Type 2 diabetes. Nonalcoholic steatohepatitis (NASH), the more severe form of NAFLD marked by inflammation and ballooning, can lead to hepatic fibrosis, cirrhosis, and hepatocellular cancer (HCC) if left untreated.” Read more.

James A. Joyce writes, “On March 24, 2020, the U.S. Department of Health and Human Services declared that the emergence of COVID-19 justified the Emergency-Use Authorization of drugs, biological products, and medical devices to combat the pandemic. Read what he has to say.
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