FDA Proposes Major Changes to Medical Device Quality Regulations

  • Medtronic and Amazon plan colorectal cancer screenings in underserved communities

    Medtronic (NYSE:MDT) and Amazon (NASDAQ:AMZN) today announced plans to donate 50 Medtronic GI Genius modules to endoscopy centers serving low-income and underserved communities across the United States. . One of the goals is to improve the detection of polyps that can lead to colorectal cancer, which is the most common cancer in adults in the United States… […]

  • Hugo’s comments are positive as Medtronic plans to scale up production of surgical robot

    Medtronic’s (NYSE:MDT) surgical robot Hugo may soon be back on track as the company seeks to ramp up production. Speaking on the company’s third quarter earnings call, as transcribed by SeekingAlpha, Medtronic Chairman and CEO Geoff Martha confirmed that the medical technology giant has made progress in the improving its supply chain and manufacturing. As a result, Medtronic is now looking to ramp up production… […]

  • FDA Proposes Major Changes to Medical Device Quality Regulations

    The FDA today released a long-awaited proposal to revise US medical device quality regulations to bring them more in line with global regulations. The proposed rule, Medical Devices; Changes to quality system regulations incorporate ISO 13485:2016, the international consensus standard for medical device manufacturers. The reduced complexity of the regulatory process could allow the FDA to realize savings in the… […]

  • Memic Innovative Surgery partners with VirtaMed to develop robotic surgery simulation

    VirtaMed and Memic Innovative Surgery announced today that they will work together to develop virtual reality simulations for surgeons trained on Memic’s Hominis Surgical System. The FDA-cleared Hominis surgical robot features small, humanoid-shaped arms that include shoulder, elbow, and wrist joints to provide human-level dexterity and 360-degree articulation. The surgical robotics system has an indication… […]

  • Supreme Court’s Arthrex ruling creates more scrutiny for patentees — and more questions

    A confirmation from the Director of the Patent and Trademark Office may resolve some issues, but it is not yet clear how discretionary review will continue to evolve. Angeline Premraj, Troy Viger, and Kathleen Daley, Finnegan The US Patent and Trademark Office’s inter partes examination process is a popular way to challenge the validity of a patent outside of litigation.… […]

  • How Tiny Solid-State Batteries Enable Smaller Implants That Charge Faster

    With a solid electrolyte, high energy density and thin packaging, solid-state batteries are becoming smaller and allowing devices to be implanted in more parts of the body. Denis Pasero, Ilika It has been more than six decades since Åke Senning implanted the first pacemaker in a patient. Although today’s pacemakers have improved the treatment… […]

  • What happens when bionic eye implants suddenly darken?

    An update on the Second Sight Medical Products (NASDAQ:EYES) saga comes to us via IEEE Spectrum, offering a cautionary tale for cutting-edge implant developers and the patients who trust them. The future remains cloudy for the Los Angeles-based developer of the Argus 2s retinal prosthesis system, which is… […]

  • Insulet and Nintendo use ‘Animal Crossing’ video game to promote inclusion of diabetes community

    Insulet (NSDQ:PODD) today announced that new features that will debut on Nintendo’s Animal Crossing video game are inspired by people with diabetes. Insulet, based in Acton, Massachusetts, aims to promote representation and inclusion of the diabetes community through activation on Animal Crossing: New Horizons. Discover the full story on our sister site, Drug Delivery Business News. […]

  • Integer beats The Street in the fourth quarter

    Integer Holdings (NYSE:ITGR) today reported fourth quarter results that beat consensus forecasts on Wall Street, projecting an even better 2022 as it works through the effects of the omicron variant surge of COVID- 19. The Plano, Texas-based medical device contract manufacturing giant earned $23.8 million, or 71¢ per share, on sales of $313.0 million for the quarter… […]

  • Confluent Medical Technologies closes majority investment by TPG Capital

    Confluent Medical Technologies announced the closing of a majority investment by TPG Capital following TPG’s agreement to acquire a majority stake in the company. Last month, Confluent Medical confirmed that TPG Capital had signed a definitive agreement to acquire a majority stake in the company, joining existing investor Ampersand Capital Partners, which retains a substantial minority… […]

  • Microsoft CMO: Using the cloud to improve the design, manufacture and service of medical technologies

    Dr. David Rhew, Microsoft’s global medical director and vice president of healthcare, has studied how technology can improve health outcomes for nearly three decades. His long-standing focus has been on access to care, quality of care, patient safety, improving the experience of patients and providers, and finding ways to improve overall efficiency of care. … […]


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