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From Medical Design & Outsourcing

• Spineology system gains FDA de novo status
  Spineology this week announced it received an FDA de novo grant for its minimally invasive OptiMesh Expandable Interbody Fusion System. The grant follows the successful completion of its Spineology Clinical Outcomes Trial investigational device exception trial. The data showed substantial improvements in lower back pain and a reduction in functional limitations at six, 12 and… […]
• BioAffinity Technologies CEO Maria Zannes talks cancer detection, women in medtech
  Maria Zannes and her company BioAffinity Technologies are seeking to up the game on lung cancer detection. Here’s how. Maria Zannes’ path to a leading role in the medtech field wasn’t quite a conventional one. The one-time aspiring journalist carved out a role on Capitol Hill, first as an aide, then as a lobbyist, plus… […]
• Trelleborg expands Minnesota plant
  Trelleborg Healthcare & Medical recently announced that it has completed an expansion at its Delano, Minn.–based manufacturing facility. The expansion includes a 6,000-ft2 ISO Class 7 cleanroom and enhanced silicone molding and contract manufacturing capabilities. The expansion is a response to increased demand that Trelleborg has been seeing for silicone-molded components, It includes new presses… […]
• RTI Surgical gains 510(k) clearance for compression plate
  RTI Surgical this week announced that it received FDA 510(k) clearance for its Dynamic Active Compression Plate. The plate is designed to provide stabilization and fixation for small bones in the foot. It improves fusion procedures in the foot by combining the rigid stability of a plate with the continuous compression from nitinol material. “The… […]
• FDA to clarify role of off-label uses in medical device approvals
  The FDA has released proposed regulations to make clear that off-label use of a device alone will not be enough to sway the agency to give its blessing to that use. Regulators need more evidence, and the proposed guidance gives examples of direct and circumstantial evidence they would — and would not — consider in… […]
• Greenlight Guru launches quality system tracing software
  Greenlight Guru has announced a new software platform designed to offer users closed-loop traceability within their quality management systems. The Indianapolis-based company said its Visualize software’s machine-learning capabilities allow medical device companies to see, understand and interact better with their quality systems to boost productivity and avoid regulatory problems. “Today, 45% of medical device professionals… […]
• Japan PMD Act revises fast-track reviews for some medical devices, IVDs
  By Stewart Eisenhart, Emergo Group Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the… […]
• Could this be the future of trade shows?
  Medical laser company Lumenis plans to circumvent the pandemic-induced lack of trade shows by taking its wares on the road this month. The first-ever LuMobile cross-country tour will bring the Yokneam, Israel-based company’s flagship products  to practitioners in 20 U.S. cities via an outdoor trade show exhibit. The tour will kick off in Chicago and… […]
• 12 surgical robotics companies you need to know
  Surgical robotics remains a hot area in medtech — even as it faces headwinds from the COVID-19 pandemic. Intuitive Surgical (NSDQ:ISRG) pioneered robotic surgery through the early 2000s and remains the dominant player, but major companies including Medtronic (NYSE:MDT) and Johnson & Johnson (NYSE:JNJ) have big plans to enter the space and compete. Meanwhile, Stryker (NYSE:SYK) has built a… […]
• Patient safety group: Most KN95 masks inferior
  Up to 70% of KN95 masks tested by patient-safety organization ECRI do not meet U.S. standards for effectiveness, the group announced today. The findings indicate increased risks of contracting COVID-19 for care providers and patients at hospitals and other healthcare organizations that imported the masks from China, according to the Plymouth, Pa.-based, not-for-profit group. ECRI… […]
• FDA updates adverse-event database
  In a long-promised move, the FDA today announced that it has added several updates to its database of injuries and deaths reportedly related to medical devices. The agency said it now includes new adverse-event summaries, the number of events and exemption number fields in its eMDR, eSubmitter and Manufacturer and User Facility Device Experience Database… […]