Press Release: FDA approves the Syncardia total artificial heart with Synhall valves

From Medical Design & Outsourcing

• FDA to launch ‘Digital Center of Excellence’
  The FDA announced this week that it will launch a “Digital Health Center of Excellence” within the Center for Devices and Radiological Health (CDRH). The center will focus on the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device and technologies used… […]
• AdvaMed launches campaign against ‘misleading’ legal advertising
  Medtech trade group AdvaMed this week debuted a website that tracks law firm TV advertisements aimed at patients who have had certain medical devices implanted. The “Responsible Advertising for Patient Safety” site says that such ads mislead patients into legal action against the manufacturers of devices that are “non-faulty” and may jeopardize patient safety. “We… […]
• What are the top COVID-19 vaccine candidates?
  Five COVID-19 vaccine candidates are going through Phase 3 clinical trials to prove safety and efficacy. Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New York Times. With the U.S. alone topping 200,000 COVID-19… […]
• 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… […]