From Medical Design & Outsourcing

• Supporting regulatory affairs departments to address clinical requirements under new MDR
  By Dietmar Falke and Jaap Laufer, Emergo Group The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-marketing clinical follow-up (PMCF) data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog… […]
• 5 tips to raise funding for your medical device
  Securing funding can be a long and tedious process, and medical device businesses must work to position themselves as especially attractive to potential investors to maximize success and accelerate the fundraising process. Jon Speer, Greenlight Guru According to Alejandro Cremades, author of The Art of Startup Fundraising, it can take from six to nine months… […]
• FDA recognizes latest ISO 14971 as medical device consensus standard
  By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are… […]
• Synaptive Medical updates Modus V surgical microscope
  Synaptive Medical announced that its U.S. and Canadian Modus V robotic digital microscope now includes updates such as additional 3D visualization and voice-activated control. The Modus V is a robotically controlled digital microscope used as part of Synaptive’s BrightMatter surgical suite designed for less invasive, patient-specific approaches in complex cranial procedures. The Modus V provides similar… […]
• New machine can preserve donor livers for 1 week
  Researchers in Switzerland have built a perfusion machine that can preserve human livers for transplantation for a week or more, potentially slashing the number of donor livers that must be discarded due to time-related deterioration. Existing perfusion technology can preserve a donor liver for up to 24 hours. The team of surgeons, biologists and engineers… […]
• Smiths Medical launches Portex tracheostomy tubes and kits
  Smiths Medical this week launched its Portex polyvinyl chloride tracheostomy tube and kit portfolio. The new polyvinyl chloride (PVC) tube portfolio has options for a variety of patients, according to the company. “Our goal was to create tracheostomy tubes and kits designed to help clinicians provide the best patient care. We’re excited to offer a variety… […]
• FDA clears Cleveland Clinic 3D-printed airway stents
  The FDA recently cleared 3D-printed, patient-specific stents developed by a doctor at the Cleveland Clinic. Cleveland Clinic physician Tom Gildea developed the stents to keep open the airways of patients with serious breathing disorders caused by inflammation, trauma, tumors and other masses. Airway stents come in a limited number of sizes and shapes and are… […]
• Boston Scientific shares drop on Q4 sales news
  Shares in Boston Scientific (NYSE:BSX) dropped 8% this morning on news of disappointing fourth-quarter sales. The company’s preliminary earnings report showed sales for the quarter ended Dec. 31, 2019 coming in at $2.9 billion, below the $2.91 billion that analysts were expecting. The unaudited sales figure represents organic growth of 7.3%, missing the company’s own guidance of… […]
• Study: Timing for knee replacement surgeries is off
  New research from Northwestern Medicine suggests that patients with knee osteoarthritis are having knee surgery at the wrong time. According to the researchers, 90% of patients who could benefit from knee replacement surgery are waiting too long to have it and 25% of patients who don’t need it are having it prematurely. “People are waiting… […]
• TransEnterix wants to use more AI in surgical robotics: Here’s how
  TransEnterix (NYSE:TRXC) has filed a 510(k) submission to add an artificial intelligence feature to its robot-assisted surgery system in which the system can automatically move the camera for a surgeon. Surgeons have been able to move the camera on TransEnterix’s Senhance System via eye sensing. But the new Intelligent Surgical Unit would allow a surgeon, for… […]
• Diversified Plastics names Kieval to board
  Diversified Plastics, a custom plastic-injection molder and digital thermoplastic components manufacturer, said today that it has appointed Robert Kieval to its board of directors. Kieval has more than 25 years of experience at all levels of the medtech industry. The CEO of IMMR, Inc., Kieval previously served as chief scientific and clinical officer at women’s… […]