From Medical Design & Outsourcing

• RSNA 2019: 7 radiology innovations you need to know
  Nearly 53,000 people attended the 2019 Radiological Society of North America annual meeting in Chicago last week. And they heard the same acronym over and over again: AI. Exhibitors at the conference touted their artificial-intelligence-enhanced technology at every turn, claiming to make images clearer, sharper, easier to use and powerful enough to help clinicians make… […]
• Employees say Intuitive Surgical, J&J, Stryker best places to work in 2020
  Intuitive Surgical (NSDQ:ISRG), Johnson & Johnson (NYSE:JNJ) and Stryker (NYSE:SYK) were recently named as Glassdoor’s employees’s choice of Best Places to Work in 2020. Each year, Glassdoor uses feedback that employees have shared on the website over the past year to compile a list of the best places to work in 2020. Employee reviews provide Glassdoor with insights into job and… […]
• Biolase lands 510(k) for dental hygiene laser
  Biolase (NSDQ:BIOL) this week announced it has received FDA 510(k) clearance for its Epic Hygiene dental laser. The laser system allows dental hygienists to manage non-surgical periodontitis and increase clinical production. It offers a step-by-step clinical protocol with pocket therapy and perio debridement for easy implementation. Get the full story on our sister site, MassDevice. The […]
• Mayo Clinic, W.L. Gore team up on stem cell therapy treatments
  Mayo Clinic and W. L. Gore & Associates have announced a partnership to develop implantable cell therapies to treat debilitating conditions with no cure. The for-profit company, Avobis Bio, will combine a patient’s own stem cells with bioabsorbable scaffolds to stimulate the healing of perianal fistulas, painful tunneling wounds that affect patients with Crohn’s disease.… […]
• Toray Industries touts polymer optical fiber
  Toray Industries said today that its Raytela polymer optical fiber provides for high-quality imaging in the minimally invasive medical device market. Raytela can negotiate tight 9mm radius bends, making it useful for devices used in endoscopy, uretroscopy, ophthalmic surgery and other procedures that require smaller devices that can navigate more tortuous paths than previously available,… […]
• Report: EtO blood levels higher in Illinois neighbors of Medline sterilization plant
  This article has been updated with comments from Medline Industries. People who live about a mile away from a Medline device sterilization plant in Waukegan, Ill. have blood levels of the cancer-causing gas ethylene oxide that are about 50% higher than those who live farther away, according to a report by WebMD and Georgia Health… […]
• Glooko gains ISO certification for California, Sweden sites
  Diabetes software company Glooko announced today that its Mountain View, Calif., and Gothenburg, Sweden, sites have received joint ISO 13485:2016 certification from accredited certification body Intertek Testing Services. ISO 13485 describes the requirements for comprehensive practices and procedures for the design, development, production and delivery of medical devices, including digital health software. To become ISO… […]
• FDA details framework for abbreviated 510(k) medical device review pathway
  By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published a high-level framework for its Safety and Performance Based Pathway, an expedited 510(k) premarket review process for qualifying medical devices announced earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are… […]
• Drug or device? FDA loses this argument for now
  This article has been updated with comments from an attorney for Genus Medical Technologies. A federal judge has temporarily blocked an attempt by the FDA to regulate a barium sulfate product ingested before imaging as a drug. The decision counts as at least a partial win for Genus Medical Technologies (St. Louis), maker of the… […]
• Greenlight Guru updates change management capabilities of QMS
  Greenlight Guru said today that it has added updates to the change management capabilities 
of its medical device quality management system (MDQMS). The update was designed to improve traceability and efficiency associated with product and process changes, according to the Indianapolis-based company. It includes advanced workflow efficiencies to identify, assess and track the items affected… […]
• Medical device excise tax would reduce R&D spending, report says
  The medical device excise tax will reduce research and development spending and impede innovation if reinstated in 2020, according to a report from Minnesota trade group Medical Alley Association. In the report, Medical Alley surveyed its members that will be affected by the return of the tax on Jan. 1, 2020. About 83% of survey respondents… […]