Emergo Podcast: ANVISA medical device approval in Brazil

From Medical Design & Outsourcing

• Summit Medical expands manufacturing facility
  Summit Medical recently announced that it has expanded its St. Paul, Minn. manufacturing facility with an additional 15,000 sq. ft. The addition opened on Feb. 11. The expansion will become a secondary facility for the company’s headquarters that is located less than a mile away. It will also serve as a master distribution center. “The… […]
• AdvaMed president & CEO Scott Whitaker to participate in keynote interview at DeviceTalks Boston 2019
  WTWH Media and MassDevice.com announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices… […]
• Apollo Endosurgery touts results of stomach-stapling study
    Apollo Endosurgery (NSDQ:APEN) has reported key data from 1,000 patients who underwent endoscopic gastroplasty using the company’s OverStitch device. Published in the journal Gastrointestinal Endoscopy, the data include a mean total weight loss of 14.8%±8.5% at 18 months. Three months following surgery, the impact on obesity-related comorbidities included the complete remission of: 13 of 17 cases… […]
• Royal Philips introduces new C-arm imaging tech
  Royal Philips (NYSE:PHG) said it has launched a new mobile C-arm imaging platform, Zenition. Mobile C-arms are X-ray systems that are brought into the operating room (OR) to provide live image guidance during a wide range of surgeries including orthopedic, trauma and vascular procedures. The Zenition mobile C-arm platform brings together innovations in image capture, image… […]
• When human factor specialists become the patient
  By Allison Strochlic, Emergo Group I just had a baby – my second daughter. This means that, like over 98% of my fellow American moms-to-be, I checked into a local hospital to have nurses and doctors oversee what I hoped would be the smooth delivery of my baby. This entitled me to the firsthand experience… […]
• Medtronic risk prediction tool could help prevent opioid deaths: Here’s how
  Medtronic officials continue to hone their arguments for how the company’s capnography and oximetry systems could reduce potentially deadly opioid-induced respiratory compromise. The medical device giant on Feb. 17 announced preliminary results of its Prodigy study, in which the company’s Microstream and Nellcor monitoring technology provided continuous capnography and oximetry for 1,496 patients across 16 sites in the U.S.,… […]
• Phillips-Medisize is expanding in Wisconsin
  Phillips-Medisize, a Molex company, has broken ground on a new manufacturing facility in Hudson, Wis., on the eastern end of the Minneapolis-St. Paul metro area. The 34-acre location at the St. Croix Meadows development will support at least 230,000 square feet of manufacturing space for FDA-regulated medical device products, Phillips-Medisize announced yesterday. After construction is complete… […]
• ReWalk Robotics files for exoskeleton suit clearance
    ReWalk Robotics (NSDQ:RWLK) said it has applied to FDA for 510(k) clearance of its ReStore exoskeleton suit for gait training during stroke rehabilitation. The Yokneam, Israel-based company designed its exo-suit to provide coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. It recently won insurer reimbursement from Cigna and completed a clinical… […]
• FDA proposes faster post-inspection feedback
  FDA has issued draft guidance providing for more timely nonbinding feedback following medtech facility inspections to advise whether the companies’ proposed corrective actions appear adequate to the agency. The draft guidance proposes a process by which companies can request nonbinding feedback on certain kinds of observations issued on a Form 483. It outlines a standardized method… […]
• India CDSCO adds new medical devices to regulated list
  By Stewart Eisenhart, Emergo Group India’s Central Drugs Standard Control Organization (CDSCO) continues expanding oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s… […]
• Empowering Medical Innovation
  From faster medical device development to life-saving surgical planning models, see how full-color, multi-material 3D printing opens up broad possibilities for medical innovation. In this new E-book you’ll learn how the Stratasys J750 can: Produce superior medical models for surgical planning and training Foster better medical devices through faster ideation and prototyping Enable advanced training… […]