FDA sets date for advisory panel meeting on breast implants

From Medical Design & Outsourcing

• 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  FDA has issued draft guidance providing for more timely nonbinding feedback following medtech facility inspections to advise whether the companies’ proposed corrective actions appear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 The draft guidance proposes a process by which companies can request nonbinding feedback on certain kinds of observations issued on a Form 483.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… […]
• Affluent Medical touts results of endovascular aneurysm repair study
  Medtech startup Affluent Medical(Paris, France) said a study of its endovascular aneurysm repair (EVAR) system device showed patients had fewer endoleaks and needed fewer secondary interventions, and that their aneurysms shrank in volume and diameter. The company’s Kardiozis endovascular prosthesis uses thrombogenic fibers to embolize an abdominal aortic aneurism sac during a conventional EVAR procedure to prevent… […]
• This cotton-based biofuel cell could power implanted medical devices
  Researchers at the Georgia Institute of Technology and Korea University have developed a glucose-powered biofuel cell that uses electrodes from cotton that could potentially power implantable medical devices. The fuel cell has twice as much power as traditional biofuel cells and could also be paired with batteries or super capacitors to create a hybrid power… […]
• IEEE publishes safety standards draft for medtech interoperability
  The Institute of Electrical and Electronics Engineers (IEEE) Standards Association said it has published a draft set of standards intended to provide safe and secure medical device interoperability. IEEE 11073-20701-2018, also known as IEEE Approved Draft Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding, completes the International Organization for Standardization (ISO)/IEEE 11073 family of standards… […]
• FDA clears Safe Medical Design’s urethral catheter
  Safe Medical Design (San Francisco) said that FDA has cleared its Signal Catheter for commercialization in the United States. The 100% silicone foley catheter features a novel hub design allowing the catheter to reduce excessive balloon pressure in the event the catheter is improperly placed. Each year in the United States there are as many as 500,000… […]
• These medtech companies raised the most VC in 2018
  Venture capital firms invested more than $2.9 billion in medical device companies in 2018 — a slight increase from the $2.8 billion raised in 2017, according to the MoneyTree report from PricewaterhouseCoopers (PwC) and CB Insights. Both the first and second quarters of 2018 saw an increase in investments, totaling nearly $778 million and $786 million respectively.… […]