Feds want more input on materials with ‘high-profile safety concerns’

From Medical Design & Outsourcing

• They said it at DeviceTalks Boston
  Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead. Here are some of the most quotable insights from panelists and speakers at our live event. And make sure to save the date — and save your seat… […]
• Summer health technology program brings diverse group of interns to Silicon Valley
  Diversity by Doing HealthTech (DxD) is holding a Summer Innovation and Exploration Series for college student interns from underrepresented groups. The series is on its second day today at Fogarty Innovation and Stanford Byers Center for Biodesign — the two organizations that jointly formed and support DxD. The event debuted last year in an online… […]
• Clippard releases new series of isolation valves
  Clippard (Cincinnati) has Its Clippard NIV Series media isolation valve — a solenoid-operated device using a flexible diaphragm to isolate the actuation mechanism from the fluid path. Media isolation valves find everyday use in a wide variety of applications. Think uses that require precise, repeatable dispensing of media for analytical instrumentation. Clippard says media isolation… […]
• Another Medtronic HVAD recall is serious
  A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients. The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this… […]
• How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
  SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff… […]
• How Avail Medsystems seeks to create a connected OR experience
  Much like a normal Starbucks-goer expects the coffee to taste a certain way at any location, Daniel Hawkins wants that type of experience in the operating room. Hawkins is the CEO of Avail Medsystems, a company developing telemedicine equipment that can connect surgeons, interventional specialists and medical device sales reps. Hawkins and the team at Avail… […]
• How to leverage technology to drive diversity in clinical studies
  Convenience was the driver, and the traditional clinical trial model had to evolve when it came to a colorectal cancer screening study. The clinical study had 35,000 patients across the U.S. Chuanbo Xu, Freenome Cancer doesn’t discriminate. It’s the second-leading cause of death in the U.S. Early detection is key in treating — and even… […]
• Medical device licensing pitfalls to avoid
  Prevent costly disputes caused by these common mistakes in patent license agreements. Marcelo Barros, Kathleen Daley, Brian Kacedon and Matthew Ritter, Finnegan Licensing and other technology transfer agreements can be critical for medical device companies that invest significantly into new technology R&D and seek and obtain intellectual property protection for those investments. But if these agreements… […]
• Tolerance stack-up: Insight into the inner workings of high-density microelectronic medical devices
  Tolerance stack-up is a defining design concept to ensure new products are built efficiently and effectively.  Darren Gilmer, Intricon At a time when the future of micro-miniature medical devices seems unlimited, one fundamental reality remains firmly in place — the sizes and shapes of human anatomy. From blood vessels to ear canals, respiratory passages to… […]
• Deburring and finishing for beautiful, functional medical devices
  The latest automated cutting tools help medical device manufacturers meet strict specs and high demand. Dave Sawicki, Xebec Increasing demand and advances in technology are driving growth in the medical device industry. Chronic diseases are more prevalent, and the aging population is larger, contributing to the demand for highly regulated Class III medical devices such… […]
• FDA seeking innovations to move beyond heater-cooler device problems
  The FDA issued a notice today saying that it is working to evaluate new strategies to mitigate infections associated with heater-cooler devices. According to the notice, the administration is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts on the matter surrounding the heater-cooler devices used during medical and surgical procedures to warm… […]