FSS lands extended CE Mark for FlexStent | Regulatory Roundup

From Medical Design & Outsourcing

• DeviceTalks Tuesdays: Creativity in Engineering Design: Things I Was Never Taught In Engineering School
  Tuesday, Oct. 27, 2020 4 pm Eastern Tim/ 1 pm Pacific Time Engineering is an act of creation – a lot of folks get into this line of work explicitly because they want to create. In this webinar, speakers will talk about the light bulb moments of lone inspiration, and the more practical group efforts.… […]
• Acuitive Technologies wins FDA clearance for tendon interference screw system
  Acuitive Technologies announced today that it received FDA 510(k) clearance for its CitreLock interference screw system. CitreLock with CitreGen material technology, a next-generation thermoset bioresorbable synthetic polymer, is designed to attach tissue during orthopedic surgeries, including the fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee and foot extremities,… […]
• Medovate lands distro deal with major French medtech company
  Medtech manufacturer Vygon Group recently announced that it will distribute Medovate’s SAFIRA (SAFer Injection for Regional Anaesthesia) device across 60 countries. Developed in collaboration with UK National Health Service clinicians, SAFIRA is designed to transform the technique of peripheral nerve blockade into a one-person procedure, giving the anaesthetist full control of the injection at all… […]
• How spider webs could inspire better biomedical imaging
  Researchers at Purdue University are today touting the use of architectural features from spider webs in biomedical imaging. As spider webs usually provide strong mechanical adaptability and damage-tolerance against various mechanical loads, such as storms, they are coming in handy in the development of 3D photodetectors for use in biomedical imaging, according to a news… […]
• DTW Podcast: Who will win medtech’s own Supreme Court fight; and can the many mini Medtronics plan work?
  In this week’s DeviceTalks Weekly podcast, we’ll first delve into Medtech’s own brewing Supreme Court battle. J. Michael Jakes, a partner at Finnegan, will tell us why the industry should be watching when the Supremes review the latest patent battle between Arthrex and Smith+Nephew. We’ll also talk about Medtronic’s Analyst Meeting where CEO Geoff Martha and the team… […]
• Mahr adds sales, quality managers
  Mahr (Providence, R.I.) announced today that Josh Howlett has joined the company as Northeast regional sales manager, and Celina Ortiz has been appointed manager of quality assurance. Howlett has held sales management positions at Zeiss Industrial Metrology and HGH Infrared Systems, and most recently served as regional sales manager for Koma Precision. He studied Business… […]
• Advamed: Diagnostic COVID-19 tests shipments hit 200M
  Total U.S. shipments of COVID-19 molecular diagnostic tests have reached 200 million, according to AdvaMed’s COVID-19 diagnostic supply registry. A breakdown of the data shows that diagnostics companies are shipping, on average, more than 1.4 million molecular tests each day. “For the past few months, our diagnostics companies have made it clear they’ll do whatever… […]
• FundamentalVR expands into ophthalmology
  FundamentalVR today announced it is expanding its surgical specialty capabilities to include ophthalmology. The Boston-based company said it will use its HapticVRTM technology architecture, designed to mimic the physical cues of surgical actions, medical tools, and tissue variations, to create data-driven medical educational simulations for ophthalmology as well as orthopedic device and pharmaceutical brands. Fundamental… […]
• Enhancing the Reliability of Pregnancy Tests with High-Performing Wicks
  By Natalie Schlage, Strategic Marketing Manager – Diagnostics, Porex When it comes to life-changing tests, the accuracy of the results is non-negotiable. Every year millions of women rely on home pregnancy tests to deliver potentially life altering news. In fact, according to Statistica, 8.8 million women in the United States used a home pregnancy test… […]
• Bruker launches next-gen Fourier 80 benchtop spectrometer
  Bruker this week announced it launched its next-generation Fourier 80 benchtop spectrometer system. Fourier 80 is an 80 MHz Fourier Transform Nuclear Magnetic Resonance benchtop spectrometer that is equipped for gradient spectroscopy. It is designed for organic or medicinal chemistry analysis, NMR teaching, synthesis verification or routine analysis in a chemistry lab. The Fourier 80… […]
• Minnetronix lands NIH grant to study spinal fluid treatment tech
  Minnetronix Medical today announced that it has been awarded a National Institutes of Health (NIH) grant for continued study of its proprietary Neurapheresis cerebrospinal fluid treatment platform. Akin to hemodialysis, the Neurapheresis platform is designed to rapidly remove blood cells and their cytotoxic byproducts that are released into cerebrospinal fluid following an aneurysmal subarachnoid hemorrhage.… […]