From Medical Design & Outsourcing

• Endolumik’s illuminated device takes a big step for safety
  Endolumik’s story started a few years ago as the FDA sounded the alarm over the risks of internal surgical staplers. In 2019, the federal agency warned healthcare providers that it had received more than 41,000 medical device reports (MDRs) related to surgical staplers and staples for internal use from 2011 to 2018. Those MDRs tallied… […]
• FDA updates medical device shortage list due to shipping delays and semiconductors
  Medical device shortages persist due to shipping delays and semiconductor availability, the FDA said last week in an update to its medical device shortage list. The updated medtech products in short supply include radiological devices, general plastic surgery devices, cardiac diagnostic and monitoring products, general ICU/ hospital products, specimen collection supplies and ventilators. Philips Invivo… […]
• SaMD development lessons from Cordio’s voice AI heart failure app
  Software as a medical device (SaMD) development requires a different approach than traditional medical devices in a few ways. Repeat after me: My dad is a big chef. Speaking that short sentence and a few others like it into a smartphone once a day helps identify deteriorating heart failure patients at risk of declining, Cordio… […]
• Four gastroenterology device innovations doctors need now
  Gastroenterology is a field ripe for medical device innovation, and medtech developers know that some of the best ideas come from practicing doctors. With that in mind, Medical Design & Outsourcing spoke with two gastroenterologists about what device innovations would help them better diagnose and treat gastrointestinal diseases. Dr. Aasma Shaukat is the director of… […]
• Formlabs launches new skin-safe 3D printing material for healthcare
  NEWS RELEASE: Formlabs Introduces TPU 90A Powder, The First Elastomer Material for Fuse Series 3D Printers Formlabs, the leading 3D printing company, is excited to announce its newest material for Fuse Series printers: TPU 90A Powder, a tough elastomer powder. This new material enables strong, functional, skin-safe parts with high tear strength and elongation. The strength and flexibility… […]
• March 2023 Issue: Incredible enabling technologies
   Stryker on steroids: How enabling technology will supercharge surgical robotics How Penumbra’s smart-sucking algorithms and catheters speed up clot removal What Abbott learned about COVID-19 and cardio devices Genascence believes gene therapy can transform the treatment of knee osteoarthritis What to expect in diabetes care in 2023 Incredible enabling technologies The FDA has cleared… […]
• Qosina opens new ISO Class 8 cleanroom
  NEWS RELEASE: Qosina Unveils New ISO Class 8 Cleanroom Qosina, a global supplier of OEM single-use components to the medical and bioprocess industries, has completed the construction of its new state-of-the-art cleanroom. This 1700-square-foot, ISO Class 8 cleanroom supports the expansion of Qosina’s pick and pack process, allows the company to increase capacity, and reduce… […]
• Leveraging biophysics to fight the most aggressive forms of cancer
  An innovative device harnesses the power of electric fields to disrupt solid tumor cell division. By Bill Doyle, Novocure For more than 20 years, Novocure has been at the forefront of innovation, pioneering biophysical cancer treatments. With the invention and development of Tumor Treating Fields therapy, Novocure is striving to extend survival in some of… […]
• BCI company Science is getting into the outsourcing business
  Brain-computer-interface (BCI) developer Science announced has launched a platform to enhance medical device manufacturing outsourcing. Science CEO Max Hodak previously co-founded Neuralink, Elon Musk’s venture into brain-computer interfaces (BCIs). He served as president at Neuralink until 2021. His new venture with Science includes new BCI technology that doesn’t require an in-skull implant. Last November, the… […]
• Glowing nanoparticles enhance at-home COVID-19 test sensitivity
  Researchers at the University of Houston are using glow-in-the-dark materials to enhance the sensitivity of rapid COVID-19 home diagnostics. The widely used lateral flow assay provides rapid results for diagnostics such as at-home COVID-19 or pregnancy tests. They also offer low costs and ease of operation. Test results on LFA diagnostics come through in colored… […]
• Sunrise Labs announces engineering and quality promotions
  NEWS RELEASE: Sunrise Labs Appoints New Leaders Sunrise Labs, a medical device product development firm with offices in New Hampshire and Massachusetts, marked major milestones in 2022 by celebrating their 30th anniversary, expanding their office presence to the Boston area, and growing to over 100 employees. In addition to the expansion and growth to better… […]