Novaliq, AFT Pharmaceuticals ink licensing deal for NovaTears dry eye therapy

  • Medical device firms have little understanding of European MDR, IVDR

    By Stewart Eisenhart, Emergo Group Many medical device companies have yet to fully absorb the ramifications of the new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) for their compliance efforts, according to Emergo’s 2017 Global Medical Device Industry Outlook. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

  • Cybersecurity: Is medtech ‘lackadaisical’ about it?

    The medical device industry needs to shake itself out of its stupor when it comes to cybersecurity, according to James Scott, senior fellow at the Institute for Critical Infrastructure Technology and author of the new paper, How to Crush the Health Sector’s Ransomware Pandemic. Companies in the medtech sector and the overall healthcare space face […]

  • Fibrosis: How to prevent it in medical device implants

    Massachusetts Institute of Technology (MIT) and Boston Children’s Hospital researchers have discovered a way to prevent fibrosis from forming around medical device implants by blocking certain cells. The body’s immune system usually attacks implanted medical devices that are used for drug delivery, sensing or tissue regeneration. Defense cells in the body try to isolate the […]

  • These tiny jet engines could propel pharmaceuticals in the body

    Researchers at the Max Planck Institute for Intelligent Systems in Stuttgart, Germany are creating nanorobot propulsion systems that could help transport pharmaceutical agents in the body. Two types of propulsion systems were created. One was powered by bubbles that are oscillated by ultrasound, while the other one was powered by an enzymatic reaction that would […]

  • Malaysia plans to ratify ASEAN Medical Device Directive

    By Stewart Eisenhart, Emergo Group Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar attended by Emergo consultants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or […]

  • Micro-manufacturing: 5 things you need to know

    The health outcomes that minimally invasive surgical devices provide – shorter hospital stays and recovery periods – are as remarkable as the micro-manufacturing methods that produced the devices. Micro-manufacturing involves more than making conventional tooling smaller. Micro-extrusions and micro-molding also involve ultra-fine wires and electronic components. Helmbrechts, Germany-based Raumedic, which has its U.S. headquarters in […]

  • David R. Arguin named president of Helix Linear Technologies

    Helix Linear Technologies, a player in linear motion and factory automation industries, is pleased to announce that David R. Arguin has earned the promotion to president and member of the company’s executive team, reporting to CEO Christopher Nook. Arguin will have oversight of the strategic direction, expansion, and operation of the company. Arguin has helped […]

  • MedLumics secures 34.4M Euros in Series B funding

    MedLumics, a cardiac device company specializing in optically guided minimally invasive instruments, announced that it has raised 34.4M Euros in financing that will be used to help advance the product and clinical development of the company’s AblaView catheter, intended for the treatment of atrial fibrillation (AF) and other arrhythmias. This financing is the largest in […]

  • New CQI/IRCA-Certified lead auditor training based on ISO 13485 and International MDSAP

    NSF International, a global public health and safety organization, is now offering QMS Lead Auditor Training based on both ISO 13485:2016 and international Medical Device Single Audit Plan (MDSAP) requirements. The five-day training program is the first international MDSAP- and ISO-compliant medical device auditing course to be certified by the Chartered Quality Institute (CQI)/International Register of Certificated […]

  • Aerospace may have something to teach medtech about materials: Here’s how

    QuesTek Innovations has used advanced computer modeling to produce innovative materials in the aerospace sector. Now it’s looking to recreate the same magic in the medical device space. Chris Newmarker, Managing Editor Medical device developers typically turn to off-the-shelf materials and then design based on the properties of the materials. But does it have to […]

  • Failure to thrive: Lessons learned from medtech innovations that missed the mark

    Some of the medical device industry’s most heralded disruptors wound up being its biggest failures. Here’s what we can learn from their mistakes. Fink Densford, Associate Editor No one in medtech sets out to fail. No one invests in building a device believing that, despite years of research and development, it won’t make the cut. […]