Novaliq’s NovaTears dry eye disease therapy launches in New Zealand

  • FDA launches new market pathway for breakthrough medical devices

    By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to establish a new market authorization pathway for innovative and breakthrough medical devices that would replace current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program. Get the full story here at the Emergo Group’s blog. The opinions […]

  • Enabling micro-sensors for next-gen interactive implants

    CerMet – an advanced ceramic and metal technology system – creates the potential for implantable devices with thousands of electrical channels. Think new options for treating blindness and neurological conditions. Only a few years old, Heraeus’ CerMet is upping the game when it comes to sophisticated implantable electronic devices. “Medical implants manufactured using the Heraeus CerMet […]

  • Clinical trials webinar: How you can connect the dots with staicy

    Tuesday, Nov. 28, 2017 11:30 a.m. Eastern time / 8:30 a.m. Pacific time     staicy is a next-generation health and research management platform which provides full transparency of your clinical data. Learn about integrating seamlessly your internal and external clinical applications and utilizing staicy’s proprietary functionality to uniquely select geographical storage location for your data. […]

  • Freudenberg Medical launches new hemostasis valves

    Freudenberg Medical has launched several new hemostasis valves for interventional and diagnostic catheters. HyperSeal and CertuSeal hemostasis valves have been added to the FlexSeal valve line that the company released last year. Freudenberg Medical also added its new HyperSeal Introducer Sheath with Hydrophilic Coating to the FlexSeal Introducer Sheath for large bore procedures. The catheters […]

  • Expanding design horizons with gas-assist molding

    Scott Rishell, Mack Molding Gas-assist molding, the process of using nitrogen gas pressure to fully form a part, increases design and manufacturing options for injection molded components. Traditional plastic processing brings design and manufacturing benefits through repeatable, high-volume and high-quality part production coupled with cost reductions, but its versatility can be expanded in certain scenarios […]

  • Why a global footprint is a medtech business imperative, not a buzzword

    Oscar Ford, Preh IMA Automation A global manufacturing footprint can help medical device companies capture value for their businesses by accessing talent and reducing costs. Here’s how to successfully execute this strategy without falling into a reactionary offshore initiative. In the last two decades there was an undeniable shift in the U.S. toward offshoring manufacturing […]

  • Patient with complete spinal cord injury regains voluntary motor function

    Patients who have lost mobility in their legs due to complete spinal cord injury could soon regain lost motor function below the level of injury, thanks to new research out of the University of Louisville. Motor function was recovered after study participants received long-term activity-based training and spinal cord epidural stimulation (scES). After approximately 34.5 […]

  • Insightec wins most innovative medical technology of 2017

    Insightec’s Exablate Neuro has won the Galien Foundation’s award for most innovative medical technology of 2017 at the 11th Annual Prix Galien USA Awards. The award ceremony took place on Oct. 26 at the American History Museum of Natural History in New York City. The Exablate Neuro is an ultrasound device that is FDA-approved to treat […]

  • Medtech stories we missed this week: Oct. 27, 2017

    From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows […]

  • The top 10 medical disruptors of 2018

    Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor is that it has to be so innovative that it could change healthcare in a significant way in the next year. Approximately 150 to 200 Cleveland Clinic physicians from […]

  • MINMAX announces new DC/DC converters

    MINMAX has announced its new MKW015M and MKW020M families of IEC/EN/ES 60601-1 Type BF approved medical DC/DC converters offering 15W and 20W of single/dual output power in the industry standard 1-by-2 inch footprint. Each of the MKW15M and MKW20M consist of 21 models offering input ranges of 9~18, 18~36, 36~75Vin and outputs of 5, 5.1, […]

  • 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. […]