Abiomed shares sink as FDA votes to keep Impella pump at highest risk level

From Medical Design & Outsourcing

• How to ensure adhesion on hard-to-bond plastic substrates
  Medical device companies are increasingly using plastic substrates that are tough and sterilization/chemical resistant. But they also come with adhesion challenges. Michelle Gumbert and Patrick Vaughn, Dymax  For medical devices such as catheters, prefilled syringes, vials, test tubes and injector pens, many manufacturers are turning to plastic substrates that are specifically formulated to resist harsh […]
• UDI laser marking: Here’s the key to making it durable
  Optimized lasers and passivation can make the difference when it comes to creating durable UDI laser markings for medical devices, according to a new long-term case study. Tuttlingen, Germany–based Add’n Solutions, worked with FOBA Laser Marking+Engraving to test the marking processes. The results found that FOBA’s short pulse fiber making lasers worked better when optimized to adapt to […]
• 3D printed living tissue may eliminate animal testing
  English scientists have figured out a way to 3D print cells grown in a laboratory to create living structures. Researchers at the University of Oxford and the Center for Molecular Medicine at Bristol were able to showcase how human and animal cells could be printed into high-resolution tissue constructs. Being able to control the position […]
• 7 diagnostic devices to boost healthcare in the developing world
  The World Health Organization estimates that a quarter of death and disease globally is caused by hazards and environmental burdens in developing countries with little to no access to preventative care and diagnostic devices. Since developing countries are poor agricultural regions that are still becoming economically and socially advanced, it is harder for doctors to […]
• Is there a digital health solution for treating pain?
  Could TENS devices be a potential answer to the opioid crisis? If they are, it’ll be thanks to digital health. Case in point is NeuroMetrix’s Quell device. Transcutaneous electrical nerve stimulation (TENS) gizmos have been around for decades. But they’ve had a reputation for being unwieldy, with a bunch of wires and pads. “TENS devices have been around […]
• FDA pre-certification for software program: key questions and eligibility requirements
  Stewart Eisenhart, Emergo Group Following the rollout of a pre-certification pilot program for digital health technology and software developers, the U.S. Food and Drug Administration has identified and answered several frequently asked questions regarding participation. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
• FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device
  Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension. MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there. Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed […]
• How Consensus Orthopedics added smarts to orthopedic devices
  Consensus Orthopedics made headlines with its TracPatch this year. So how did an ortho company get a digital product to market? Let’s face it, orthopedic devices are dumb. That is to say, they are mute. Silent. And in today’s healthcare environment, the silent kind of dumb is dangerous. Consensus Orthopedics (El Dorado Hills, Calif.) wanted to […]
• Allergan gel-based stents are treating glaucoma
  An Allergan-developed gelatin-based stent is showing potential to treat glaucoma in a quicker and safer environment, according to new research from the University of Michigan. Glaucoma is a disease that damages the eye’s optic nerve and can cause vision loss and blindness. Medicines in the form of eyedrops or pills can be used to treat […]
• This spit-powered battery could expand diagnostics in developing countries
  A new battery developed by Binghamton University can be activated using spit and used in places where normal batteries can’t be used. Binghamton University electrical and computer science assistant professor Seokheun Choi has spent the last five years developing micro-power sources that can be used in resource-limited regions for diagnostic biosensors. Choi has previously developed […]
• How glass-sealed connectors increase medical device longevity
  As medical instruments and technologies grow more sophisticated and complex, it is increasingly important to guard sensitive components from the autoclaving process while supporting their longevity. Glass offers a solution. Jochen Herzberg, Schott Electronic Packaging In today’s era of rapid technological advancement, medical devices have become more complex and capable than ever thanks to the […]