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From Medical Design & Outsourcing

• 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 […]
• Manufacturing drug device products: challenges and best practices
  Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical […]
• Abbott’s new contact ablation catheter: Here’s what you need to know
  The new TactiCath contact ablation catheter unites EndoSense and St. Jude Medical technologies that Abbott acquired, marrying fiber optics, flexibility and 3D mapping. If you want your grilled cheese to cook faster, you press it into the pan with your spatula. That’s contact force, the principle behind Abbott’s TactiCath contact force ablation catheter, according to […]
• Medical device regulation: How it’s changing in the U.S. and Europe
  Mary Beth Ritchey, RTI Health Solutions This is a busy year for medical device regulation in the United States and Europe. U.S. medical device regulation legislation In the U.S., the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) is due to expire Sept. 30. A new bill including updates for medical devices has […]
• Magnetic fields can destroy biofilms on implants: Here’s how
  Alternating magnetic fields may be the key to fighting bacteria that grows on artificial joints, according to new research from the University of Texas Southwestern. Researchers at UT Southwestern claim that short exposure to high-frequency alternating magnetic fields (AMF) has the potential to destroy bacteria that ends up in biofilms growing on the surface of […]
• How a common hospital tool predicts poor outcomes after liver transplants
  A frequently used tool in the hospital can be an indicator of which liver transplant recipients will do poorly after surgery, according to new research from Cedars-Sinai Medical Center. Led by Vinay Sundaram, a team of researchers found that the nursing assessment called the Braden Scale could be put to use in liver transplant patients […]
• Medtech stories we missed this week: August 11, 2017
  From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions […]