• FDA Issues Draft Guidance to Clarify UDI Form, Content

    New draft guidance issued by FDA provides information to help labelers and issuing agencies ensure unique device identifiers contain the right information and present it in the right format. Qmed StaffThere has been much uncertainty as the medical device industry shifts to FDA’s Unique Device Identification rule, and today the agency released draft guidance intended to clear the air regarding two aspects of the rule: the form and content of the Unique Device Identifier. Don't miss the...
  • Stryker Reprocessing Facility Hit with Class I Recall

    Stryker Sustainability Solutions is recalling angiographic catheters that could break off inside patients, causing injury or death.Nancy CrottiA Stryker medical device reprocessing facility is recalling unused catheters with either incorrect or nonexistent expiration dates because their tips might break inside a patient, causing injury or death.Don't miss the MD&M Minneapolis conference and expo September 21 & 22, 2016.Customers were notified June 1, 2016, to return the resterilized...
  • Olympus Execs Discouraged Early Warning on Problem Scopes

    Emails show that Olympus Corp. executives told employees it wasn’t necessary to inform U.S. hospitals when problems related to contaminated duodenoscopes initially came to light in Europe.Nancy CrottiOlympus Corp. executives based in Japan told U.S. employees not to warn hospitals in the United States about contaminated scopes that led to superbug outbreaks in Europe, according to a Kaiser Health News report.Don't miss the MD&M Minneapolis conference and expo September 21 & 22, 2016....
  • Smart Threads for Data Sharing

        Researchers from UC Berkeley have developed a way to coat the threading of clothing with thermochromic paint that can change colors to represent data and information, including health data. It could provide another tool for designers of mobile health devices. (Read the full Qmed story.)Read About 10 More Promising Medical Technologies>>[Image courtesy of UC Berkeley]
  • Enabling the Paralyzed to Once Again Move Limbs

        NeuroLife technology developed at Ohio State University and Battelle enabled a paralyzed young man, Ian Burkhart, to once again move his wrist and hand, and complete tasks such as strumming a guitar and swiping a credit card. It's all thanks to a chip implanted in his brain and machine-learning algorithms that decode the signals. The chip is connected to a port in the skull via a wire, with the cable delivering the information to a computer. The computer then uses...
  • Preventing Heart Attacks With an Electromechanical Hug

        Korean researchers recently demonstrated how wire wrap could stop rapid heart beat and restore cardiac electrical function for a rat's heart. The shape-conforming mesh is constructed of silver nanowires embedded in a rubber polymer. It was designed to conform to different hearts' unique anatomy. (Read the full Qmed story.) Other researchers including the flexible electronics pioneer John Rogers at the University of Illinois at Urbana-Champaign have also been working...
  • A Swimming Robot Powered by Heart Cells

        A Harvard University professor wants build a human heart, so he started out making a “living” stingray robot—about the size of a nickel and powered by rat cells. The small robot is even able to maneuver around obstacle courses with beams of light. So how could this lead to a robo-heart? Researchers said the stingray robot represents a "“a first step in engineering multilevel systems that link neurodynamics, mechanics, and complex controllable gaits—coupling sensory...
  • Changing the Way Drugs Are Prescribed

         OneOme (Minneapolis) provides patients with a pharmacogenomic test that then informs their health providers via an algorithm-based clinical decision support, helping the health providers to tailor prescriptions to exactly fit patients' needs. The decision support covers 340 medications for more than 20 medical indications. And it has a better chance of succeeding because it came out of a healthcare environment, co-developed and exclusively licensed...
  • 5 More Medical Technologies to Watch

        Prescription drugs customized through genetic testing and a brain implant that enables people with paralysis to regain movement in their limbs are among the additional medical technologies we’ve come across since posting our original list of the 10 most promising medical technologies of 2016.Read on to find out about more promising medical technologies.Continue >>Don't miss the MD&M Minneapolis conference and expo, September 21–22, 2016.Chris Newmarker is senior...
  • This Small Device Could Boost Lung Research

    Los Alamos National Laboratory scientists tissue-engineered an artificial lung into a small plastic microfluidic device, creating an opportunity to test human lung response to drugs, toxins, and other conditions.Kristopher SturgisResearchers from Los Alamos National Laboratory (LANL) nicknamed the plastic artificial lung “PuLMo” for pulmonary lung model. Much like the human lung, the technology consists of two major parts: the bronchiolar unit and the alveolar unit. The unit was designed to...
  • J&J Settles Acclarent Case for $18 Million

    The settlement comes just days after the former executives who ran Acclarent were convicted of misdemeanor charges related to alleged off-label marketing of sinus balloon catheters.Chris NewmarkerThis image was pulled from a 2011 clinical study describing the The MicroFlow spacer as "A Drug-Eluting Stent for the Ethmoid Sinus." The image shows the device's reservoir and shaft in "A" and the reservoir's features in "B."Johnson & Johnson Acclarent subsidiary will pay $18 million to...
  • Could 'The Doctor' Become Reality?

        The television series Star Trek: Voyager included "The Doctor," an Emergency Medical Hologram (EMH) that ended up having to become the fulltime doctor on the ship.While artificial intelligence isn't going to replace doctors any time soon, it could increasingly aid them with research and analysis. There is growing evidence that artificial intelligence can truly help health providers spot signs of illness in patients, including such deadly maladies as cancer.On a...
  • Scanadu

         Scanadu, a Silicon Valley medtech company, has been one of the most well-known of the Qualcomm Tricorder XPRIZE finalists, with its investigational Scanadu Scout device that has shipped to study participants and Indiegogo backers. Scanadu has now joined forces with one of the other competition finalists, Intelesens (formerly Zensor), which is led by Jim McLaughlin, director of NIBEC at Ulster University in Northern Ireland in the U.K.Continue >>
  • The GE Device That Makes Its Users Feel Like Captain Kirk

         Remember that time so long ago, about 10 years ago, when flip phones were cool? The design of the communicators in Star Trek helped out with that. Even the mobile phone's inventor Martin Cooper once said the series provided inspiration for the first mobile phone in 1973. GE Healthcare must like the flip design, too. Its pocket-sized Vscan ultrasound machine looks a lot like a Star Trek communicator. Continue >>[Image courtesy of GE Healthcare]
  • Recreating the Sickbay

        Wouldn't it be neat to have a Star Trek-style sickbay including a medical bed and overhead scanner with diagnostics? Researchers at the University of Leicester were inspired enough by the concept that they created a diagnostic bed utilizing thermal imaging equipment designed by space scientists. The idea was to detect blood chemistry problems without taking a blood sample.  “We are replacing doctors’ eyes with state-of-the-art imaging systems, replacing the nose with...
  • Hypospray Equals Jet Injector

         In the Star Trek universe, the hypospray was able to get medications into patients  through their skin, even their clothes, without using needles. In real life, this device was the jet injector, which never really became widespread because of concerns over cross-contamination, since even the tiniest particles of blood retained in such devices could include viruses. Development of new and improved jet injectors continues, though. Shown above is an illustration...
  • Nanoprobes

        Nanoprobes are generally positive things in medical device research circles. Google in 2014 mentioned the idea of nanoparticles that would be coated with a disease-detecting substance and possibly packed into a pill. Pioneering Scripps Health cardiologist Eric Topol, MD, has been working on blood stream nano sensor chips that could detect heart attacks. Self-reproducing medical nano robots inside the body could one day act as a "personal virus scanner" to fight germs and...
  • 3-D Printing

        3-D printing is quickly coming into its own in the medical device industry as a tool for both customized tools and implants. Johnson & Johnson has exclusive 3-D printing partnerships with both Hewlett Packard and high-speed 3-D printing company Carbon. And Stryker is creating a 3-D printing plant in Ireland. Including it in a list of Star Trek-related technologies might cause someone to say, "Huh?" But think about it. In a rudimentary way, 3-D printing is doing...
  • Making Geordi's VISOR a Reality

        Geordi La Forge in Star Trek: The Next Generation has been blind since birth, but uses a device called a VISOR to "see" the environment around him. The VISOR is able to scan an electromagnetic spectrum much wider than what human beings are normally able to perceive, and then transmits the visual data through an implant to the optic nerves.Second Sight Medical Products (Sylmar, CA), in fact, has its Argus II Retinal Prosthesis System. The Argus II is able to identify...
  • Surgery Without a Knife

        In Star Trek IV—which sends the original Star Trek cast back to 1980s San Francisco—Dr. Leonard McCoy at one point tells hospital surgeons to put away their knives so that he can repair a broken artery inside Pavel Chekov's head with an electronic gizmo. Direct energy surgery, in fact, is becoming more of a reality all the time. Focused ultrasound or some other form of energy could be concentrated to seal an internal wound or ruptured blood vessel or zap a tiny...