• 5 Reasons Why Medical Device Innovation Is So Tough

    Financial costs and regulations are reasons, but there’s much more, says medical device industry expert Bill Betten.Brian BuntzInnovation in medicine is generally incremental, says Bill Betten (pictured), director of business solutions at Devicix (Eden Prairie, MN).“You build around what has been done before. When people hear that statement, they sometimes say things like: ‘what about the implantable pacemaker? Surely that was not incremental?’ But you could argue that the pacemaker certainly...
  • Are Robotics Still The Future of Medicine?

    While robots have been hailed as a promising technology for the medical device industry for decades, their role is still uncertain. We weigh the pros and cons of robotics in medicine.Kristopher SturgisPerhaps the most prominent example of robotics used in clinical care is Intuitive Surgical’s da Vinci, which is a promise and perils of robots in medicine. While the roughly $2-million robot can offer superhuman dexterity, it has also been linked to a “nonnegligible number of technical...
  • Scientists Make Lifelike Skin in the Lab

    This artificial skin is capable of sweating and growing hair.  Qmed Staff   Scientists have been making artificial skin for decades but the functionality of much it has been limited. Now, Japanese scientists have made sophisticated artificial skin using reprogrammed iPS cells that includes hair follicles and sebaceous glands. The researchers then implanted tissue samples in mice and reported that it was able to integrate with surrounding organ systems including nerves...
  • Theranos Test Results Are Erratic: CMS

    The bad news keeps continues to pile up for next-gen blood-testing firm Theranos. According to recently released CMS documents, the company’s technology failed 29% of its quality-control checks in October 2014. According to the reports, quality problems were commonplace based on analyses performed in July 2014 and from February 2015 to June 2015.Qmed StaffA CMS report found that the company’s Edison technology—designed to test small amounts of blood from a fingerprick—failed 87% of quality-...
  • How Genetically Engineered Maggots Could Heal Wounds

    Research out of North Carolina State University shows that genetically engineered green bottle fly larvae secrete a human growth factor that could be used to promote cell growth and heal wounds.Kristopher SturgisThe recent proof-of-concept study was aimed at creating a new strain of genetically engineered green bottle fly (Lucilia sericata) larvae with enhanced wound-healing effects through the secretion of a human platelet–derived growth factor (PDGF-BB) that is known to stimulate cell growth...
  • Researchers Find 1400 Software Vulnerabilities in Medical Supply System

    Independent researchers have uncovered 1418 third-party software vulnerabilities in outdated but still used automated supply cabinet used to dispense medical supplies, according to a federal cybersecurity advisory.Nancy CrottiSecurity researchers found vulnerabilities in end-of-life versions of CareFusion’s Pyxis SupplyStation system. Collaborating with CareFusion, researchers Billy Rios and Mike Ahmadi identified the vulnerabilities in end-of-life versions of...
  • Former Abbott Exec Hopes to Stay Insider-Trading Trial

    James Mazzo and his lawyers are arguing that a pending Supreme Court decision could set a precedent that would lessen the severity of the case against him.Nancy CrottiFormer Advanced Medical Optics CEO James Mazzo has asked for a stay in his insider trading trial, pending a decision by the U.S. Supreme Court that could set a potential legal precedent in Mazzo’s case.Mazzo’s trial is scheduled to start July 19 in U.S. District Court for the Central District of California in Santa Ana. The...
  • Origami Is Inspiring Minimally Invasive Surgical Advances

    The traditional Japanese paper-folding art form has helped drive breakthroughs in everything from battery technology to foldable solar panels used in space. Now, it could be driving advances in robotic surgery.Brian BuntzResearchers at Brigham Young University (BYU; Provo, UT) have been working with NASA to use origami principles in spacecraft design. “Those who design spacecraft want their products to be small and compact because space is at a premium on a spaceship, but once you get in space...
  • More Questions about Accuracy of Theranos Tests

    Theranos, already under fire from regulatory authorities at CMS and FDA, is facing renewed allegations that its blood-testing technology is inaccurate.Qmed StaffElizabeth Holmes is the CEO of Theranos. A recent study published in the Journal of Clinical Investigation (JCI) found that the company’s fingertip-blood-testing technology could not match the accuracy of more conventional tests from LabCorp or Quest. “Theranos flagged tests outside their normal range 1.6× more often than other...
  • How Frog Foam Can Deliver Antibiotics

    Scientists discover a foamy substance made by Trinidadian frogs that could provide a non-toxic antibiotic delivery system, which could help treat and prevent the spread of infections.Kristopher SturgisThe discovery was presented at the Microbiology Society’s annual conference in Liverpool last week, detailing a substance that Tungara frogs (Engystomops pustulosus) produce while mating that contains protein that they beat into a foamy substance with their back legs. The frogs then use this foam...
  • Wearable Defib Vest Shows Promise, Says AHA

     The wearable cardiac defibrillator vest may be a good option for patients who cannot tolerate an implant. Nancy Crotti The American Heart Association, based on more than 100 studies of patients using the LifeVest Wearable Cardioverter Defibrillator. The group published an advisory in its journal, Circulation, its first on the devices. Zoll Manufacturing of Pittsburgh, PA, makes the only defib vests on the market, for use by adults and children, but there are other devices...
  • Lawsuit Claims Medical Device Caused Brain Damage

    A Washington man is filing a suit against a California company for making an implant that he said malfunctioned.Qmed StaffThe software developer is suing Penumbra Inc. because he says that the company’s Penumbra Coil 400 device caused brain damage. After suffering an aneurysm in 2013, Dennis Montgomery was treated with the device. When the device was placed into the aneurysm, 10% remained stuck in the intracranial artery. According to Montgomery’s attorney, Peter Mullenix, the device...
  • Nanowire Discovery Could Lead to Enhanced Nanoelectronics

    A new microbial protein fiber discovered by researchers at Michigan State University contains unique properties that can transport charges at speeds of 1 billion electrons per second.Kristopher SturgisThe discovery came from a group study of a specific bacteria called Geobacter, a name of Latin origin that translates to “battery from earth.” These bacteria contain a remarkable ability to respire minerals, meaning they breathe rust. Gemma Reguera, associate professor of microbiology and...
  • Google's Healthcare Biz Sees Employee Exodus

    Roughly a dozen employees in Google’s secretive healthcare division have left the company in the past year, according to STAT.Qmed StaffWhile Google’s secretive new healthcare division Verily has made headlines because of its bold technological vision, a considerable number of employees are leaving the company. According to STAT, many are stating that is challenging to work for the company’s CEO, Andrew Conrad, who had previously been the chief scientific officer of Laboratory Corporation of...
  • Abbott Could Face $1B Whistleblower Fine

    Abbott Laboratories could face a $1 billion fine in a federal whistle-blower lawsuit over off-label use of stents, and allegations of Medicare fraud and kickbacks paid to hospitals and physicians for such use.Nancy CrottiThe jury trial began this week in U.S. District Court for the Northern District of Texas in Dallas, 10 years after former Abbott and Guidant sales representative Kevin Colquitt brought the allegations. Illinois-based Abbott obtained Guidant Corp.’s vascular business in a...
  • How Plasma-Based Printing Can Join Nanomaterials to Flexible Surfaces

    A new way to print nanomaterials onto 3-D objects and flexible textile materials could have an array of applications, including biosensors, batteries, and integrated circuitry.Kristopher Sturgis“Printing nanomaterials, especially sensors and electronic materials on 3-D objects can be a game changer in additive manufacturing,” Gandhiraman says.The technique could make it much simpler and cheaper to produce devices made from nanomaterials like wearable biosensors, batteries, integrated circuitry...
  • Terumo Gets FDA Warning Letter

    Terumo (Tokyo) was hit with a FDA warning letter relating to the manufacture of its renal, carotid and peripheral use are adulterated under the Federal Food, Drug, and Cosmetic Act.Qmed StaffThe FDA has sent a warning letter to Terumo Corp., warning the company about manufacturing and quality control deficiencies related to its Destination line of guiding vascular sheaths.The problems, which were outlined in the publicly available letter, specifically related to noncompliance of the company’s...
  • Philips to Pay $35 Million to Settle Medicare Fraud Charges

    The Respironics division of Philips has agreed to pay $34.8 million to settle allegations that it offered kickbacks to companies that bought its sleep apnea masks.  Brian Buntz Philips’ Murrysville, PA–based Respironics division was accused by the Department of Justice of offering free call center services to suppliers of durable equipment to sway them to buy their sleep apnea masks. The company has agreed to pay $34.8 million to resolve those charges without admitting guilt. The...
  • How Plasma Can Print Nanomaterials on Flexible Surfaces

    A new way to print nanomaterials onto 3-D objects and flexible textile materials could have an array of applications, including biosensors, batteries, and integrated circuitry.Kristopher Sturgis“Printing nanomaterials, especially sensors and electronic materials on 3-D objects can be a game changer in additive manufacturing,”declares Ram Prasad Gandhiraman, a research scientist at Nasa Ames Research Center (Mountain View, CA).The technique could ultimately make it simpler and cheaper to produce...
  • Medical Devices May Have Been Stolen from Military Facility

    The federal government is investigating whether a federal employee took medical equipment from a naval facility in Bethesda, MD, and attempted to sell them online, according to a report by NBC News.Nancy CrottiAt least $18,000 worth of medical “dummies,” tubing devices and electronics were reported stolen in December from the Naval Support Activities Washington complex, the oldest naval installation in the United States. In an affidavit, the agent reported finding some of the missing items...