• Dexcom Hit with Major Glucose Monitors Recall

    The recall involves hundreds of thousands of continuous glucose monitors with potentially faulty alarms.Dexcom won FDA approval last year for its Dexcom G5 mobile continuous glucose monitoring (CGM) system, which sends glucose data directly to a smartphone. (Image courtesy of Dexcom)Nancy CrottiDexcom has announced a massive and serious continuous glucose monitors recall, involving more than 260,000 devices with alarms that may fail to sound.Rather than asking customers to...
  • IBM Has Ambitious Plans to Decode Epilepsy

    The goal of the Australia-based research is to recognize epilepsy in brain scans of individual patients in the same way Facebook recognizes your face in photos.Nancy Crotti(Pixaby image of neurons courtesy of Gerd Altmann)IBM researchers in Australia are working on a way to stop seizures before they start, using computer software modeled on the web of neurons in the human brain, according to a report by Wired.Working with neurologists at the University of Melbourne, they’re...
  • Is an App Store for Surgery the Next Big Thing?

    Scott Huennekens, CEO of the joint Verb Surgical venture between Verily (formerly Google Life Sciences) and Johnson & Johnson, aims to bringing digital thinking into the surgical suite.Arundhati Parmar For the past two decades, Intuitive Surgical has set the terms of surgical robotics, being the only game in town. That hegemony is slowly being challenged with the expected approval any day now of TransEnterix’s SurgiBot.But Alphabet (formerly Google) has had its eye on this market as...
  • Is the Robot Takeover Hitting a Speedbump?

    Robots have been called "the next big thing" in technology  for decades. While that still may be true, the robot revolution could be slower than many expected, and Google's parent is rumored to be selling off one of its robotics divisions.Brian BuntzProponents of robotics still argue that robots will soon transform culture and medical care. It is likely that robots will take on ever-more important roles in fields as diverse as surgery and elder care while also doing a growing number...
  • Abbott Wins $1 Billion Stent Lawsuit

    Abbott Laboratories emerged victorious in a lawsuit that alleged the company had encouraged medical providers to submit false payments for stents to Medicare.Qmed StaffA federal jury in Dallas this week sided with Abbott Laboratories in a False Claims Act lawsuit that carried a potential $1 billion in damages for the company.A whistleblower named Kevin Colquitt, a former regional sales director for Guidant, had alleged that the company was promoting bile duct stents for treating digestive tract...
  • How a Medtech CEO Beat Felony Charges

    Vascular Solutions CEO Howard Root says he did everything he was supposed to when it came to compliance. But he nevertheless went through a five-year ordeal with federal prosecutors in which he faced prison time and countless employees and customers were interrogated over felony charges related to alleged off-label promotion of a laser ablation device for treating varicose veins.Chris NewmarkerHoward RootAre there any medical device industry executives truly immune from prosecution in the...
  • Theranos Beefs Up Board in Light of Lab Problems

    Reeling from months of negative press coverage and warnings from CMS and FDA, Theranos is beefing up its scientific and medical advisory board with eight medical and lab testing experts.Qmed StaffTheranos had raised eyebrows for the illustrious members of its board of directors, which included political luminaries such as former Secretary of State Harry Kissinger, former Senator Samuel Nunn, and former cabinet member George P. Shultz. But after the Wall Street Journal began a series of critical...
  • MD&M East Innovation Prize Official Rules

    NO PURCHASE OR PAYMENT OF ANY KIND IS NECESSARY TO ENTER OR WIN. A PURCHASE OR PAYMENT WILL NOT IMPROVE YOUR CHANCES OF WINNING. CONTEST IS VALID ONLY IN THE UNITED STATES (EXCLUDING PUERTO RICO) AND CANADA (EXCLUDING QUEBEC) – ENTRIES FROM PERSONS LIVING IN OTHER COUNTRIES WILL BE AUTOMATICALLY DISQUALIFIED. GENERAL CONDITIONS:The MD&M East Innovation Prize (the “Contest”) is sponsored by UBM LLC, 2901 28th St., Ste. 100, Santa Monica, CA 90405 (“UBM” or...
  • Who Is the Most Innovative Medtech Supplier at MD&M East?

    We are hosting a contest to acknowledge the most innovative new products, services, and technologies developed by MD&M East exhibitors.Jamie HartfordUBM is looking to identify the most innovative exhibitors at MD&M East and give them the recognition they deserve. The MD&M East Innovation Prize is a contest that will acknowledge the most innovative products, services, and technologies developed in recent years by exhibitors at the conference, held June 14–16...
  • How Microsoft Kinect Can Help MS Patients

    Microsoft Corp. and Novartis AG have teamed up to help physicians track multiple sclerosis patients’ symptoms using gaming technology.Nancy CrottiThe Assess MS system uses the Microsoft Kinect motion camera to obtain a more consistent reading of patient movements than a physician can with the naked eye. The technology could help physicians chronicle changes and find the best treatments for patients more quickly than they can today, according to a statement from Microsoft.Gamers know that the...
  • Northwestern Wins Myxo Trial But Questions Remain

    The hospital won a lawsuit filed by a patient who claimed she received an experimental implant during open heart surgery. Court testimony, however, revealed that the surgeon had been testing the implant he invented in a limited release. The surgeon in the case insists he was just following normal protocols. Brian Buntz A Cook County, IL–jury has found no merit in an eight-year-old lawsuit accusing Northwestern Memorial Hospital and a star cardiac surgeon of implanting an experimental medical...
  • Medtech Plasticizer Tied to ADHD in Children

    Scientists have linked the plastic softeners in medical tubing to neurological problems in children hospitalized with critical illnesses.Nancy CrottiA DEHP molecule representation shown on Wikipedia. The softeners, known as phthalates, had previously been linked to ADHD, allergies, asthma, hormonal imbalances, insulin resistance, and obesity. FDA recommended reducing their use in medical devices as early as 2002, according to a report in the Washington Post.“Phthalates have been banned from...
  • Researchers Are Creating 'Smart' Tampons

    Harvard researchers think the blood could be a useful source of health information for women.Nancy CrottiTemplate for centering an image and cutline below bylineTwo Harvard-trained researchers—Ridhi Tariyal (left) and Stephen Gire (right)—developed and patented a technology to capture menstrual flow and convert it into medical samples. (Image courtesy of Harvard University)Ridhi Tariyal was at a crossroads in her life. The Harvard researcher had just completed work on a long-term project. At 33...
  • 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...
  • 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-...
  • 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...
  • 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...