• How Krypton Could Make for Better MRI Lung Images

    UK researchers take MRI imaging to the next level with a new scanning method that provides high resolution images of lung disease and pulmonary tissue. Images produced by the new technique (Courtesy of University of Nottingham)Kristopher Sturgis The new imaging technique  uses specially treated krypton gas that can be inhaled and used as a contrast agent to reveal new areas of the lung on an MRI scan. The new process was developed at the Sir Peter Mansfield Imaging Center at the...
  • Engineers Create Living Tissue From 'Human-On-A-Chip' Technology

    The new technology could serve as a platform for growing human tissue outside the body that could eventually be used to repair or replace failing human organs.Kristopher SturgisA platform known as AngioChip could take tissue engineering to new heights as a group of researchers from the University of Toronto have created a new unique method for growing human tissue in a lab in conditions that can mimic the human body. Their design was modeled after electronic microchip technologies that carry...
  • Pelvic Mesh Maker: Women had Unnecessary Surgeries for Profit

    The medical device company AMS had agreed to pay $1.6 billion to settle lawsuits over its vaginal mesh products. But now it is fighting back, claiming in court that there were plaintiffs who had unneeded surgical procedures to drive up settlements against mesh companies. AMS is also subpoenaing some of the law firms involved in the litigation. Brian BuntzAmerican Medical Systems (AMS), a urology company that made vaginal mesh, is striking back after announcing in 2014 that it would pay $1.6...
  • FDA Clears Parker Hannifin Exoskeleton for Personal and Clinical Use

    Parker Hannifin says that its FDA clearance will give 270,000 people with severe spinal cord injuries the opportunity to walk again. Convincing payors to cover the device, however, could be a challenge. Brian BuntzParker Hannifin Corp. has convinced FDA to clear its 26-lb. exoskeleton, which could be used to treat up to 1.7 million people in the United States—including more than a quarter-million people with severe spinal cord injuries. There are roughly 12,500 new cases of severe spinal injury...
  • Apple Invents Emergency Alert System

    Apple has filed a patent for a medical monitor that can sound an alert based on irregularities in a user’s temperature, heart rate, oxygen level, or blood pressure.Brian BuntzIn its patent filing with the U.S. Patent & Trademark Office, Apple states that the device can detect “care events” and sound alerts in the case of medical emergencies such as a heart attack or a fall. In addition, the device could alert family or police of events such as car crashes, bike accidents, a mugging, or the...
  • Q&A: Meet the Developer of a Wristband That Detects Seizures

    A research project related to detecting emotions in people with autism eventually found use for helping epileptics.Qmed StaffThe wearables of the future can do a lot more than track steps. A number of startups and university researchers are working on developing clinically relevant wearables that can do everything from monitor hydration to blood pressure to detect medical problems such as seizures. To learn more about the latter, we reached out to an MIT researcher who has helped develop a...
  • Senate Committee Votes to Accelerate Device Approvals

    A Senate committee has approved legislation intended to speed regulatory timelines for medical devices in the United States.Qmed StaffThe legislation, known as MEDTECH Act (S. 1101), is intended also to foster medical research at the National Institutes of Health, a goal of Democrats.The legislation will likely be made part of a larger effort to boost FDA and NIH funding and President Barack Obama’s Precision Medicine Initiative, which is intended to help boost research on new cancer treatments...
  • Wrist-Worn Wearable Can Detect and Maybe Prevent Seizures

    A wristband can monitor stress signals in epileptics to detect and warn of impending seizures.Kristopher Sturgis A new device, known as Embrace, is the product of a new company called Empatica— an organization that specializes in the development of wearable devices using medical quality sensing technologies. The project was aimed at providing a novel tool for patients who suffer from epilepsy, a neurological disease that is characterized by unprovoked seizures that can lead to a fatal...
  • Google's Verily Developing Medical Device Hub

    Google’s life sciences company Verily has submitted photos and more information in its quest to land the federal government’s permission to use a “connectivity bridge” to collect patients’ medical data, according to media reports.Nancy CrottiGoogle’s life sciences company Verily has submitted photos and more information in its quest to land the federal government’s permission to use a “connectivity bridge” to collect patients’ medical data, potentially giving Qualcomm a run for the money in...
  • How Lawsuits and M&A Activity Affects Device Firms' Credit Ratings

    There has been a recent uptick in news stories about medical device company mergers, not to mention product liability lawsuits filed against medical device companies. To learn about how these two trends could impact medical device credit ratings, we reached out to an analyst at S&P.Brian BuntzLast year went down as the biggest year for M&A activity on record, and this year is looking similar thus far.  Another trend—albeit an unrelated one—is a growing amount of medical device...
  • 6 Factors That Wreak Financial Havoc for Medtech Companies

         Good old-fashioned fraud, reimbursement cuts—those are but some of the major factors that have doomed medical device companies and sent them on the road to default, according to a new report out of Standard & Poor's.Brian Buntz and Chris NewmarkerIt is rare for medical device companies to default, although the number of defaults in the sector has risen in recent years. Over the past 30 years, the most common causes of default were fraud and accounting problems,...
  • 1. Fraud and Accounting Problems

         1. Fraud and Accounting ProblemsTaken together, fraud and accounting problems were responsible for one third of medical device firm defaults, causing a total of five defaults. In S&P’s report, the consultancy notes that it did not expect to find that fraud would be a common cause of default for medical device companies. In the end, the prevalence of fraud in the sector is higher than in other industries because of the high prevalence of third-party payments in...
  • 2. Reimbursement Cuts

         2. Reimbursement CutsBehind fraud and accounting problems, the most common cause of medical device defaults was a reduction in reimbursement, which has caused three major medical device company bankruptcies in the past three decades.S&P closely monitors decline in price or reimbursement of medical devices, given that many of the products are substantially cheaper in other geographies outside the United States.Reimbursement cuts ultimately led to the defaults of the...
  • 3. Product Liability

         3. Product LiabilityProduct liability is an issue S&P is monitoring closely for high-tech medical device makers, says David Kaplan, director, healthcare group at Standard & Poor's Ratings Services. “That is a prominent issue for a number of medical device companies right now, with the number of companies defending themselves against billions in claims from pelvic mesh and metal-on-metal hip implant related lawsuits.”While not as common as the aforementioned...
  • 4. Decline in Demand

         4. Decline in Demand“Decline in product demand is more of an issue for companies with product concentration,” observes Kaplan, who cites companies like  Zest Anchors (see S&P summary from April 2015 above) and Kinetic Concepts as examples of how product concentration can hurt credit scores.It is rare for new medical products to rapidly gain market share. For that reason, many healthcare companies have time to adapt to market changes.Occasionally, however,...
  • 5. Excessive Debt Levels

         5. Excessive Debt LevelsIn two cases, a “winner’s curse” in a leveraged buyout and the resulting excessive debt level proved too much.“Debt levels are an important part of our analysis,” Kaplan says.Maxxim Medical Group, for example, used a series of acquisitions to become a leading U.S. producer of nonlatex medical gloves and custom procedure trays during the 1990s. It went private in 1999 through a leveraged transaction largely financed by debt, only to then be hit...
  • 6. Rapid Pace of Acquisitions

         6. Rapid Pace of AcquisitionsGraham-Field Health Products Inc. still makes thousands of items for healthcare and home health care settings. But the company had its own run-in with default in 1999 after a rapid series of acquisitions in the late 1990s. Then-CEO Irwin Selinger had the company do eight acquisitions in 1996 and 1997. By 1998, Selinger was resigning as the company struggled to smoothly digest the acquisitions amid a string of unprofitable quarters and...
  • Here's How You Build Biobots

    A new National Science Foundation video shows off the incredible strides made by Illinois researchers when it comes to creating robots powered by living cells.Qmed StaffScientists led by Rashid Bashir at the University of Illinois at Urbana-Champaign have created tiny living machines called biobots that utilize skeletal muscle cells. The biobots are controlled with electrical or optical signals.Work has progressed since Qmed last reported on the technology in 2014. For now, the biobots kind of...
  • Meet Dreamer: One of the Best Humanoid Robots Yet

    Researchers from the University of Texas at Austin have created a new wave of enhanced robotic technologies designed to efficiently perform tasks and interact safely with humans. Kristopher SturgisLuis Sentis, an assistant professor of engineering at UT Austin, shakes hands with Dreamer. (Image courtesy of UT Austin)The latest prototype, called Dreamer, was designed from head to toe by researchers and students at the University of Texas at Austin. The project was designed to create a new...
  • How 3-D Printing Played a Role in the Super Bowl

    In case you missed it, last month's Super Bowl 50 marked the first time an NFL player wore a 3-D printed medical device at the game. Qmed StaffThomas Davis tried out the 3D-printed brace during practice. (Image courtesy Carolina Panthers.)The Carolina Panthers may have fallen to the Denver Bronco's in last month's Super Bowl 50. But Panthers Thomas Davis was still connected to a "first": the first time a football player has worn a 3-D printed medical device during a football game.Qmed's sister...