• Congressman Wants Criminal Investigation of Morcellator Deaths

    Congressman Michael Fitzpatrick (R-PA) is seeking a criminal inquiry into deaths associated with the use of power morcellators, a controversial device that can unwittingly spread cancer in women who had uterine fibroids removed or hysterectomies performed.Brian BuntzRepresentative Mike Fitpatrick (R-PA, 8th District) is seeking answers from FDA, prominent hospitals, and device makers regarding morcellator deaths. In a letter to FDA’s Office of Criminal Investigations, Michael Fitzpatrick,...
  • Why Samsung Is Getting into the Wearables Chip Market

    The electronics giant has announced its plans to compete in the wearables space on two fronts: by continuing to compete head-to-head against other wearables makers while also providing chips to them. We reach out to an impartial industry veteran to get his take on the news.Brian BuntzJust before CES kicked off in Las Vegas, the company announced its Bio-Processor chip, which can monitor ECG levels, body fat, skin temperature, galvanic skin response, and heart rate. The Bio-Processor packs...
  • NBC Accuses CR Bard of Knowingly Selling Unsafe Device

    CR Bard’s G2 blood clot filter was meant to replace the troubled Recovery filter. NBC News now claims the device company continued to sell the G2 even after its officials were aware it could also fail.Both CR Bard's Recovery and G2 filters (the latter is pictured here) were placed inside the placed inside the inferior vena cava to catch blood clots. Qmed StaffCR Bard officials knew early on that their successor to the troubled Recovery blood clot filter was faulty, too, but they...
  • How a Glowing Bandage Could Tackle the Superbug Epidemic

    A new ‘smart’ bandage prototype could be used to alert healthcare professionals to the early signs of bacterial infections commonly found in wounds. The technology could improve wound treatments while also preventing the unnecessary use of antibiotics, and, by extension, the worsening superbug epidemic. Kristopher SturgisImage on left shows bandage before it contact bacterial toxins. The image on the right shows how it looks when activated by bacterial toxins.Researchers from Bath University in...
  • FDA Orders Vaginal Mesh Makers to File PMAs

    The U.S. FDA is tightening regulatory requirements for transvaginal meshes, which have turned into lawsuit magnets amid safety problems.Boston Scientific's mesh products include the Obtryx II. (Image courtesy of Boston Sci)Chris NewmarkerTransvaginal mesh devices used to treat pelvic organ prolapse will now be regulated in the U.S. as high-risk devices, with manufacturers required to submit a PMA submission, which requires data from a pivotal study.FDA on Monday issued two orders related...
  • Teknor Apex to Show Off New Materials at MD&M West

    The materials specialist Teknor Apex is seeing shifts in demands from medical device companies. Its product offerings at the MD&M West tradeshow will reflect these changes.Qmed StaffThe Medalist tubing sample kit from Teknor Apex is an examples of a product that will be on display at their booth (Booth #2438) at MD&M West 2016.Custom compounder Teknor Apex (Pawtucket, RI) declares that it has assembled the broadest range of compounds in the medtech industry, which it will feature at MD...
  • FDA Debuts Plan to Improve Medical Device Warnings

    Facing criticism from politicians and consumer advocates regarding its handling of medical device warnings, CDRH has announced draft guidance detailing how it will report possible medical device problems in the future.Brian BuntzLate in 2015, FDA commissioner nominee Robert Califf, MD was asked to address post-market surveillance of medical devices. Califf stated that he was not content with the current MAUDE database for tracking medical device events and stated that he supported revamping the...
  • Next-Gen Google Glass Eyes Healthcare and Manufacturing

    Having concluded that its Google Glass headset will not be a popular consumer item in the foreseeable future, Google is hoping healthcare and manufacturing institutions will boost the productivity of professionals ranging from doctors to assembly workers.Brian BuntzImages have surfaced of the next version of Google’s headset, which is referred to as model GG1 in FCC documents. While the new device looks similar to the first version of Google’s head-mounted display, the potential audience for...
  • Does Samsung Have a 'Pickax' in Wearables Gold Rush?

    While the Korean electronics giant continues to make its own wearables, it also plans to sell processors to makers of next-gen fitness tracking devices.Samsung is both making its own wearables while hoping to sell chips to competitors. Brian BuntzDespite the problems and the reservation from many consumers, the wearables field is booming, having expanded more than ten fold from 2010 to present—transforming from an industry worth $6.3 million to one worth more than $7 billion in five years...
  • Medtech Engineer Faces Jail Time for Theft of Trade Secrets

    A former Boston Sci engineer was handed a one-year sentence for stealing plans for a medical device.Qmed StaffAaron Q. Khieu, a former Boston Scientific engineer, admitted that he stole the design for a Mustang Plus balloon catheter. In afederal court in Minneapolis, Judge Patrick J. Schiltz handed Khieu a one-year prison sentence, which he said would serve as a deterrent to others tempting to steal secret product plans. According to the Star Tribune, he will likely spend 10 months in jail....
  • Cololplast to Pay Millions to Settle Kickback Allegations

    The FBI and DOJ accused Coloplast of paying kickbacks to five companies to help promote its products.Brian BuntzColoplast has had a rough year in 2015. In September, it announced plans to pay nearly nearly half a billion dollars to settle vaginal mesh lawsuits. That same month, it was one of the worst-performing medical device companies of the year. Although its stock has recovered since then, legal woes continue to haunt the firm at the close of the year.The company has agreed to pay $3,160,...
  • Samsung Wants to Make Wearables More Useful

    FitBit has coasted to a $7.5 billion valuation by selling products that primarily track steps. Samsung has announced that it has developed a processor for wearables that can do much more: gauging body fat, skeletal muscle mass, heart rate, skin temperature, and stress levels.Brian BuntzLittle has changed with fitness trackers since the first FitBit was announced in 2008. Current-generation devices may offer improved designs and somewhat improved functionality, but they still are primarily...
  • Theranos Data Tampering Allegations Could Prove Devastating

    The Wall Street Journal interviewed former employees at blood-testing firm Theranos who maintain the company had deleted unflattering quality control data. If true, the news could be a healthcare counterpart to the Volkswagen emissions scandal. Kristopher SturgisA promotional image from Theranos proclaims its vision of reshaping the future of lab testing. Recent press reports question if the technology sounds too good to be true. The most-recent exposé published by the Wall Street Journal...
  • Why We Are Driving towards Data-Driven Healthcare

    Google Maps users now have more information at their disposal about street than most doctors do for their patients. But the healthcare industry is starting to adopt consumer-inspired data technologies, which could change everything from how medical device software updates are performed.Brian BuntzElemental Machines CEO Sridhar Iyengar sees big potential in sensors and machine learning in the life sciences field. He will be chairing a session related to the subject at MD&M West in Anaheim in...
  • Senate Medical Device Bill Raises Concerns

    The degree to which lobbyists and FDA collaborated when drafting the text of the 21st Century Cures bill is peculiar, according to some legal scholars and consumer advocacy groups.  Brian BuntzAs early as next month, the Senate will consider passing “The 21st Century Cures Act” after the House overwhelming voted in favor of the bill, which passed with 344 votes in favor and 77 against on July 10.While supporters of the bill state that it will do much to improve patient access to new...
  • The Top 10 Medtech Crimes and Controversies of 2015

    2015 was a year marked by several eyebrow-raising reports of medical-device-related cancer outbreaks and infections, fraud, and the murder of a handful of medical device professionals. We look back at the biggest controversies and crime stories of the year.Qmed Staff1. Why a Company Acquired by J&J Is Accused of Major FraudBefore Johnson & Johnson acquired Acclarent for $785 million in 2010, its top executives were engaged in a host of fraudulent activities in anticipation of an...
  • How Nanotube 'Forests' Could Create Better Diagnostics

    MIT engineers think the nanotube coatings could be used to trap hard-to-detect molecules.Qmed StaffThe patterned and cylindrical structure is comprised of carbon nanotubes. (Image courtesy of MIT)A coating made of “forests” of carbon and nanotubes can be engineered to trap certain particles, providing the potential to finely tune microfluidic devices to detect extremely small and rare viruses and proteins, according to new research out of MIT.“There are smaller bioparticles that contain very...
  • Toshiba Could Be Pulling Out of Medtech

    The troubled Japanese multinational plans to sell at least a majority stake in its profitable healthcare business.Qmed StaffToshiba's roughly $3.5-billion-a-year makes diagnostic impaging equipment, such as the MRI machine shown above. (Image courtesy of Toshiba Medical Systems)Toshiba could be saying sayonara to part if not all of its medical device business amid a massive restructuring and layoffs meant to revitalize the Japanese multinational, which is still reeling from a major accounting...
  • Did Olympus Fail to Report Deadly Scope Problems?

    An Olympus employee in the Netherlands found contamination in a TJF-Q180V duodenoscope as early as 2012, but the Japanese multinational for years did not raise alarms in the U.S., according to an LA Times investigation.Olympus' TJF-Q180V duodenoscope, as shown on the company's websiteQmed StaffOlympus failed for years to alert U.S. hospitals that its TJF-Q180V duodenoscope had been linked to superbug outbreaks, even as the deaths mounted and more people were put at risk, according to...
  • These Stories of Medtech Derring-do Will Inspire

    Fretting over barriers stifling your innovation? Read these stories.Chris NewmarkerQmed readers this year were once again drawn to stories of necessity driving people to invention.For example, there was the story of Harry Paul (shown above), who has a congenital form of scoliosis, spending three years in high school working on a spinal implant. Paul, now a student at Tufts University, partnered with the K2M Group (Leesburg, VA) to refine its design and file a patent for it.Don’t let any...