• The Top 5 Medical Device Companies of 2015

              2015 may go down as a comeback year for the cardiovascular device sector. It wasn’t long ago that many professionals in the industry assumed the niche’s glory days were over. But this year, many of the most successful device companies have been expanding their cardiovascular businesses.  It’s not surprising then that four of the top-performing major medical device firms had their growth fueled—at least partly—by their...
  • Interventional Cardiology Drives Boston Sci Growth

    The Watchman left atrial appendage closure device and Lotus TAVR device are among the company’s innovative cardiovascular products. Chris NewmarkerBoston Scientific CEO Michael Mahoney in recent years has been making good on his promise to turn around years of sluggish performance. The company’s stock has roughly tripled in value since late 2011, and is up 42% so far this year. In fact, a report from Evaluate Medtech found that the company’s share price rose 34% in the first six months of the...
  • Cardiology Pumps Up Terumo's Profits in 2015

    The Japanese company’s stock is up by nearly a third in value so far this year. Terumo, as with many medical device companies that fared well in 2015, has a strong cardiovascular business, having acquired some of their assets in this area from 3M in 1999 and UK-based Vascutek Ltd in 2002. Since then, the company’s share price has grown steadily for the most part, and the company has acquires a handful of other cardiovascular firms, including MicroVention Inc., the heart valve division of Köhler...
  • Edwards Stock Hits All-Time High This Year

    Edwards Lifesciences' latest TAVR device, approved by FDA in June, includes a major design change to solve previous leakage issues. Chris Newmarker Edwards has certainly had meteoric growth since the beginning of 2014, with its stock rising from the mid-$60 range then to the $155 range in July of this year. After a 2-for-1 stock split this month, its roughly $80 per share stock is still trading 28% higher than comparable stock at the start of the year. Not bad considering the company’s...
  • Nipro Takes Off in 2015 Despite Asia's Economic Woes

    Dialysis and cardio products are some of the Japanese company’s major growth drivers.Chris NewmarkerDespite a deteriorating Chinese economy and a still-recovering Japanese economy, Nipro has managed to continue growth, boosting sales by 16% and profits by 3% year-over-year during the six months ended September 30. The company credits “continued efforts to expand sales and reduce costs.” Nipro reports solid performance for its injection-transfusion products, enteral-alimentation products,...
  • 3-D Mammography Sends Hologic Skyrocketing

    FDA-approved Genius 3D mammography systems played a major role in Hologic’s stellar growth this year.Chris Newmarker Mammography innovation has been driving stellar growth for Hologic, which saw its stock value rise 46% through much of 2015. The Bedford, MA–based medtech company says it has been seeing accelerated adoption of its FDA-approved Genius 3D mammography systems, with breast imaging and services up 26% during the fourth quarter alone. Hologic boasts that the 3-D imaging is able...
  • Why Google's Robots Could Drive New Surgical Possibilities

    Johnson & Johnson and Alphabet Inc.’s new life sciences division, Verily Inc., have launched a new company to develop smaller and less expensive surgical robots.Nancy CrottiWhile Google has made a name for itself recently for innovating in the field of self-driving cars, the company, through a new subsidiary, “aims to develop a comprehensive surgical solutions platform that will incorporate leading-edge robotic capabilities and best-in-class medical device technology for operating room...
  • Nearly 50 Docs Accused in Spanish Kickback Scandal

    More than 6000 patients in Spain are being closely monitored for adverse events in the wake of a kickback scandal that resulted in some patients being treated with orthopedic implants used 10 years after their expiration date.Qmed StaffSpain is being rocked by one of the biggest medical crises in decades according to the newspaper El País. Thousands of patients may have been implanted with devices that were marketed illegally—without CE Mark approval. In some cases, patients were treated with...
  • Could This Super Fast Nanomotor Make a Difference?

    UT Austin engineers are boasting a nanomotor with the speed of a jet airplane engine.Chris NewmarkerUT Austin researchers used AC and DC electric fields to assemble the nanomotor’s parts one by one. (Illustration courtesy of UT Austin)It is less than 1 μm in size—able to fit inside a single human cell. And it can rotate for 15 continuous hours at a whopping 18,000 rpm.University of Texas at Austin engineers are touting what they say is one of the smallest, fastest, and longest-running synthetic...
  • Is Off-label Promotion Out of Control?

    The situation raises the question of whether more regulatory clarity is needed regarding the use of medical devices for off-label treatments.Qmed StaffOff-label promotion of medical products has been a central issue in many U.S. product liability lawsuits. But when it comes to marketing a device for uses not expressly indicated, it has proven hard to draw the line between legal off-label use and illegal promotion that skirts FDA’s authority.Stryker is facing two new product liability lawsuits...
  • Power Morcellation Gets Government Attention

    The case of laparoscopic power morcellators is especially disturbing, because a widely used device turned out out to be especially dangerous.Qmed StaffLaparoscopic power morcellators, used for 24 years in the U.S. to slice up tissue during laparoscopic hysterectomies and myomectomies, can also potentially spread cancer in women, it turns out.How did that happen? Even members of the U.S. Congress are asking the question, with morcellators featured in a House Committee on Energy...
  • Infusion Pumps and Cybersecurity

    Are medical device companies too often ignoring or deprioritizing security problems?Qmed StaffThe theme of medical device cybersecurity has been making headlines for years but, in 2015, the topic received unprecedented attention.Security researcher Jeremy Richards described the Hospira Lifecare PCA 3 drug-pump as “the least secure IP enabled device” he’s examined.The U.S. Computer Emergency Readiness Team—a subsidiary of the Department of Homeland of Security—released its own warning about the...
  • 5 Medical Device Concerns That Made Us Worry in 2015

    The end of the year is a great time to reassess, not just for individuals but for whole industries. In that spirit, here are five medical device stories that scream for lessons learned as we enter the new year.Qmed Staff            Deadly superbug outbreaks related to duodenoscopes have caused a reassessment of the way endoscopes and devices in general are cleaned, and Hospira infusion pump hacking issues have raised the profile of...
  • Superbug Infections Spread by Devices

    While superbug infections are nothing new, there was a surge in interest and lawsuits related to them in 2015, thanks to deadly outbreaks associated with a particular type of endoscope called a duodenoscope.Qmed StaffIn early 2015, the Olympus TJF-Q180V duodenoscope was linked to a deadly superbug outbreak at UCLA’s Ronald Reagan Medical Center in which at least seven patients were infected and two died. The hospital reported that 179 patients may have been exposed to the drug-resistant...
  • The Revolt Against Bayer's Essure

    As with laparoscopic power morcellators, something appears not right when it comes to a device that has seen widespread use over the years.Qmed StaffBayer claims that only a small portion of the hundreds of thousands of women implanted with its Essure contraceptive device have had a bad experience with it. But the needle appears to be moving amid vocal criticisms from thousands of women reporting problems.FDA has received nearly 6000 reports of problems related to Essure, many listing multiple...
  • Indian Medtech Industry Seeing Healthy Growth

    The government of India has agreed to separate the regulation of medical devices from that of pharmaceuticals, following longtime pressure from the device industry.Nancy CrottiIndia health ministry has agreed to separate schedule M III of India’s Drug Rules, which regulates medical devices, from schedule M, which controls pharmaceuticals, according to a report in the Times of India.India’s Central Drugs Standards Control Organisation plans to post the revised schedule on its website, and will...
  • Meet the AI Algorithm That Learns Like Humans Do

    A new approach to AI programming yields a system that can recognize a handwritten character or symbol after seeing it just once, paving the way for more advanced and efficient AI systems. Kristopher SturgisBrenden Lake of New York University compares AI-drawn images vs. human-drawn images. (We are not telling you which is which.) To see if you can spot the difference, check out his website. While the field of artificial intelligence dates back to the mid 1950s, most of what passes for AI...
  • Venture Funding in Digital Health Holds Steady in 2015

    2014 was a record year for digital health funding but 2015 has kept track. Brian BuntzLast year, the digital health sector accounted for an impressive 7% of all venture funding while the software sector attracted 40% of VC cash. This year, digital health funding maintained a similar level while medical device funding dipped to 4.5%—behind not just digital health, but also biotech.In 2014, digital health funding hit $4.3 billion. In November, the sector hit that same benchmark, while medical...
  • Dow, DuPont Set for $130 Billion 'Merger of Equals'

    The chemical giants have announced a plan to merge and then break apart into three separate entities. Qmed StaffDow and DuPont have agreed to merge in what the two companies term a “highly synergistic transaction” that will ultimately result in billions of dollars of cost savings and will create roughly $30 billion of market value.The plan was unanimously approved by the boards of directors at the two companies, and is scheduled to close in the second half of 2016, subject to customary closing...
  • Medtronic Expands Use of Controversial Infuse Product

    Medtronic’s prized biologic was just granted approval for use with two additional indications. Having reached sales of close to $1 billion at its height, the combination product, originally approved as the Infuse Bone Graft/LT-Cage, has been mired with lawsuits and Senate probes—and has been hotly debated among the medical and legal community.Brian Buntz(updated on December 14)FDA has granted a PMA supplement approval to Medtronic for use of the Infuse synthetic bone graft with the spinal...