• St. Jude, Activist Investor Lock Horns Over Cybersecurity Report

    Stock trading was halted Friday as St. Jude issued a longer rebuttal to Muddy Waters Capital’s claims that St. Jude implantable cardio devices have major cybersecurity problems.Chris Newmarker St. Jude Medical on Friday accused activist investor firm Muddy Waters Capital and cybersecurity outfit MedSec of releasing a false and misleading report about the security of St. Jude devices. The report had sent St. Jude stock down nearly 5% in value on Thurday after its release. But...
  • Patient Death Numbers Could Be Fudged in the Thousands

    FDA adverse event reports apparently list the deaths as injuries or device malfunctions instead.Nancy CrottiMedtech companies have reported more than 4000 patient deaths to FDA as injuries or device malfunctions, according to a joint report by CNBC and NBC New York.A review of 30,000 adverse event reports going back to 1996 for one type of device, a vagus nerve stimulator, revealed 38 patient deaths reported as injuries or malfunctions, the report said. Five of those patients developed...
  • Medical Device Recalls Surged in Q2

    More than 40 million Class II units were recalled in the second quarter of 2016, up from less than 10 million in Q1.Qmed StaffAfter falling in the first quarter of 2016, medical device recalls surged 38% in the second quarter, to more than 263, tying Q3 2015 for the most recalls since Q3 2014, according to a report from Stericycle ExpertSOLUTIONS.Did you know: Medical device recalls hit an all-time high in 2014, and nearly a third of manufacturers experience multiple recalls for similar reasons...
  • Alere Sues to Complete Abbott Merger

    The lawsuit in Delaware Chancery Court comes at the same time Alere has more bad news: a Class I designation from FDA for a recall involving a quarter of a million handheld blood clot monitoring devices. Chris NewmarkerAlere said Friday that it is suing Abbott in Delaware Chancery Court in order to compel Abbott to complete its planned $6 billion merger. The diagnostic company's complaint seeks to get Abbott to promptly obtain all the required anti-trust approvals. For their part...
  • No. 70: Smith & Nephew

        No. 70 Smith & NephewInnovation Premium: 43.2%Smith & Nephew in recent years has made major investments in R&D, spending $222 million in 2015 alone. Innovations at the British medtech giant include not only products but new business models, such as the Syncera system for bundling a total joint replacement episode. Syncera includes not only the implant systems but also digital services, performance reviews, and metrics. Continue >>[Image...
  • No. 80: CR Bard

        No. 80 CR BardInnovation Premium: 42%After years of development and clinical research, sales of CR Bard's Lutonix drug coated balloon exceeded the company's expectations during its first full year of U.S. sales in 2015, according to the company's most recent annual report. With all sizes 5F, the Lutonix is touted as the lowest profile drug coated balloon on the U.S. market. CR Bard also boasts that 38 of the 40 products it launched in 2015 were the results of...
  • No. 83: Edwards Lifesciences

        No. 83 Edwards Lifesciences Innovation Premium: 41.3%Edwards Lifesciences continues to make great strides in the lucrative transcatheter aortic valve market. Just this month, Edwards's Sapien 3 valve became the first TAVR valve to receive an expanded FDA indication that included patients with intermediate risk of dying or suffering serious complications during open-heart surgery, versus the previous indication for only high risk patients. 10 Medtech...
  • How Ultrasound Gene Therapy Could Be a New Tool Against Cancer

    Researchers devise a method that combines ultrasound energy with microbubbles to open up cells to receive therapeutic agents. The invention could lead to new cancer therapies.Kristopher SturgisThe new technique, known as sonoporation, was created by researchers from the University of Pittsburgh and doctors from UPMC as part of a new study that aims to explore gene therapy as a new approach in the fight against cardiovascular disease and cancer. Brandon Helfield, PhD, a postdoctoral fellow at...
  • No. 67: Intuitive Surgical

        No. 67 Intuitive SurgicalInnovation Premium: 43.9%Surgical robots and sensors remain a hot medtech area, as evidenced in the premium investors appear to place in one of the leading companies in the area, Intuitive Surgical. The company’s da Vinci robots enable surgeons to perform complex procedures on a routine basis, all through tiny openings. The da Vinci System includes such innovations as an ergonomically designed console for the surgeon to sit while operating, a patient-...
  • No. 62: Essilor International

        No. 62 Essilor InternationalInnovation Premium: 45.2%The French maker of ophthalmic devices is the largest maker of lenses in the world. It spends 200 million euros (equivalent to $226 million) on innovation annually, and Essilor is also a robust acquirer of other companies.Recent innovations include Varilux Comfort, which boast sharp, natural vision at any distance, even in low lighting conditions. Essilor was able to achieve this through its proprietary WAVE technology that...
  • No. 22: Coloplast

        No. 22 ColoplastInnovation Premium: 57.5%The Danish medical device company boasts that an increasing number of people around the world who have a stoma, an artificial opening surgically created to relieve waste from the body, are using Coloplast’s stoma bags and accessories. "Our latest ostomy care product, the SenSura Mio Convex is now available in sixteen countries, and feedback from users and healthcare professionals remains highly satisfactory,” Coloplast CEO Lars...
  • The Most Innovative Medical Device Companies

        Finds out the six medical device companies making it onto Forbes’ list of the world’s 100 most innovative companies. And let us know which medical device companies you think are the most innovative. Chris NewmarkerHalf a dozen medical device companies made it onto Forbes’ latest list of the world’s 100 most innovative companies.Forbes bases the list on comparing how investors value a company and the actual cash flows coming into the company. The difference represents an “...
  • St. Jude Medical Could Have a Major Cybersecurity Problem

    Activist investment firm Muddy Waters Capital says cybersecurity vulnerabilities in implantable St. Jude Medical cardio devices are "orders of magnitude more worrying."Chris NewmarkerSt. Jude Medical's stock was down nearly 5% Thursday after an activist investor firm announced it was shorting St. Jude after discovering serious cybersecurity flaws in the company's cardio devices. Muddy Waters Capital says it learned of the cybersecurity problems after being contacted by research outfit...
  • Naming the Latest 3-D Printing Technology

    Qmed readers suggest such names as "Multi" 3-D Printing and Exponential 3D Printing. Chris Newmarker Researchers led by Michael McAlpine at the University of Minnesota have custom-built 3-D printers that are able to create at micron-level details using multiple materials, including living cells. (Photo by Chris Newmarker/Qmed)Qmed recently surveyed its readers for a better name for "multi-material, multiscale” 3-D printing—which has only arisen in recent years from custom-built printers created...
  • New Device Simulates Vision for Cataract Patients

    The device enables people with cataracts to preview how a new artificial lens will change their vision, before the lens is surgically implanted. Kristopher SturgisCarlos Dorronsoro and Susana Marcos at the Institute of Optics (Madrid, Spain) have tested the monocular SimVis device. They're now working on a binocular version to simulate different types of lenses in each eye. (Image courtesy of Carlos Dorronsoro/Institute of Optics)Traditionally when patients need cataract surgery, an...
  • FDA Spoke and Power Morcellator Use Dropped

    Or was it the fear of lawsuits that curtailed use of the laparoscopic surgical devices? Nancy CrottiJohnson & Johnson's Ethicon subsidiary pulled its Gynecare Morcellex Tissue Morcellator from the market in 2014 amid cancer spreading concerns. (Image courtesy of Ethicon)Use of power morcellators to perform hysterectomies dropped following a 2014 FDA warning, according to a study by Columbia University researchers.The study, published this month in the Journal of the...
  • How IBM Is Advancing Lab-on-a-Chip

        IBM researcher boast a lab-on-a-chip they've developed that is able to separate biological particles at the nanoscale, providing hope for detecting diseases such as cancer before symptoms appear. Tests of the chip, reported in the journal Nature Nanotechnology, showed it separating biological particles down to the scale of 20 nm, enough for detecting particles including DNA and viruses—and most importantly, exomes that are crucial for detecting disease at its earliest...
  • Recreating the Human Lung in a Device

        Tissue-engineered into a small plastic microfluidic device, the artificial lung presents an opportunity to test human lung response to drugs, toxins, and other conditions, according to the Los Alamos National Laboratory scientists who created it.Read the full Qmed story.Continue >>[Image courtesy of Los Alamos National Laboratory]
  • Advancing Electric Field Cancer Therapy

        The credit card–sized microfluidic devices—designed at MIT's research center in Singapore—are able to help scientists figure out how to safely use electric fields to boost cancer treatment.Read the full Qmed story.  Continue >>[Image courtesy of MIT]
  • Help for Preemie Babies From a Placenta-on-a-Chip

        A placenta-on-a-chip, developed at the University of Pennsylvania, could help when it comes to figuring out the causes of premature birth.Read the full Qmed story.Continue >>[Image courtesy of University of Pennsylvania]