• FDA Approves Allergan Glaucoma Device

    The gel stent reduces intraocular pressure in patients in whom previous treatments have failed.Nancy CrottiFDA has approved the Xen glaucoma treatment system, which provides a new treatment option for the millions of Americans with refractory glaucoma.Allergan acquired the Xen system when it bought Aliso Viejo, CA–based AqueSys last year. The system includes the permanent Xen45 Gel Stent, which becomes flexible after implantation,  and the Xen Injector. It is designed to reduce intraocular...
  • EpiPen Maker to Skip Senate Committee Hearing

    Mylan declined in a letter to the U.S. Senate Judiciary Committee, citing non-attendance by others.Nancy CrottiMylan N.V. will not testify at a U.S. Senate hearing regarding its proposed $465 million payment to settle claims that it overcharged the government for its EpiPen for several years.In a November 18 letter released this week by Senate Judiciary Chairman Charles Grassley (R-Iowa), an attorney representing Mylan wrote that it appeared the November 30 hearing would focus on the committee’...
  • The Surprising Reason for Medtronic's Disappointing Diabetes Sales

    Medtronic secured early FDA approval for its MiniMed 670G, the closest step toward an artificial pancreas for patients with diabetes, during its last fiscal quarter. So why were diabetes sales below expectations?Marie ThibaultIn its quarterly earnings report Tuesday morning, Medtronic reported sales that missed analyst expectations, notably in the Diabetes as well as Cardiac and Vascular Group businesses. At first glance, the shortfall in the Diabetes business may seem odd given the regulatory...
  • How GE Healthcare Is Turning to Deep-Learning Algorithms

    The algorithms will be deployed via GE’s Health Cloud and smart imaging machines to improve diagnoses and treatment recommendations.Maureen KingsleyGE Healthcare has forged a partnership with University of California San Francisco (UCSF) to create a library of deep-learning algorithms intended to help physicians diagnose and treat patients more accurately and effectively.“Deep learning” refers to the significant clinical and operational connections and insights machines can make from huge...
  • Contract Manufacturing Strategies Shift to Meet OEM Needs

    Contract manufacturers are expanding their offerings to suit the evolving needs of medical device OEMs.Frank VinluanPhillips-Medisize has added electronics to its contract manufacturing capabilities to meed demand for devices have complex capabilities, such as communicating with mobile devices.For some drug-delivery devices, the work of administering medication is just one aspect of the product. The convergence of pharmaceuticals and medical technology is producing devices that can track a...
  • Google-Novartis 'Smart' Contact Lenses Delayed

    Testing of the autofocusing lenses is now expected in 2017.Nancy CrottiHuman testing of the “smart” contact lens that Google’s health sciences sister company Verily is developing with Novartis will not be happening this year as predicted, according to a report by Reuters.Development of the lenses, which would focus automatically to correct for farsightedness, is "progressing steadily," a spokesperson for the Swiss multinational told the news agency."It is too early to say when exactly human...
  • Medicare Plans to Cover Leadless Pacers—Sometimes

    CMS recently proposed reimbursement coverage for leadless pacemakers through its Coverage with Evidence Development process. That means only implants that are part of FDA-approved studies will be eligible for coverage.Marie ThibaultThe Micra Transcatheter Pacing System was the first—and currently only—leadless pacemaker to gain FDA approval.In a recent proposed decision memo, CMS detailed its plan to offer reimbursement coverage for FDA-approved studies of leadless pacemakers. The proposal,...
  • Medtronic’s Solitaire Device Earns Expanded FDA Indication to Reduce Stroke-Related Disability

    Next goal, says Medtronic, is to ensure hospitals have “protocols in place” to provide this treatment.Maureen KingsleyMedtronic announced earlier this week that its Solitaire stent-retriever device has been cleared by FDA for an expanded indication in the treatment of acute ischemic stroke. Medtronic is now free to market the device as an initial therapy for this condition to reduce symptoms of paralysis, speech difficulties, and other disabilities in patients with “a persistent, proximal...
  • Examining Intellectual Property Concerns In Medical Device Development

     From patent applications to FDA approvals, the process of protecting intellectual property has become more crucial than ever for designers and manufacturers.  Kristopher SturgisWhen it comes to designing and developing new medical device technologies, identifying and protecting intellectual property is often an overlooked step that can have serious consequences. Unlike traditional forms of technology, medical devices often require clinical studies, peer reviews, FDA approvals,...
  • BD is Doubling Down on Diabetes Care

    At the company's recent analyst day, management previewed a packed diabetes care pipeline. Qmed StaffAt an analyst day on November 17, Becton Dickinson and Co. (BD) management shared its ambition to grow the Franklin Lakes, NJ, company’s topline revenue by around 5% from 2017 to 2019. Part of their plan includes launching a steady stream of innovative diabetes products over the next few years.Learn what it takes to innovate in the connected health space at the BIOMEDevice San Jose...
  • Global Market Trends in Surgical Navigation

    Innovation in pricing and partnerships is driving growth in the image-guided surgery segment.Ash Milton and Kamran Zamanian, Ph.D.Image-guided surgery has expanded over several decades from a technology geared toward neurosurgery to one with a wide array of procedural applications. Although dominated by several established companies, the market continues to see growth in the United States and Europe as spinal; ear, nose, and throat (ENT); and orthopedic (hip and knee) applications are promoted...
  • Do Device Reps Have a Place in the OR?

    A new report form Kaiser Health News questions the ethics and effectiveness of allowing medical device salespeople in the operating room.Qmed StaffMost patients expect doctors and nurses to be present in the operating room (OR) when they undergo a medical procedure, but there’s one person they might not expect to see: a medical device sales representative.Don't miss the BIOMEDevice San Jose conference, December 7–8, 2016.According to a new report from Kaiser Health News, device reps attend...
  • Olympus Launches New Laparoscopic Morcellator

    The Japanese multinational claims its PK Morcellator, which FDA has cleared, restores a minimally invasive surgery option that had previously declined amid cancer-spreading worries. Chris NewmarkerOlympus on Wednesday announced FDA 510(k) clearance for its next-generation laparoscopic PK Morcellator, which it says restores a minimally invasive surgery option for low-risk hysterectomy, myomectomy patients.Use of power morcellators to perform hysterectomies dropped after FDA issued a 2014...
  • BIOMEDevice San Jose Innovation Prize: Meet the Finalists

    Discover some of the most innovative exhibitors at the upcoming BIOMEDevice San Jose show. Chris NewmarkerFrom more reliable nitinol to enabling MRI-compatible catheters to simplified catheter packaging, there are a wide variety of innovations among the five BIOMEDevice San Jose innovation prize finalists chosen by UBM editors and readers. Check out the five finalists yourself on Wednesday, December 7, at 1 p.m., when MD+DI managing editor Marie Thibault leads an Innovation Tour out...
  • More Evidence Links Heart Surgery Device to Infections

    Heater-coolers made by LivaNova are seen as the source.Nancy CrottiUpdated November 16, 2016LivaNova’s 3T heater-cooler system A study by Swiss researchers has confirmed suspicions of a link between heater-cooler devices (HCDs) and stubborn mycobacterial infections.The study, published in the journal Infection Control & Hospital Epidemiology, linked the devices used during cardiac surgery in most hospitals worldwide to the invasive, slow-growing Mycobacterium chimaera. FDA...
  • Medtech Has a Major Interoperability Challenge

    The dream is a seamless ecosystem of connected medical devices—all leading to more effective and affordable management of people’s health. Here are the challenges standing in the way.Chris NewmarkerInteroperability is a major challenge when it comes to creating medical devices that easily connect with everything from other devices and sensors to health providers’ electronic medical record systems.Think of the biblical story of the Tower of Babel and how the people of the Earth were thrown into...
  • St. Jude, Medtronic Win MRI-Compatible FDA Approvals

    The trend toward MRI-compatible implants continues as Medtronic and St. Jude Medical announce FDA approvals for MRI-compatible devices.Marie ThibaultMedtronic racked up another FDA approval for an MRI-compatible cardiac rhythm device while St. Jude Medical also announced agency approval for MR-conditional labeling of a spinal cord stimulation system.The regulatory approvals, both announced November 14, are the latest developments in an industry-wide trend toward MRI-safe implants. In...
  • Brain Implant Lets ALS Patient Communicate

    A paralyzed Dutch physician implanted with Medtronic devices was able to operate a speech computer by imagining using her fingers. Nancy CrottiAn implanted brain-computer interface that utilizes Medtronic components has allowed a paralyzed woman to communicate using only her thoughts.Researchers in the Netherlands implanted deep-brain stimulation components made by Medtronic in a 58-year-old internist and late-stage ALS patient Hanneke De Bruijne, MD, in October 2015. Until receiving...
  • 3-D Printed Brain Models Could Improve Surgery

    Researchers aim to improve patient outcomes during neurological surgery through the use of 3-D printing brain models. Kristopher Sturgis3-D printing techniques continue to carve out a space in various realms of the medtech arena, and they soon could have a significant impact on neurosurgery thanks to the joint efforts of St. Louis University and the Walter E. Dandy Neurological Society. Their recent study explores the process of 3-D printing precise replicas of patients’ brains to provide...
  • Medtronic Makes a Big Bundled Ortho Payments Play

    The medtech giant has launched a new orthopedics business centering on Medtronic Orthopedic Solutions, which includes a host of offerings meant to help health providers drive outcomes.Chris NewmarkerMedtronic on Thursday announced the launch of its Orthopedic Solutions Business, a Total Knee Arthroplasty System, and a Medtronic Orthopedic Solutions package meant to help health providers succeed under the new bundled payment models being rolled out by both public and private health insurers...