• Weekly Vitals: St. Jude Medical Gets FDA Surprise, More Backlash

    Bad press has plagued St. Jude Medical's ICD leads since the Riata recall in December and the company is now riding out the latest wave. During the past week, the company received a surprising order from FDA to conduct studies on the recalled Riata as well as the non-recalled Durata and other leads. Then, it was dealt another public blow upon the release of a study questioning the safety of its Durata lead, which St. Jude has fervently been promoting to deflect the bad press stemming from the...
  • Cardiologist Proves to be Thorn in St. Jude’s Side for ICD Leads

    Noted cardiologist Robert Hauser can’t seem to stop giving St. Jude Medical palpitations. The embattled medical device manufacturer has spent the majority of 2012 in damage-control mode as it publicly dealt with the fallout from the recall of its Riata implantable cardioverter-defibrillator (ICD)  leads, the subsequent skepticism cast on its Durata leads, and the recent blow from FDA ordering the company to conduct studies on the Riata, Durata, and other leads. Yet despite the steady...
  • Nanofiber Stent Coating Encourages Arterial Healing

    Transmission electron microscopic images show the structure of BioNanomatrix, a natural, peptide-based nanofiber material developed by Endomimetics to inhibit the proliferation of smooth muscle cells and prevent platelets from clotting.Cardiovascular disease is the leading cause of death in the United States today, resulting in the implantation of more than two million stents each year. Although stents are lifesavers, however, they are far from trouble free. While 15 to 45% of all bare-metal...
  • Big Corporations Set to Outshine Startups in 'Fourth Era of Innovation'

    Pioneering startups have often been credited with pushing the boundaries of medtech innovation for the past several decades. And while medical device powerhouses such as Medtronic and Boston Scientific have also been instrumental in developing progressive technologies, they often look to the little guys for both inspiration and acquisition potential. But a paradigm shift could be on the horizon as major corporations—not VC-backed startups—usher in an impending 'fourth era of innovation' that...
  • Retinal Implant Could Crack the Code to Restoring Sight in the Blind

    The three blind mice immortalized in nursery rhyme could have had entirely different fates today, thanks to a breakthrough in retinal implants that has restored sight in blind mice. Researchers at Weill Cornell Medical College have cracked the code for both a mouse and a monkey retina's neural code, which has enabled them to develop a working artificial retina for mice that they hope will pave the way for a similar device that will restore sight in humans.When caused by diseases of the retina,...
  • Novel Wrist-Worn Device May Mitigate mHealth Security Risks

    Wearable technologies are on track to be a $6-billion industry by 2016. But despite the potential mHealth, wearable sensing, and telemedicine applications hold, such wireless medical technologies also pose significant vulnerabilities to patients in terms of security and privacy. Aiming to prevent hacking and privacy breaches, a team of researchers from Dartmouth College (Hanover NH) and Myongji University (South Korea) have proposed the development of a wrist-worn platform dubbed the Amulet...
  • Northern Indiana Pursues Development of Medical Packaging Cluster

    Home to Warsaw, IN—also known as the "Orthopedic Capital of the World"—Northeast Indiana boasts $12 billion in total regional orthopedic device industry revenues in addition to nearly 100 life sciences, orthopedic, and medical device companies. Looking to leverage and support these local thriving orthopedics and life sciences sectors, Northeast Indiana's Whitley County Economic Development Corp. is now launching an initiative to cultivate a medical device and disposables packaging cluster....
  • Weekly Vitals: Ossur Shines at Olympics, 'Smart' Devices Give Patients Power, and More

    Among the most-talked-about stories at this year's London Olympics was that of South African Sprinter Oscar Pistorius. A double amputee, Pistorius simultaneously won over crowds and fellow athletes alike and generated debate as to whether his artificial limbs, made by Ossur, gave him any sort of unfair advantage. Plus, the Wall Street Journal examined smart prostheses and other medical devices. Read about these and more of the top stories from the past week in our roundup below.How Ossur Made...
  • Anemia-Detecting Cell Phone Device Could Impact Pregnant Moms, Newborns in Developing Countries

    Innovative and tech-savvy university researchers have been pioneering the development of low-cost medical devices that leverage cell phones, which are often much more accessible in developing countries than traditional medical devices or technologies. Continuing to push progress in this area, student researchers at Johns Hopkins University have created an inexpensive technology that converts a healthcare worker's cell phone into an anemia-detection device for pregnant women and newborns that is...
  • Bioactive Coating Improves Efficacy, Longevity of Implants for Deep Brain Stimulation

    Deep brain stimulation has emerged as an exciting and promising field for treating both neurological and psychological disorders ranging from Parkinson's disease to depression. But the long-term viability of implants designed for DBS remains uncertain as current electrodes tend to induce an immune response in the patient's body that reduces the treatment's efficacy over time. Looking to overcome this challenge, researchers at Tel Aviv University (TAU) have developed a bioactive coating for...
  • Weekly Vitals: Chick-fil-A and the Medical Device Industry, Medtech M&A, and More

    Former Vante CFO Adam Smith brought some unexpected controversy to the doorstep of his employer, a supplier to the medical device industry, this past week. Smith gained national attention when he posted a video on YouTube that went viral showing him berate an employee of the fast-food chain Chick-fil-A for working for the company, whose president, Dan Cathy, has openly opposed same-sex marriage. Smith was fired and issued an apology following the uproar. In other news, MPMN explores the driving...
  • Smoothing the Way for Diamond-Based Medical Device Coatings

    While efforts are afoot at the University of Alabama Birmingham (UAB) to develop nanodiamond coatings for use on hip and knee implants, Vista Engineering at Birmingham’s Innovation Depot technology incubator is close to completing studies to employ the coating on implants for treating temporomandibular joint disease (TMJD). Resulting in chronic pain and disability, TMJD is the second-most common musculoskeletal condition in the United States. It affects up to 37,000,000 people, approximately 50...
  • Researchers Design Microrobots That Can Swim

    At the micron scale, objects have difficulty swimming because the viscosity of water prevents objects from relying on momentum to maintain forward motion. Now, researchers at the Georgia Institute of Technology (Atlanta) have used complex computational models to design swimming microrobots that could overcome these challenges. Ultimately, the researchers' work could contribute to the development of robots capable of serving as drug-delivery vehicles.Designed by Alexander Alexeev, an assistant...
  • In Ortho Implants, Diamonds Are a Coating’s Best Friend

    Future artificial hips and knees will face two interlinked design and materials challenges: They will have to be able to prevent the release of particulate debris while surviving in the body for years on end. However, as evidenced by the 2010 recall of DePuy Orthopaedics’s ASR XL acetabular and ASR hip resurfacing systems, today’s hip and knee implants can generate debris, leading to inflammation and the need for revision surgeries. Among the efforts to develop orthopedic implant coatings...
  • Birmingham: Rising Star in the South

    When you think of the biotech and medical device manufacturing industries in the United States, California's Silicon Valley, Massachusetts's high-tech clusters, and Minnesota's LifeScience Alley immediately come to mind. It is unlikely, however, that you’ll give much thought to Birmingham, AL. At least I didn’t before visiting the area in May as part of a press tour organized by the Birmingham Business Alliance (BBA).Unbeknown to many, however, Alabama’s largest city is an important and up-and-...
  • What’s Behind the Flurry of Medical Device M&A Activity?

    Recently, Qmed Daily reported that venture-backed life science acquisitions have hit a seven-year high. Based on an analysis by Silicon Valley Bank (Santa Clara, CA) of private mergers or acquisitions involving U.S. venture capital–backed bio- and medtech companies, the article noted that there were 35 big exits since 2005 and that $12.5 billion had been invested in life science firms in the same period. Medical device technologies receiving the largest investments since 2005 included...
  • FDA Tracks Faulty Devices, But What about Faulty Cybersecurity?

    Forbes reports that FDA's current surveillance system tracks such faulty medical devices as pacemakers, insulin pumps, defibrillators, and respiratory technologies. What the system does not do, however, is track such devices as Web-connected sensors and connectivity technologies used in such applications as wireless patient-data storage.Based on "Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance," a report in the journal PLOS, the Forbes article notes...
  • Weekly Vitals: Cook to Cancel Expansions, Medtech Expands Offshore, and More

    All eyes last week were on Cook Medical’s announcement that the provision in the Affordable Health Care for America Act imposing a 2.3% excise tax on the first sale of medical devices has forced the company to cancel plans to build five plants in the Midwest. Since then, voices are being raised that the tax will hurt Indiana. In other news, more medtech firms are starting up offshore operations, while Zimmer announced mixed quarterly results.Cook Medical Says It Won't Build Five Midwest Plants...
  • Enhanced Dyes Improve Nanoparticle Fluorescence

    The use of fluorescent nanoparticles loaded with organic light-emitting dyes are expected to transform live-animal imaging technologies because they are optically stable and nontoxic. In addition, they can be easily modified with functional groups, making them suitable when targeting specific tissues. However, traditional dyes aggregate and lose their emission intensity when incorporated into nanoparticles at high concentrations. In response, researchers at the A*STAR Institute of Materials...
  • Simulator Could Help Improve Knee Implant Design

    Simulator developed by researchers at Clemson University is being used to investigate the effects of different UKA alignment and ligament configurations on the movement and contact pressure distributions on the knee.In an effort to investigate the effects of different unicompartmental knee arthroplasty (UKA) alignment and ligament configurations on the movement and contact pressure distributions on the knee, researchers at Clemson University (Clemson, SC) have designed and constructed a knee...