• Designing a Device for Drug Delivery? What You Need to Know about Extractables, Leachables, and Particles

    New expectations are evolving for particles and extractables and leachables.Daphne AllenGrowing demand for drug-delivery devices is bringing the pharmaceutical and medical device industries closer together. The risks posed by particulates and extractables and leachables, for instance, present challenges for both industries, so drug-delivery device designers and their pharma partners are encouraged to take a risk-based approach to testing. Standards bodies and industry groups are already working...
  • Has Mylan Paid Enough for Its EpiPen Mistakes?

    Mylan finalized a $465 million DOJ settlement in an effort to put its EpiPen drama in the rearview mirror.Amanda PedersenMylan CEO Heather Bresch said the company's finalized settlement brings closure for Mylan and its stakeholders. The $465 million settlement agreement that Mylan reached with the Department of Justice 10 months ago for claims that it defrauded the government by overcharging Medicaid for EpiPen auto-injectors has been finalized. Some called the news a win for taxpayers,...
  • FDA Clears Ortho Robotic Guidance and Navigation System

    Globus Medical has secured 510(k) clearance for its Excelsius GPS robotic guidance and navigation system, intended for use in orthopedic surgery and neurosurgery.Marie ThibaultAnother robotic surgery system is here.Globus Medical announced that FDA has cleared its Excelsius GPS robotic guidance and navigation system. The system, which also received CE Mark in January 2017, features an open design for use with Globus Medical implants and instruments.The platform will be used for orthopedic and...
  • Can Olympus Curtail This Device's Bad Rap?

    The company wants to study hysterectomy patients to show a revamped version of its power morcellator is safe and effective. But is the proposed study good enough?Amanda Pedersen  Olympus plans to study a containment device designed to prevent undetected cancer cells from spreading during gynecologic procedures that use the company's power morcellator. FDA cleared the PnemoLiner in April 2016. Power morcellators may never overcome the negative reputation they acquired a few years...
  • Two Companies Come Together on New Prosthetic Technology

    Coapt and WillowWood are developing a liner for upper extremity prosthetic devices that combines the benefits of interface and pattern recognition technologies.Kristopher Sturgis Coapt and WillowWood expect to release a new liner product for upper extremity prosthetic devices by 2018. Two prosthetic device makers have teamed up in an effort to make upper extremity prosthetic devices more comfortable. Coapt and WillowWood plan to collaborate on a new advanced liner...
  • AUVI-Q Named Official Epinephrine Auto-Injector of Minor League Baseball

    Partnership includes "peanut-free" games with in-park messaging.Daphne Allen AUVI-Q (epinephrine injection, USP), a past Medical Design Excellence Award winner, has just been named the “Official Epinephrine Auto-Injector (EAI) of Minor League Baseball.” The distinction is the result of a multi-year agreement between AUVI-Q’s manufacturer, kaléo, and Minor League Baseball (MiLB). AUVI-Q is an FDA-approved prescription medicine for treating life-threatening allergic reactions, including...
  • Q&A: Meet University of Minnesota’s Nanotech Expert

    James Marti, the senior scientist at the Minnesota Nano Center, speaks about some of the small but mighty materials that could lead to big advances in the medtech market.Kristopher SturgisWhen it comes to the future of medtech, there’s no denying that the impact that materials at the micro and nano scale will have on the development and functionality of next-gen devices will be significant. Within the realm of medtech, nanoparticles are expected to impact both the diagnostic and therapeutic...
  • Apollo Defends Obesity Balloon Following FDA Alert of Deaths

    After FDA alerted physicians that several patients have died soon after having an intragastric balloon placed in their stomach for obesity treatment, Apollo Endosurgery said its Orbera actually has a "very low mortality rate" of 0.01%.Amanda PedersenApollo Endosurgery said its Orbera balloon, approved by FDA in August 2015, has a mortality rate of less than 0.01%. Apollo Endosurgery CEO Todd Newton was not afraid to be blunt with investors Friday during a conference call to discuss a...
  • How Missile Defense Technology Is Fighting Cancer

    A missile defense algorithm developed for President Reagan's "Star Wars" program is used in the WATS3D biopsy system for detecting pre-cancerous esophageal conditions.Nancy CrottiA study found the WATS3D (Wide Area Transepithelial Sampling with 3D Tissue Analysis) system, made by CDx Diagnostics, to be four times more effective at detecting a pre-cancerous esophageal condition compared to the standard protocol.  A biopsy system that employs missile defense technology from President...
  • Could a Metal-Coating Process Help Both Manufacturers and Doctors?

    Fusing metal braids at their cross-sections on catheters offers a number of potential benefits.Daphne Allen Above: Various techniques from ProPlate. ProPlate, a provider of engineered metal coatings for medical device applications, will be highlighting its Torq-Lok metal-bonding technique for catheters at MD&M Minneapolis this fall.The company is known for its Vizi-Band process for adding radiopaque marker bands to medical devices through gold electroplating. “Our process has...
  • Are Weight-Loss Balloons Killing Patients?

    FDA is keeping tabs on two liquid-filled intragastric balloon systems used to treat obesity because at least five patients have died within a month of having the insertion procedure.Amanda PedersenReShape Medical's Integrated Dual Balloon System, approved by FDA in 2015, is one of two balloon-based obesity treatment devices that have been linked to recent patient deaths. FDA is keeping tabs on two liquid-filled intragastric balloon systems used to treat obesity after five patients died...
  • The Liquid Biopsy Surge Is Reaching Beyond Cancer

    p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 11.0px Helvetica} span.s1 {font-kerning: none} span.s2 {font-kerning: none; background-color: #fefefe} Investors just poured $50 million into a blood-based test for infectious diseases, developed by Karius Inc.Amanda Pedersen Liquid biopsy has attracted a surge of companies that are trying to change the way cancer is detected and monitored. But the benefits of this new type of technology can – and should – seep into other disease categories....
  • Could Hydrogel Solve a Major Medication Problem?

     Researchers from MIT created hydrogel-based capsules that can reside in the GI tract for up to nine days while releasing its medication — enabling more complex drug dose regimens.Kristopher SturgisJinyao Liu, left, and Giovanni Traverso, researchers at MIT and Brigham and Women's Hospital, developed a new set of hydrogel-based drug delivery materials designed to ensure patients receive their full course of treatment. These days when it comes to drug delivery, one of the biggest...
  • Medtronic Hits Illinois With Job Cuts

    The company is closing its distribution center in Joliet, IL, which will put 185 people out of a job.Staff Report Medtronic said it will lay off 185 people as it closes a distribution center in Joliet, IL. The company plans to close the facility by December in order to leverage other U.S.-based facilities and service providers, according to a Chicago Tribune report.The company said it told employees about the mass layoff in May and is offering severance and benefits, in addition to helping...
  • Can Veins-Turned-Arteries Save Blood-Starved Feet?

    LimFlow is touting recent results from a pilot study of its system, which is designed to switch blood flow from a blocked artery in the leg to a nearby vein to restore circulation.Nancy Crotti The LimFlow procedure uses two ultrasound-guided catheters, one venous and one arterial, to create an arterio-venous crossing. A stent is then used to connect the artery and the vein. Patients at risk for lower-limb amputation from advanced peripheral arterial disease (PAD) may have another...
  • How Stryker is Stepping Up Its Deformity Correction Game

    Stryker's new Hoffmann LRF Hexapod hardware and online application uses an advanced measurement tool that could take deformity correction to the next level.Amanda PedersenStryker's foot and ankle business recently launched the Hoffmann LRF Hexapod hardware and online application, which features an advanced measurement tool that uses a mathematical algorithm to calculate solutions to correct a deformity. The secret behind one of Stryker's newest products is a math. The company said its...
  • We Know Why Fresenius Wants NxStage, but Why Now?

    While the strategic rationale behind Fresenius Medical Care's $2 billion bid for NxStage Medical is clear, the timing of the deal is vague.Amanda Pedersen As Fresenius Medical Care kicked off a conference call Monday to discuss the company's plans to buy NxStage Medical for $2 billion in cash, it wasn't tough to guess the key question analysts would raise about the deal, which Fresenius expects to fund with debt."I'm sure it's on all of your minds," CEO Rice Powell said at the...
  • Partnering to Provide a Non-Opioid Pain Control Option for Orthopedic Patients

    New study shows decrease in opioid consumption.Daphne AllenDePuy Synthes and Pacira Pharmaceuticals Inc. are partnering to provide orthopedic patients long-lasting, non-opioid postsurgical pain control at the surgical site, and a recent study shows positive results.In the partnership, which was announced earlier this year, DePuy Synthes Sales and Pacira Pharmaceuticals are copromoting EXPAREL (bupivacaine liposome injectable suspension) exclusively in the United States. Indicated for...
  • Why Masimo Is on the Prowl for M&A

    The company's CEO recently told analysts that he wants to diversify the business through M&A to avoid "the Kodak movement."Amanda Pedersen Masimo Corp. CEO Joe Kiani is looking at a well-known camera company for a lesson on what not to do. "We want to create diversification for Masimo. ... I don't want the Kodak movement," Kiani said during the company's second quarter earnings call.While the comment was made in a joking manner, there is some truth behind it. Kodak's failure to...
  • Philips Nets $7.1M in Zoll Infringement Case

    A federal jury awarded Philips $10.4 million in damages from Zoll Medical Corp. in a patent infringement case but also ordered Philips to pay $3.3 million for its own infringement.Staff Report The expression "you win some, you lose some," seems like an apt description of a jury verdict in a long-running lawsuit between Philips Electronics and Zoll Medical.Both companies were found guilty of patent infringement in the case that involved three defibrillator-related Philips patents and...