• Designing a $93M Medical Technology: A Behind the Scenes Look

     The design firm Nottingham Spirk provides the inside scoop on how a sleek advanced cardiac mapping technology was developed starting from a crude prototype.Qmed StaffThe ECVUE vest can conform to a range of patient body types. In 2006, the startup CardioInsight (Cleveland, OH) was born with hopes of commercializing a new technology known as electrocardiographic imaging that had better resolution than traditional 12-lead ECG technology. The firm had secured considerable funding, which it...
  • Medtronic Questions Masimo Pulse-Ox Patents

    Medtronic had been paying Masimo royalties for two pulse-oximetry patents held by Masimo. Now Medtronic is questioning the validity of those patents with the Patent Trial and Appeal Board of the USPTO.Qmed StaffMedtronic has filed a claim with the USPTO’s Patent Trial and Appeal Board to challenge claims made in two Masimo patents. While Medtronic is now paying royalties to Masimo for the patents, Medtronic’s move indicate that it may stop doing so if the board supports its dispute.In total,...
  • Theranos' Partnership with Walgreens Could Be in Trouble

    A Wall Street Journal exposé on Theranos’ testing methods may have caused Walgreens officials and directors to reassess. Qmed StaffWalgreens is scrutinizing the Theranos blood testing technology it uses in Arizona pharmacies, and has no concrete plans to expand it into more Walgreens pharmacies, the Wall Street Journal reports, citing an anonymous Walgreens official. The news marks a stark contrast to the pharmacy’s original plan to eventually roll out Theranos technology in all of its 8200 of...
  • Why Size Matters When It Comes to Medical Devices

    A one-size-fits-all approach can be dangerous for certain implantable medical devices. Qmed Staff“If it doesn’t fit, you must acquit,” defense attorney Johnnie Cochran told jurors in 1995, referencing the infamous bloody glove that would not fit on accused murderer O.J. Simpson’s hand. While Simpson would later be found liable in a separate wrongful death suit, Cochran’s argument helped lead to a not guilty verdict in the case, often referred to as the “trial of the century.”Size can be a...
  • More Bad News for Breast Implant Company

    Sientra’s stock has slid more than 80% from highs of over $25 per share it hit this July and August. Now, the company has announced that a fire has hit one of its manufacturing facilities, operated by the Brazilian firm Silimed.Qmed StaffAn amateur picture from Whatsapp shows the Silimed fire. It’s shaping up to be a rough year for Sientra (Goleta, CA). Sales of the company’s products have been halted in the United States, Brazil, the United Kingdom, Australia, and other countries following an...
  • European Regulators Recommend Pulling Medtronic Implant from Market

    The European Medicines Agency (EMA) has announced that it is recommending halting the sale of Medtronic’s Inductos product. In the United States, the product is marketed as the Infuse Bone Graft, which has been the target of extensive litigation involving more than 1000 patients. An Infuse lawsuit may potentially be headed to the Supreme Court. Qmed StaffMedtronic InductosEuropean regulators have decided to recommend halting sales of the Medtronic Inductos product citing manufacturing problems...
  • How a Frankenstein Prototype Ended Up Being Worth $93M

    Decades ago, a Case Western Reserve University professor had the idea for a more-precise alternative to the EKG. The technology formed the basis for the company CardioInsight, which was acquired by Medtronic earlier this year. Brian BuntzThe CardioInsight ECVUE vest has sensors integrated through, probing the heart through a patient’s chest and back.While working a Case Western Reserve University, Yoram Rudy, PhD had the idea for a game-changing cardiac monitoring device—a vest filled with more...
  • Cardiac Company Turns to Bankruptcy

    Cardiac Science Corp., which makes automated external defibrillators, has filed for Chapter 11 bankruptcy protection.Nancy CrottiCardiac Science is a maker of defibrillators like this one. A new board of directors has taken charge of Cardiac Science (Pewaukee, WI), and has filed for bankruptcy protection to realign its business, restructure its debt, and prep for a sale of its business.The bankruptcy filing is marked by “corporate intrigue,” according to the Milwaukee Journal Sentinel, which...
  • Supremes Take Stryker Case against Zimmer

    The U.S. Supreme Court will decide whether Stryker Corp. will receive triple damages in a patent infringement suit against rival orthopedic device manufacturer Zimmer.Nancy CrottiA federal appeals judge ordered Zimmer in 2013 to pay $228 million to Stryker for infringing three patents in creating its Pulsavac Plus to remove organic debris from inside a patient during orthopedic surgery.U.S. District Court Judge Robert Jonker noted that while a jury’s original $70 million verdict “sounds...
  • Adverse Events Tied to First of Its Kind Spinal Device

    Imagine you are working beneath a car and the car jack suddenly fails. Expandable (or telescopic) spinal implants for anterior cervical corpectomy can be compared to a car jack—when they collapse in the cervical spine, the consequences can be grave, including neurocompromise, paralysis, and respiratory arrest. Qmed StaffA patent drawing for the X-CoreNuVasive recently announced that it has received the first 510(k) clearance for the X-Core Mini Cervical Corpectomy System, an expandable titanium...
  • Theranos Strikes Back against WSJ at WSJ Event

    Although $9B blood-testing firm Theranos has entered a “pause period” after a pair of Wall Street Journal articles questioned its technology, the company’s founder Elizabeth Holmes is seeking to restore the firm’s credibility by defending its technology and attacking the quality of the WSJ’s reporting.Brian BuntzElizabeth Holmes, the founder of Theranos, was slated to speak at a Wall Street Journal digital event known as WSJDLive held in Laguna Beach, and despite speculation to the contrary,...
  • Shocking Mental Disorders Into Submission

    Neurologists begin to explore targeted electrical brain stimulation to treat various mental disorders including obsessive compulsive disorder and even depression. Kristopher SturgisIn extreme cases, obsessive compulsive disorder (OCD) can be a very debilitating condition. Patients can spend hours repeating a task, cleaning their surroundings to exhaustion, or simply taking a shower. Various drug therapies can help patients manage the disorder, but few treatments actually eradicate symptoms...
  • Can Brain-Interface Technology Rehabilitate Paralysis?

    Brain-computer interface technology as a way to bypass spinal injuries — permitting paralyzed patients to move their limbs through the use of an implant in the brain.Kristopher SturgisElectrodes used to stimulate muscles and create movement.Doctors from Case Western Reserve University in Ohio have discovered a way to circumvent a paralyzed man’s spinal injury through the use of an implant that can collect signals in the brain, and convey them to electrodes embedded in the arm. The technology...
  • Theranos Turns to Silence as Controversy Unfolds

    The curious case of Theranos raises questions not only about the former media darling but also about the rules that allowed it to share so little data with government regulators.Nancy CrottiThe $9-billion Silicon Valley startup that promised to perform multiple diagnostic tests with a single drop of blood has gone silent after receiving scrutiny from FDA, the Wall Street Journal, and other media outlets. The Journal questioned the accuracy of the firm’s trademark finger-prick blood tests...
  • How Hackable Are Medical Devices?

    As greater wireless functionality is incorporated into medical devices, the risk of security problems increases.Brian BuntzJay RadcliffeIn 2011, the software security expert Jay Radcliffe hacked his insulin pump on stage at the Black Hat security conference in Las Vegas, demonstrating that a remote user could take control over the pump, potentially delivering a fatal dose of insulin. Radcliffe was a trailblazer in the field, advocating to both FDA and industry to help make devices safer. (...
  • New Exoskeleton Suit Aims to Help The Elderly Remain Active

    An international team of researchers have developed a portable robotic exoskeleton device that could serve as tool to help elderly patients remain active. The exoskeleton could make it easier for them to take walks, lift, and carry objects, and improve overall body movement. Kristopher SturgisA novel exoskeleton was developed using a diverse collection of advanced sensors to assist with various bodily movements, announced researchers at the Aalborg University in Denmark. The suit is equipped...
  • Minnesota Medtech Week Innovation Prize Finalists Announced

    With more than 462 votes in, our readers have selected the five finalists for the Minnesota Medtech Week Innovation Prize.Qmed StaffFrom a novel method of “printing” electronics to an affordable, professional-grade desktop 3-D printer, there will be an array of interesting technologies featured at the MD&M Minneapolis this year, held November 4–5. Read on to learn about the technologies that will be eligible for the Minnesota Medtech Week Innovation Prize.Read about the five finalists...
  • How to Pick Textiles for Implantable Devices: Infographic

    Biomaterials specialist Proxy Biomedical Ltd. put together this infographic, which details important considerations when selecting medical-grade textiles for implantable medical devices.Click to expand image
  • Laser Microfabrication Takes on Diagnostic Consumables: Part 1

    Advances in laser technology is leading to a wave of progress in diagnostic instruments. Glenn Ogura, Resonetics The trend to miniaturize diagnostic instruments leads to many benefits for patients and caregivers. It opens up opportunities for treating patients closer to the home. It simplifies testing by quickly putting the raw sample into the instrument and getting the result almost immediately, avoiding extra time to prepare the samples prior to testing. Miniaturized instruments also enable...
  • Theranos Under Fire after FDA and Press Scrutiny

    Theranos had been one of the hottest startups in Silicon Valley. Now the company is seemingly under attack, facing tough scrutiny from both FDA and several press outlets—most notably the Wall Street Journal.Qmed StaffOne of the hottest startups in Silicon Valley, Theranos (Palo Alto, CA) is in full-fledged damage control mode after scathing press it received from the WSJ and other press outlets. The Journal questioned the accuracy of the firm’s trademark finger-prick blood tests and, in its...