• Cardiovascular Systems to Pay $8M to Settle Kickback Suit

    The company has agreed to pay millions over three years to settle a whistleblower lawsuit.Nancy CrottiIt’s the third blow in the past year for the New Brighton, MN–based company Cardiovascular Systems, Inc. In February, it disclosed in a regulatory filing that a shareholder class action lawsuit had been filed in U.S. District Court for the Central District of California against the company over the same allegations. That same month, it announced that David Martin had stepped down as CEO and...
  • Clinton Campaign Cancels Theranos Fundraiser, Relocates Event

    Mired in controversy, Theranos had planned on hosting a fundraiser for Hillary Clinton. The fundraiser was later moved to a private home.Qmed StaffTheranos CEO Elizabeth Holmes was featured at a Clinton fundraiser in Palo Alto, which was held at a private residence. Earlier reports suggested that the event would be held at a Theranos facility. Chelsea Clinton is shown on the right. Image from Ruby Cramer's Twitter feed. Media reports had been speculating why the Clinton campaign would agree to...
  • Johnson & Johnson Unveils Plan to Boost Its Medtech Segment

    The healthcare conglomerate has identified six business niches segments to invest in to boost its medical device segment.Brian BuntzJohnson & Johnson has seen the profitability of its consumer-product and medical device sectors flag in recent years, prompting activist investor Artisan Partners Limited Partnership to pressure the firm into spinning off those business units.The company’s executives recently shared their vision for growing its medical device business with a six-pronged plan...
  • FDA Considers Banning Powdered Surgical Gloves

    The agency has a proposal to ban most powdered medical gloves to protect patients and healthcare professionals.Brian BuntzOn March 21, FDA announced a plan to ban the majority of powdered gloves in the United States stating “they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them.”The move would apply to powdered surgeon’s gloves and examination gloves, which are regulated as Class I–medical devices.One...
  • How Light Might Prevent Cancer

    Light stimulation in conjunction with gene therapy has shown promise in research on frogs. Kristopher SturgisBiologists from Tufts University have demonstrated the possibility of treating and preventing the formation of tumors.The group demonstrated the effects of optogenetics when they injected the embryo cells of a frog with RNA encoding mutant oncogenes — genes that, under certain circumstances, can transform into a tumorous cell. Next, they activated either a blue-light for a positively...
  • Brain-Zapping Headphones Hit the Market

    Two startups have recently launched brain-stimulating headphones. One claims that its headphones will improve athletes’ ability to work out while the other claims that their product will lift users’ mood. Neither product is technically a medical device. Brian BuntzA growing number of startups are hoping that transcranial direct current stimulation will be the next frontier in wearables.One of the entrants in this field, Halo Neuroscience (San Francisco) says its brain-stimulating headphones can...
  • Introducing 'Salt' MRI Scans

    A British research institute has developed an MRI scanning technique that can identify sodium concentrations in the body to help detect disease.Brian BuntzBy tracking sodium concentrations in the body with MRI, researchers hope to advance the scientific understanding of kidney disease as well as understanding how sodium management occurs in the brain, lung, liver, and musculoskeletal system. Sodium plays a significant role in cellular function and some diseases can cause irregularities in how...
  • Novel Gel Boosts Blood Flow in Patients with Arterial Disease

    An injectable gel derived from the natural scaffolding in human muscle holds promise for treating arterial disease, say engineers at the University of California, San Diego.Kristopher SturgisThe tissue from skeletal muscle of pigs suspended in detergent eventually yields fibrous extracellular matrix remains for injection. A new treatment could be used to treat poor blood circulation caused by advanced peripheral artery disease, a condition that can lead to infection and limb amputation.The...
  • New Shapeshifting 3-D Material Could Make for Better Stents

    Harvard University researchers developed a new, flexible, versatile material, which can be fine tuned to change its size and shape to adapt to different environments.Kristopher Sturgisvia GIPHYThe new material is a structure made of thin walls that can be folded, molded, and reshaped. The result is objects whose size, volume, and shape can be altered to form any number of architectural structures or objects.\Harvard researchers and engineers created the material with a composition that can...
  • Meet the BIOMEDevice Boston Innovation Prize Finalists

    An affordable professional-grade 3-D printer and easily customized medical device motors are among the exhibitor innovations that will compete at the April 13–14 show in Boston.Chris NewmarkerVisit BIOMEDevice Boston and help us pick the BIOMEDevice Boston Innovation Prize winner among these five finalists, gleaned out of a group of 10 semifinalists. (The Innovation Tour to pick the winner will depart from Center Stage at 1 p.m. on Wednesday, April 13.) The...
  • The 10 Most Innovative BIOMEDevice Boston Suppliers

    An affordable professional-grade 3-D printer and an automatic interactive quoting system for prototyping are but some of the innovations among the 10 BIOMEDevice Boston Innovation Prize semifinalists. Help us pick the five finalists that will compete at the April 13–14 show.Chris NewmarkerMotors, operating systems, cables, coatings, 3-D printers, software—there are many innovations to be had on the floor of a major UBM medical device show such as BIOMEDevice Boston. Any one of them could...
  • The Top 10 510(k) Trends Since 2000

    Although the average time for FDA to clear a 510(k) application has been trending down in recent years, it had increased by 60% from 2000 to 2010, increasing from an average of 96 days in 2000 to 154 in 2010. Interestingly, the FDA’s data indicates that the delay was largely a result delays on the part of the submitter. Brian BuntzThe clearance process, established under the Medical Device Amendments of 1976 and reformed in the 1990s, provides a way for medical device manufacturers to get to...
  • 4 Ways You Can Design Mobile Health's Future

    Imagine a time when tailored and actionable health advice is immediately available on our smart devices. Here are four design principles that could help get us there, courtesy of insights and strategy company Artefact.Chris NewmarkerHow can we create mobile health that truly provides meaningful insights? Design firm Artefact thinks it has hit on some answers with its Chronicle concept. (Image courtesy of Artefact)Picture a person with chronic obstructive pulmonary disease going for her...
  • How Krypton Could Make for Better MRI Lung Images

    UK researchers take MRI imaging to the next level with a new scanning method that provides high resolution images of lung disease and pulmonary tissue. Images produced by the new technique (Courtesy of University of Nottingham)Kristopher Sturgis The new imaging technique  uses specially treated krypton gas that can be inhaled and used as a contrast agent to reveal new areas of the lung on an MRI scan. The new process was developed at the Sir Peter Mansfield Imaging Center at the...
  • Engineers Create Living Tissue From 'Human-On-A-Chip' Technology

    The new technology could serve as a platform for growing human tissue outside the body that could eventually be used to repair or replace failing human organs.Kristopher SturgisA platform known as AngioChip could take tissue engineering to new heights as a group of researchers from the University of Toronto have created a new unique method for growing human tissue in a lab in conditions that can mimic the human body. Their design was modeled after electronic microchip technologies that carry...
  • Pelvic Mesh Maker: Women had Unnecessary Surgeries for Profit

    The medical device company AMS had agreed to pay $1.6 billion to settle lawsuits over its vaginal mesh products. But now it is fighting back, claiming in court that there were plaintiffs who had unneeded surgical procedures to drive up settlements against mesh companies. AMS is also subpoenaing some of the law firms involved in the litigation. Brian BuntzAmerican Medical Systems (AMS), a urology company that made vaginal mesh, is striking back after announcing in 2014 that it would pay $1.6...
  • FDA Clears Parker Hannifin Exoskeleton for Personal and Clinical Use

    Parker Hannifin says that its FDA clearance will give 270,000 people with severe spinal cord injuries the opportunity to walk again. Convincing payors to cover the device, however, could be a challenge. Brian BuntzParker Hannifin Corp. has convinced FDA to clear its 26-lb. exoskeleton, which could be used to treat up to 1.7 million people in the United States—including more than a quarter-million people with severe spinal cord injuries. There are roughly 12,500 new cases of severe spinal injury...
  • Apple Invents Emergency Alert System

    Apple has filed a patent for a medical monitor that can sound an alert based on irregularities in a user’s temperature, heart rate, oxygen level, or blood pressure.Brian BuntzIn its patent filing with the U.S. Patent & Trademark Office, Apple states that the device can detect “care events” and sound alerts in the case of medical emergencies such as a heart attack or a fall. In addition, the device could alert family or police of events such as car crashes, bike accidents, a mugging, or the...
  • Q&A: Meet the Developer of a Wristband That Detects Seizures

    A research project related to detecting emotions in people with autism eventually found use for helping epileptics.Qmed StaffThe wearables of the future can do a lot more than track steps. A number of startups and university researchers are working on developing clinically relevant wearables that can do everything from monitor hydration to blood pressure to detect medical problems such as seizures. To learn more about the latter, we reached out to an MIT researcher who has helped develop a...
  • Wrist-Worn Wearable Can Detect and Maybe Prevent Seizures

    A wristband can monitor stress signals in epileptics to detect and warn of impending seizures.Kristopher Sturgis A new device, known as Embrace, is the product of a new company called Empatica— an organization that specializes in the development of wearable devices using medical quality sensing technologies. The project was aimed at providing a novel tool for patients who suffer from epilepsy, a neurological disease that is characterized by unprovoked seizures that can lead to a fatal...