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From Medical Design & Outsourcing

• Australian TGA to handle medical device advertising complaints
  By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) plans to roll out “simplified and improved arrangements” for managing complaints regarding medical device and drug advertising. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
• GVS buys Kuss Filtration
  Microfiltration company GVS announced today that it has entered an agreement to acquire Kuss Filtration from Industrial Opportunity Partners. The financial details of the deal were not disclosed. Under the terms of the acquisition, GVS and Kuss will work together to enter the micro filtration and automotive markets. “GVS has high expectations for this new […]
• 8 ways 3D printing is making surgery remarkable
  3D printing is already making a difference in healthcare: It enables models of organs to train surgeons and educate patients –and improve surgical outcomes. Doctors previously had to examine actual organs with their hands to get a feel for what they need to do surgically. Now, MRIs and 3D printers eliminate the need to put […]
• Medical device R&D investments expected to rise through 2018
  By Stewart Eisenhart, Emergo Group An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
• China FDA issues draft guidance on clinical evaluation of some IVD reagents
  Grace Fu Palma, China Med Device China FDA recently issued a draft guidance document on clinical evaluation basic requirements for clinical exempt IVD reagents, along with a second batch of clinical exempt class II IVD reagents – 130 reagents – to the agency’s directory. Key provisions in the draft, issued May 24, deal with the […]
• GW Plastics acquires Ireland-based Avenue Mould Solutions
  GW Plastics said today that it has bought Avenue Mould Solutions, a precision mold building, machining, and injection molding company based in Sligo, Ireland. The deal enables GW Plastics to have precision mold-making and advanced manufacturing capabilities in North America, Asia and Europe. Financial terms of the deal were not disclosed. “GW Plastics is thrilled to […]
• This microscopy technique could create better biopsies
  Researchers are using high-resolution image biopsy samples to create more accurate and inexpensive diagnostic tests, according to the Massachusetts Institute of Technology. Light microscopes are usually used for pathology, but fine details of cells can’t be seen with them. The new technique, developed by Harvard Medical School and MIT, relies on expansion microscopy which expands […]
• Chinese regulators starting medical device clinical trial inspection program
  By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) plans to begin conducting on-site inspections of clinical trials for medical devices in an effort to improve clinical data used in premarket review decisions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
• Analysis: Robotic surgery will thrive in 3 major areas
  Global science, product and technology development company Sagentia claims that robotic surgery is going to continue to play an influential role in three niche areas including minimally-invasive surgery, specialist functional applications and patient management. The company predicts that continuum and snake robots will be beneficial to minimally-invasive surgical procedures because they are able to navigate […]
• Clinical evaluation reports and China: What you need to know
  Grace Fu Palma, China Med Device China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA submissions. 1. Summarizing data The CER must summarize the data from clinical literature, clinical experience, and clinical trials, etc. […]
• How Magnolia Medical is battling sepsis false-positives for better value
  Seattle-based Magnolia Medical Technologies – which says it makes a dramatic improvement to sepsis testing – provides a great example of the new value arguments dominating medtech. Sepsis happens to be a big deal. Hospital patients are often susceptible to sepsis, a bacterial infection that is the fifth leading cause of death. The standard of care […]