FDA authorizes Quest Diagnostics/3M “real-time” Swine Flu molecular test combo

From Medical Design & Outsourcing

• Cook Medical wins humanitarian nod from FDA for Flourish pediatric esophageal atresia device
  Cook Medical (Bloomington, Ind.) recently received authorization from the FDA under the Humanitarian Device Exemption for a pediatric esophageal atresia treatment device called the Flourish. The device is now available in the U.S. Esophageal atresia is a birth defect in the esophagus where the upper esophagus doesn’t connect to the lower part of the esophagus and… […]
• How researchers could mass produce organs-on-chips
  Harvard University researchers have developed a new method to making organ-on-chips to allow for rapid prototyping with reduced manual labor. The new protocol combines multi-scale patterning of organ chip parts into a single step, which in turn saves time, improves reproducibility and traceability and reduces the risk of contamination. “We hope this new protocol will… […]
• Diversified Plastics appoints new quality director
  Diversified Plastics recently appointed Gary LaTraille as its new quality director. He will be responsible for strategic advancement, optimization and enforcement of Diversified Plastics’s regulatory and quality protocols. LaTraille has over 30 years of experience in medical device manufacturing, quality management and regulatory compliance. Before Diversified Plastics, LaTraille was manager of quality assurance and regulatory… […]
• Saudi regulators adjust MDMA submission timeframe
  By Stewart Eisenhart, Emergo Group Medical device regulators at the Saudi Food and Drug Authority (SFDA) have updated deadlines for pending Medical Device Market Application (MDMA) submissions. 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 of… […]
• Union Bridge Holdings inks deal with APrevent Medical
  Union Bridge Holdings has signed a memorandum of understanding agreement with APrevent Medical (Feldkrich, Austria) for a potential share swap between Union Bridge and APrevent. APrevent Medical designs, manufactures and distributes medical equipment and is currently developing the Vocal Implant System and Intelligible Speak (AiSpeak). The Vocal Implant System is a laryngeal implant that is used… […]
• ivWatch signs Australian distribution deal
  ivWatch (Hampton, Va.) has signed a distribution agreement with New Medical as its distributor for the Australia and New Zealand markets. New Medical is a supplier of medical consumables, device and patient monitoring accessors. “Our entry into these markets is a response to growing awareness and clinical demand,” Scott Hensley, VP of sales and business… […]
• This tiny, chip-based device could transform spectrometry
  Massachusetts Institute of Technology researchers have developed a new inexpensive approach to making spectrometers, which could allow the devices to be mass produced for a number of new uses. Spectrometers distinguish different wavelengths of light and can be used to figure out the chemical composition of everything from laboratory materials to distant starts. The devices… […]
• UnitedHealthcare Motion uses Apple Watch to encourage physical activity
  Apple Watch is now a part of UnitedHealthcare Motion, a wearable device program that encourages people to walk 12,000 steps a day. The Apple Watch will be available to eligible employer-sponsored program participants, allowing people to use their existing Apple Watch or shop for a new one. One payment option allows participants to start using… […]
• Panasonic touts pin-type lithium-ion battery
  Panasonic has launched its pin-type lithium-ion battery model, the CG-425A. The battery has a nominal voltage of 3.8V with a typical capacity of 32.0 mAh. It has a diameter of 4.7mm and weighs about 1g without tabs. It is small and slim cylindrically shaped and is able to be rapidly charged. The battery’s stainless steel… […]
• NuVasive launches Brigade spinal implant
  NuVasive recently launched its Brigade Lateral inter body implant and instrumentation that is designed for lateral anterior lumbar inter body fusion (ALIF) spine surgery. The new spine procedure gives doctors access to the L5-S1 from a lateral position while retaining traditional ALIF characteristics. Brigade Lateral offers improved instrumentation, a new insertion method and an expanded… […]
• What a draft Brexit agreement means for the medical device industry
  By Ronald Boumans, Emergo Group British and European negotiators have reached a draft agreement concerning the withdrawal of the United Kingdom from the European Union (EU). 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 of MedicalDesignandOutsourcing.com… […]