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From Medical Design & Outsourcing

• What medtech’s top executives learned from their dads
  For better or worse, parents including dads play a major role in who we become. As we approach Father’s Day in the U.S., Medical Design & Outsourcing and MassDevice reached out to some of medtech’s top executives to ask what they learned from their dads. Here’s what they said: “My father built a business in… […]
• FDA issues docs on medtech remanufacturing, servicing
  The FDA has issued two documents to help distinguish between remanufacturing and servicing of medical devices. One is a draft guidance written to clarify the activities that likely constitute the remanufacturing of a device. The other is a discussion paper on cybersecurity and medtech servicing. The guidance also describes the FDA’s current position on remanufacturing,… […]
• HelixBind wins $3M grant for sepsis test
  HelixBind announced today it has landed a $3 million federal grant to help develop a test to diagnose bloodstream infections associated with sepsis. The FDA granted Breakthrough Device Designation to the RaPID/BSI test and platform in 2020. Boxborough, Mass.-based HelixBind’s RaPID platform can provide definitive identification and characterization of infections directly from a blood draw… […]
• Supreme Court upholds Affordable Care Act again
  The U.S. Supreme Court has turned back a third Republican challenge to the Affordable Care Act (ACA), this time by a 7-2 vote. The latest challenge to the law popularly known as Obamacare came from Texas and other states, backed by the administration of former President Donald Trump. The justices ruled that the challengers lacked… […]
• New monitor could diagnose pregnancy complications
  Researchers at the National Institutes of Health (NIH) have developed a prototype device that could potentially diagnose pregnancy complications by monitoring the oxygen level of the placenta. The device sends near-infrared light through the abdomen to measure oxygen levels in the arterial and venous network in the placenta. The method was used to study the… […]
• Dabir Surfaces forges deal with Vizient
  Dabir Surfaces (Harwood Heights, Ill.) recently announced that it has landed a contract with group purchasing firm Vizient. Dabir also announced a deal with Premier this month.  The contract with Vizient, effective April 1, 2021, involves both OR products and patient care products. Dabir will provide powered overlay surfaces for patients at risk of developing pressure… […]
• Westfall Technik opens new medical molding plant in Chicago
  Westfall Technik announced that it opened a new facility near Chicago to boost its clean-room capabilities. Las Vegas-based Westfall said in a news release that it completely refitted a brownfield structure and opened it as a purpose-built, 40,000-square-foot facility with three Class 8-certified clean rooms and one white space certified for meeting Good Manufacturing Practices… […]
• JMI Equity invests $120M in Greenlight Guru
  Greenlight Guru announced that it has received a roughly $120 million investment from JMI Equity to support further development and sales growth for its medical device quality management software. The news comes half a year after Indianapolis-based Greenlight Guru launched its AI-powered Halo for Change Management, which provides recommendations of items impacted by a change… […]
• 3 things medical device companies should know about the Patent Trial and Appeal Board
  With nearly a decade of proceedings behind it, the Patent Trial and Appeal Board (PTAB) has established a record. Medtech companies can learn from it. Timothy P. McAnulty and Daniel F. Klodowski, Finnegan One of the key aspects of a strong patent is the owner’s ability to enforce it. And when a patent is asserted… […]
• MedTech Innovator selects 50 startups for showcase and accelerator program
  MedTech Innovator today revealed the 50 startups it selected to partake in its flagship showcase and accelerator program. The four-month program offers the startups visibility and access to leading manufacturers, providers, investors and other industry stakeholders, with up to $500,000 available in cash and in-kind prizes during the final competition at The MedTech Conference, powered… […]
• How Abbott engineered a catheter-delivered device for premature babies
  Abbott’s experience designing its Piccolo device provides essential lessons for medical device creators who want to spark a pediatric medical device renaissance. The Amplatzer Piccolo occluder from Abbott is one of the first medical devices that health providers can implant in premature babies weighing as little as 2 lb to treat patent ductus arteriosus (PDA)… […]