Companion Medical started selling its smart insulin pen in the U.S. today, according to the San Diego, Calif.-based company. The InPen system, which combines an insulin injector pen and a smartphone app, is compatible with Eli Lilly‘s (NYSE:LLY) Humalog and Novo Nordisk‘s (NYSE:NVO) Novolog fast-acting insulin. Get the full story at our sister site, Drug Delivery Business News.
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By Michael Wiklund, Emergo Group Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim. Get the full story here at the Emergo Group’s blog. The opinions expressed in this
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Opioid-related deaths have become an epidemic in the US, garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from a drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause
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GE Healthcare (NYSE:GE) and healthcare provider Lifespan said this week they inked a collaborative deal as Lifespan looks to use GE’s services and systems to reduce its costs by approximately $182 million while improving patient care. Through the deal, which is slated to cover six years, GE Healthcare will aid Lifespan in improving patient flow, increasing
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A panel of experts from the European Medicines Agency issued a positive recommendation today for Novo Nordisk‘s (NYSE:NVO) once-weekly diabetes drug, Ozempic. The committee’s recommendation will need to be endorsed by the European Commission before the insulin-maker’s product can be formally marketed in the EU. Get the full story at our sister site, Drug Delivery Business News.
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California researchers have discovered that the immune system’s response after a heart attack plays a significant role in what happens following a heart attack. Following a heart attack, heart cells begin to die, causing the immune system to send immune cells into the dead tissue to clear debris and start stabilizing the heart wall. University
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A patient at the Rambam Medical Center in Israel was recently implanted with a polymer-made ballast that was originally designed for NASA. Roxana Smarsky has a disease that causes the head of her femur to contract. She recently had to have orthopedic surgery to replace her hip that was worn and causing pain because of
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Researchers in Switzerland are using electric currents to map the distribution of biomolecules in cancer cells to give doctors a better understanding of which therapies would be most effective for treating cancer. Traditionally, fluorescent markers are used to gather spatial information about cancer cells to targeted therapies. École Polytechnique Fédérale de Lausanne and Linkou chang
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A new report from Discern Health and supported by industry group AdvaMed claims that current value-based payment models lack quality measures which effectively assess medical technology value. In the report, investigators identified what they claimed to be “significant gaps” in eight clinical areas it studied that included medical devices indicated to treat those conditions. Report […]
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The Echo prosthetic leg is specifically designed to improves a dog’s mobility and balance, giving them a second chance at life while reducing pressure on his body and avoiding potential spinal issues. Model Solution (Milpitas, Calif.) assisted Shubham Harish, a student at the College for Creative Studies in Detroit, in developing the design for the canine
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By Stewart Eisenhart, Emergo Group A new set of critical infrastructure security recommendations from European regulators targets the Internet of Things (IoT), with significant implications for medical device manufacturers and health technology developers’ cybersecurity risk mitigation efforts ahead of a major data protection compliance deadline in 2018. Get the full story here at the Emergo
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The Ohio State Wexner Medical Center is using a new procedure to help patients avoid hip replacement surgery while still repairing their hip. The procedure, called Subchondroplasty, involves injected a bone substitute material into the hip joint. The material helps fill voids or lesions in the joint. “We want to preserve the native hip whenever
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Charlotte Morello, Novasyte Health Product recalls happen. Even to the most diligent organizations. With the medical device landscape continuously evolving, organizations must be agile and ready to respond to a recall at any moment. In looking at the annual number of medical device recalls in the graph below, one thing is known – recalls are
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AdvaMed CEO Scott Whitaker has penned a letter to President Donald Trump, urging the president to work with Congress to overturn the medical device tax. Whitaker in his letter today congratulated Trump on today’s passage of the Republican-backed tax plan, while noting that Congress has failed to suspend the 2.3% levy imposed on U.S. medical
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Some of the largest medtech companies showed in 2017 that they are ready to grow through embrace the new healthcare ecosystem. Medical device companies are putting greater emphasis on value-based. They’re putting more attention to clinical and economic research and adopting digital products that incorporate machine learning and data integration. Questions, though, still remain as
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Gynesonics announced that it has submitted its 510(k) Premarket Notification to the FDA for its Sonata System. The Sonata System is a uterus preserving, incision-free uterine fibroid treatment that was designed to treat fibroids transcervically with radiofrequency energy. “Submission of the 510(k) application is an important milestone for our company,” Chris Owens, president and CEO
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Modern medicine is revolutionary in comparison to how different diseases and disorders were treated in ancient times. Without regulation, its no surprise that methods like drilling a hole in the skull to relieve a headache and using enemas to treat asthma were normal practice. With the FDA’s founding in 1906, many devices and practices have
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Roald Dahl is best remembered as an author of children’s books, particularly for works like Charlie and the Chocolate Factory and Matilda. His stories have sold more than 250 million copies around the globe. But Dahl was much more than a storyteller: He also helped invent a medical device that has been used on nearly 3,000 children worldwide, according
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The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. Here are seven stories that mattered for the medical device industry this year. Next>>
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Charlotte Morello, Novasyte Health A global healthcare organization had multiple nationwide recalls with over 1.8 million units in 2,500 facilities. Facing internal bandwidth constraints, Novasyte was hired as the partner-of-choice to manage the recall execution. Goals The customer’s goal was to complete the following tasks as quickly as possible. Notifications: 100% notification attempts, as per
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