Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]
China CMDE publishes generic medical device names guidance
By Timothy Herr, Emergo Group China’s Center for Medical Device Evaluation (CMDE) published Announcement No. 99 of 2019, a guidance document intended to clarify the principles employed by the National Medical Products Administration (NMPA) for determining medical device generic names. This expands upon the rules previously outlined in CFDA Order No. 19. (The China Food […]
Singapore HSA revises guidance and technical reference documents
By Timothy Herr, Emergo Group On February 17, Singapore’s Health Sciences Authority (HSA) published a number of revised guidance and technical reference documents. 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 DrugDeliveryBusiness.com or its employees.
Health Canada implements electronic medical device clinical trial data submission
By Stewart Eisenhart, Emergo Group Health Canada, Canada’s medical device market regulator, has begun accepting some clinical trial-related information from sponsors via electronic 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 DrugDeliveryBusiness.com or its […]
Meridian Medical Technologies recalls EpiPen and EpiPen Jr auto-injectors
Meridian Medical Technologies issued a voluntary recall for 13 lots of the Mylan EpiPen and EpiPen Jr. Auto-Injectors. The recall stems from the potential of the devices to contain a defective part that could result in the devices’s failure to activate. The company says the number of reported failures is small, but the defective part […]
Eitan Group appoints new Q Core Medical CEO
Eitan Group today said it appointed Igal Shany as CEO of its Q Core Medical and president of Eitan Group. Shany has previously served on the board of directors for Q Core and sites on the board for Eitan’s other infusion companies Sorrel Medical and Avoset Health. “I’ve had the pleasure of working with Eitan […]
This coin-sized smart insulin patch could monitor glucose for diabetes management
Researchers at three universities have developed a smart insulin-delivery patch that has the potential to also monitor and manage glucose levels in people with diabetes. The adhesive patch was developed by a team of researchers and bioengineers from UCLA, the University of North Carolina School of Medicine and the Massachusetts Institute of Technology. It is […]
Lantheus names new chief commercial officer
Lantheus today said it appointed Paul Blanchfield as chief commercial officer, effective immediately. Blanchfield will report to president and CEO Mary Anne Heino. “With his extensive operational experience and deep expertise in commercializing rare disease products, Paul will be a valuable addition to our executive leadership team as we execute our long-term growth strategy,” Heino […]
Smith & Nephew acquires Tusker Medical
Smith & Nephew (NYSE:SNN) today said it acquired Tusker Medical for an undisclosed amount. Tusker Medical develops the Tula System, which is an in-office ear tube delivery system to treat recurrent or persistent ear infections. The pediatric ear tubes won FDA breakthrough device designation in November last year. “The Tula System is a truly innovative option for physicians […]
Medtronic launches data management software program for Synchromed II
Medtronic (NYSE:MDT) this week launched a cloud-based data management software platform for its Synchromed II drug delivery system. The Efficio platform is designed to allow clinicians to manage targeted drug delivery pump practices to treat patients who have chronic pain, cancer pain and severe spasticity. It consolidates, organizes and provides visual summaries of patient data received […]
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