By Ronald Boumans, Emergo Group DEKRA Certification GmbH, NB number 0124, is now designated for the Medical Devices Regulation (EU) 2019/745 (MDR). 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.
Medtronic wins FDA approval for new extended-wear infusion set
Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set. The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more than twice the amount of time any infusion set can currently […]
Novocure’s Optune wins innovative medical device designation from China
NovoCure (NSDQ:NVCR) said today that it was granted Innovative Medical Device Designation in China for its Optune tumor treating system. The Optune system uses electric fields that are tuned in to specific frequencies to disrupt cancer cell division, according to the company. The technology inhibits tumor growth and causes cancer cells to die. Zai Lab has […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
Australian TGA issues final guidance on medical device and IVD cybersecurity
By Stewart Eisenhart, Emergo Group Australia’s Therapeutic Goods Administration (TGA) has implemented final guidance on pre- and post-market cybersecurity regulatory recommendations for medical device, software and IVD manufacturers and sponsors. 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 […]
New European MDR guidance on medical device implant cards
By Ronald Boumans, Emergo Group The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards, assisting in understanding article 18 of the Medical Devices Regulation (EU) 2017/745 (MDR). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Brazil regulators require electronic submission of medical device FSCAs
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has begun requiring manufacturers and sponsors to provide field safety corrective action information via an electronic petitioning system. 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 […]
Acorda’s Parkinson’s device moves closer to E.U. approval
Acorda Therapeutics (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are […]
FDA approves delivery system for Intersect ENT’s Propel implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for a new delivery system for its Propel Mini steroid-eluting sinus implant. The Menlo Park, Calif.-based company said the straight delivery system is designed to place the mometasone furoate-eluting Propel Mini in the ethmoid sinus behind the nasal bridge. The SDS is slated to hit […]
Eli Lilly, Aptar win FDA approval for nasal glucagon powder
Eli Lilly (NYSE:LLY) and AptarGroup (NYSE:ATR) today won FDA approval for the first injection-free glucagon for treating severe low blood sugar in diabetes patients. The federal safety watchdog’s approval, of Lilly’s Baqsimi nasal powder and the delivery device developed by Aptar for treating severe hypoglycemia, was based on two studies comparing a single dose of Baqsimi […]
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