Windgap Medical last week announced a strategic partnership with ALK-Abelló to commercialize its epinephrine auto-injector to treat anaphylactic shock. ALK will have exclusive, worldwide sales and distribution rights for the Windgap epinephrine auto-injector through the deal in exchange for technical and sales milestone payments and tiered royalties on net sales in the U.S. The companies […]
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 […]
Chinese regulators preparing medical device UDI pilot
By Stewart Eisenhart, Emergo Group The National Medical Products Administration (NMPA), China’s medical device market regulator, has begun laying the groundwork for a Unique Device Identification (UDI) pilot program scheduled to run through July 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Delcath Systems closes $20m private placement
Delcath Systems (OTC:DCTH) last week said that it closed a $20 million private placement round for the liver cancer treatment it developed. The Queensbury, N.Y.-based company priced the round at $1,000 per unit, with each unit consisting of a preferred convertible share worth 16,667 common shares, at a 6¢ strike price, and a five-year warrant another […]
European Notified Body capacity update ahead of MDR, IVDR and Brexit
By Ronald Boumans, Emergo Group The European Notified Body (NB) landscape remains in uncertain territory as additional entities opt-out of designation to the Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR), with ongoing lack of resolution regarding Brexit continuing to have an impact as well. Get the full story here at the Emergo […]
European Commission clarifies medical device vigilance requirements
By Stewart Eisenhart, Emergo Group The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD). 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 […]
Teva wins FDA approval for AirDuo Digihaler for asthma
Teva (NYSE:TEVA) yesterday said that it received FDA approval for its AirDuo Digihaler Inhalation Powder. The Israel-based company’s AirDuo Digihaler is a combination therapy digital inhaler with built-in sensors that can connect to a smartphone application, indicated to treat asthma in people 12 years and older.. It delivers a multi-dose dry powder of 113mcg of fluticasone […]
How human factors validation investigators identify user groups and populations
By Ella Engels, Emergo Group Imagine you are preparing for a human factors (HF) validation study to bring your medical device to market, and the market research recruiters inform you that it will be very challenging, if not unfeasible, to recruit the required 15 participants per user group. What do you do? Get the full […]