By Ronald Boumans, Emergo Group On July 5, the Dutch Ministry of Health organized an informative meeting for the medical field about the possible impact the UK’s exit from the European Union (EU), Brexit, might have. This is considered a very important issue that may impact many aspects of the Dutch – and European – […]
9 trends in medical device user interface design
By Valerie Ng and Jon Tilliss, Emergo Group As the influence of technology in our everyday lives continues to grow, the standard for aesthetically pleasing and contemporary user interface (UI) designs in the healthcare space continues to evolve. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Siga wins FDA nod for oral smallpox treatment
Siga Technologies (NSDQ:SIGA) today won FDA approval for its oral formulation of tecovirimat as a treatment of smallpox in the case of a potential outbreak. The drug is designed to mitigate the impact of a potential bioterrorism attack, according to the New York-based company. Siga also touted that the FDA granted its request for a priority […]
Medtech stories we missed this week: July 13, 2018
From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump […]
South Korea changes guidelines for medical device cybersecurity management
By Stewart Eisenhart, Emergo Group In a sign that medical device market regulators are moving toward a uniform approach to cybersecurity risk management, the South Korean government has published new guidelines referencing the UL 2900 cybersecurity standard as well as US Food and Drug Administration recommendations. Get the full story here at the Emergo Group’s […]
Key questions for the role of post-market surveillance in European MDR
By Mark Leimbeck, Emergo Group Manufacturers are beginning to take action with respect to the European Medical Device Regulation (MDR), including the Regulation’s new approach to post-market surveillance, or PMS. 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 […]
Companion Medical wins FDA nod for Android version of smart pen app
Companion Medical said today that it won FDA clearance for the Android version of its InPen app. The company’s InPen system consists of a smart insulin injection pen that connects with an integrated diabetes management app. Companion Medical expects to release the app for Android users by the fourth quarter of this year. “We are […]
MDR and IVDR publication requirements for user information on medical device manufacturer websites
By Ronald Boumans, Emergo Group Section 23.1 of Annex I of the Medical Devices Regulation (EU) 745/2017 (MDR) and section 20.1 of Annex I of the In-Vitro Diagnostic Medical Devices Regulation (EU) 746/2017 (IVDR) pertain to requirements that looks quite simple: If the manufacturer has a website, it must publish the user information (label, instructions […]
Saudi regulators revise medical device shipment requirements
By Stewart Eisenhart, Emergo Group The Saudi Food and Drug Authority (SFDA) has published revised requirements for clearing imported medical devices at Saudi ports of entry. 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 […]
Ocular Therapeutix resubmits NDA for ocular pain relief implant
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a new drug application for its Dextenza ocular pain relief implant to the FDA. The Bedford, Mass.-based company noted that the resubmitted application aims to address manufacturing deficiencies highlighted by the FDA last year when the agency rejected Dextenza for the second time. Ocular Therapeutix’s Dextenza device is designed to […]
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