From CHF Solutions’ new Italian distribution deal to Masimo’s CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. CHF Solutions signs Italian distribution deal CHF Solutions announced in an April 17 press release that it has signed a new distribution agreement with TRX Italy to distribute […]
10 BIOMEDevice Boston exhibitors you need to know
BIOMEDevice Boston is an opportunity for more than 4,000 engineers and executives and 400 suppliers in New England’s design and manufacturing industry to connect and network. The annual event is being held at the Boston Convention and Exhibition Center, April 18-19. Hundreds of supplier booths will be showcasing their latest technologies and capabilities. Here are 10 […]
FDA enhances the transparency of clinical trials
Ashton Steinhagen, lead clinical research associate, IMARC When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic. […]
Health Canada launching new unit for digital health technology licensing
By Stewart Eisenhart, Emergo Group Medical device regulators at Health Canada are developing a more targeted oversight approach for digital health technologies such as mobile medical applications. 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 […]
What is the future of harmonized standards?
Nele Zgavc, BSI Group For national standards bodies, 2018 brings a big challenge as we aim to generate appropriate revisions of key standards that manufacturers use to show compliance to essential requirements. These harmonized standards include an Annex ZA/ZZ which represents the correlation between the requirements in the EU Medical Devices Directives (MDD, AIMD, IVDD) […]
This visor-like device could be a defibrillator for stroke
A portable, visor-like device has shown potential for detecting emergent large-vessel occlusion with 92% accuracy in patients who may have had a stroke. The researchers suggest that the diagnostic device could be readily accessible to emergency personnel and in public spaces in the same way a defibrillator is available for treating heart attacks. Researchers and […]
What Brexit withdrawal means for MDR implementation in the U.K.
By Ronald Boumans, Emergo Group Negotiators discussing how the UK will leave the European Union have reached a draft Withdrawal Agreement about the transition period. The transition will start on March 29, 2019 and will end on December 31, 2020. Instead of 12 months from now, there are 21 months to prepare. This is still […]
This fluorescent dye could create clearer biological imaging
Massachusetts researchers have repurposed a commercially-available dye that has been around since the 1950s to make short-wave infrared easily available for clearer imaging. Fluorescence imaging is often used to visualize biological tissues or blood vessels during reconstructive surgery to see if vessels are connected properly. Currently, researchers use a dye that runs at the near-infrared […]
How GDPR affects personal data use in clinical trials
Lisa Wickert, Clinical Research Associate, IMARC On May 25, the General Data Protection Regulation (GDPR) goes into effect in the European Union (EU). This regulation has a broad scope beyond companies performing clinical research – all personal data falls under this jurisdiction which includes web search engines, social media, and much more. But specifically, how […]
Trump tariffs would take a $5B bite out of the medical device industry
The U.S. medical device industry could come out as a major loser if the Trump administration ends up fighting a trade war with China, according to experts following the situation. Out of the $50 billion in tariffs against imported Chinese goods that the U.S. Trade Representative is proposing, $5 billion involves medical device and technology […]
7 medtech stories we missed this week: April 6, 2018
From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow […]
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