We're excited to share this month's edition of the NyquistAI newsletter, featuring the latest information about global clinical, regulatory and business insights uncovered by our Generative AI and a team of domain experts.
In this newsletter we'll share:
NyquistAI Insights: Global data and intelligence from our platform
Upcoming Webinar: Unlocking EU MDR - August 23rd @ 12pm ET
News highlights from July: AI-enabled devices and news from China
Product highlight of the month: FDA Guidance Search
Use case spotlight: Understanding the competitive landscape
NyquistAI Insights
July 2023 Additions Worldwide
Upcoming Webinar! Unlocking EU MDR
Join us on Wednesday, August 23rd to discover the latest updates on MDR and learn how AI can assist you in seamlessly maneuvering through the EU MDR process, enabling you to focus on what you do best – advancing healthcare for patients.
According to the FDA, there are 521 approved devices with AI components, and this list is updated only periodically. The NyquistAI platform currently has 632 devices with AI components that have been approved in the US, along with an additional 84 in Europe, Japan, China, and other regions.
The surge of AI/ML-enabled medical devices is just beginning, and having access to the most comprehensive compilation of approved devices will provide significant advantages. For existing NyquistAI users, you can access the up-to-date list of AI-approved devices by following link: https://product.nyquistai.com/ai/devices.
More "Geenlight" from China: 1,025 Medical Devices Exempted from Clinical Trials in China
In the last issue, we did a quick recap of all the multinational CEOs visiting China and got positive feedback from readers, so we want to share with you the latest news from the largest emerging market.
Recently, the China FDA announced the issuance of a catalog of medical devices exempted from clinical evaluation (source). This policy change is driven by the desire for better regulation. Medical devices with clear mechanisms, standardized product design, mature production, and similar products already approved on the market for many years without major adverse events and recalls will be exempted from clinical trials.
Will this new policy open up the Chinese market for your established products? Feel free to reply to continue the conversation.
NYQUISTAI PRODUCT HIGHLIGHT
Nyquist AI’s FDA Guidance Search
The FDA only returns results if your search terms are in the title. Our new ‘Guidance’ feature allows you to search the full text of all FDA guidance documents. You can also set up alerts to stay on top of new guidance.
Researching and reporting on the competitive landscape of devices is time consuming, inefficient, and often relies on your own prior knowledge of the space for completeness.
SOLUTION
Using Nyquist AI, you can efficiently evaluate the device landscape by searching on device indications or description and filtering by a variety of characteristics.
The platform uses AI to suggest similar devices, leveraging over a billion data points, and surfacing devices that may have been overlooked by traditional methods (i.e. those outside of the product code).
NyquistAI’s document writer can employ templates to quickly summarize devices of interest.
VALUE
NyquistAI enables you to understand and summarize the competitive landscape of devices in a fraction of the time of traditional methods. You can be confident that you’ve found all the information you need to present the whole picture and make strategic decisions.
Our mission is to make unstructured data and institutional knowledge easily accessible to help our clients accelerate groundbreaking discoveries in human health. As always, we value your feedback and welcome any suggestions or topics you would like us to explore in future editions.
Big hugs from sunny Palo Alto,
NyquistAI Team
Interested to see how NyquistAI can give you a competitive advantage in 2023?
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