Streamlining MedTech Research

Here's what's in this month's newsletter:

• NyquistAI Insights: Global data and intelligence from our platform
• Product Highlight:?RWE Synthesis Made Easy
• Use Case Spotlight: Streamlining MedTech Research
• This Month in AI, MedTech, & Biopharma: FDA AI/ML Device Approvals: Strategies, Latest Updates, and Coverage Challenges?

Nyquist Insights

Jan-Apr 2024 insights from the NyquistAI data platform

To gain further insights like these and discover the full potential of our platform, schedule an introductory meeting with one of our product experts to learn more.

SCHEDULE AN INTRO CALL!

USE CASE SPOTLIGHT

Streamlining MedTech Research: Enhancing Predicate and Similar Device Discovery

PROBLEM

Regulatory Affairs (RA) professionals in the MedTech industry often face challenges when trying to discover predicate devices and identify similar devices for a specific indication. The current process, which involves extensive research through FDA websites (and sometimes Google), can be time-consuming and may not always yield comprehensive results, leading to uncertainty and potential risks in decision-making.

SOLUTION

NyquistAI’s “Device Explorer” and “Predicate Map” features provide innovative solutions to these challenges. The “Device Explorer” feature uses AI to effortlessly discover similar devices from various sectors that address the same indications based on the user’s input. The “Predicate Map” feature allows users to easily monitor and track devices by approval date, and with just one click, jump into each of those devices to see their predicate maps.

VALUE

The “Device Explorer” and “Predicate Map” features by NyquistAI streamline the research process for RA professionals, leading to informed decision-making, strategic planning, and faster time-to-market. These features provide a more efficient process for RA professionals, saving them time and offering more comprehensive search results compared to traditional methods.

NYQUISTAI PRODUCT HIGHLIGHT

In an era where the importance of Real-World Evidence (RWE) continues to grow across the product lifecycle from discovery to product approvals and post-market monitoring, NyquistAI stands at the forefront of this revolution. We’re leveraging the power of AI to synthesize RWE through systematic literature review, helping organizations reduce the time and cost of conducting this essential research.

Our Nyquist Scholar product is an AI-enabled medical writing tool that accelerates the time-consuming and bottleneck tasks of search, screening, full text review, and data mapping. But it’s more than just a tool—it’s a solution to the growing need for RWE in the healthcare industry.

Here are some ways Nyquist Scholar can help synthesize RWE:

• Recommendations: It’s the first AI-enabled medical writing screening tool that quickly reviews and recommends which papers should be included or excluded based on your criteria.
• “Chat” with Papers: Nyquist Scholar changes the game by delivering faster reports, reducing the gap between study selection and publication. Inquire about endpoints or patient population, or simply ask Nyquist Scholar to provide a summary.
• Data Aggregation: Nyquist Scholar can aggregate data from a variety of sources to get a comprehensive view while automatically deduping duplicate references.
• Evidence Generation: Nyquist Scholar can generate comprehensive analysis by analyzing real-world evidence. This evidence can support product approvals and post-market monitoring, aligning with the FDA’s push for more RWE.

Schedule a meeting with our team to learn more about how NyquistAI and the Nyquist Scholar can help you leverage Real-World Evidence for your organization’s success.

THIS MONTH IN AI, MEDTECH, & BIOPHARMA

Navigating FDA Approval for AI-Enabled Medical Devices

In the ever-evolving landscape of AI-enabled medical devices, navigating FDA approval is a pivotal journey for life science professionals. A recent article from MedTech Intelligence delved into this realm, shedding light on the complexities and strategies involved. Here’s a concise summary of the key insights:

1. Understanding FDA Regulations: Compliance with FDA regulations is crucial for ensuring the safety and efficacy of AI-enabled medical devices. This entails adherence to Predetermined Change Control Plans (PCCPs), guidelines for Software as a Medical Device (SaMD), and cybersecurity protocols.
2. International Harmonization: Streamlining regulatory processes globally is a priority. The FDA is actively collaborating with international bodies to align regulations, facilitating easier market access for manufacturers. FDA's
3. Commitment to Health Equity: Initiatives promoting diversity in clinical trials and ensuring accessibility to all patients underscore the FDA’s dedication to advancing health equity.
4. Best Practices for Approval: Engaging early with the FDA, developing robust PCCPs, and prioritizing cybersecurity are essential strategies for a successful approval process.

Further insights reveal:

• The FDA AI-enabled medical devices are primarily in radiology, often through the 510(k) clearance pathway.
• Efforts are underway to address challenges specific to AI/ML in medical devices, including minimizing bias and enhancing algorithm training.
• The FDA’s AI Program focuses on critical areas such as data augmentation, algorithmic bias, and continual learning, highlighting its commitment to driving innovation in this domain.

By tackling these regulatory hurdles head-on, manufacturers can navigate the FDA approval process with confidence, accelerating the delivery of transformative AI-enabled medical devices to patients worldwide. This progress reflects the FDA's unwavering dedication to promoting health equity and fostering the development of safe and effective medical innovations.

Click HERE to read the full article.

FDA List of Approved AI/ML Devices

Earlier this month, the FDA released an updated list featuring 191 new AI-enabled medical devices, signaling a promising trajectory for innovation in patient care. Radiology alone makes up 76% of this list, highlighting its critical role in enhancing diagnostic accuracy and efficiency. Industry leaders like Siemens Medical Solutions, GE, Philips, and innovative startups like Viz.ai and Lunit are at the forefront of this technological revolution.

Coverage Challenges

Despite FDA approval, insurance coverage remains limited. Currently, CMS reimburses only about 10 AI devices, highlighting a significant gap between regulatory approval and clinical integration.

Advocacy for Policy Reform

On May 13, 2024, patient advocacy groups appealed to Congress for CMS reimbursement of AI devices, aiming to include payment mechanisms in the 2025 Hospital Outpatient Prospective Payment Systems rule. This effort is crucial for ensuring patients benefit from these advanced technologies.?

Read more in our latest blog article

NyquistAI List of AI/ML Devices

Since the last FDA addition at the end of March, there have been 20 new devices approved that we have in our MedTech Data Platform:

• Radiology: 13
• Cardiovascular: 2
• Ophthalmic: 2
• Gastroenterology & Urology: 2
• Neurology: 1

At NyquistAI, we’re proud to that not only do we have the most up-to-date list of approved AI/ML devices, but we also boast the most comprehensive global coverage. Our listings include approvals from the FDA, China NMPA, EUDAMED, Health Canada, and Australia’s TGA.

Ready to supercharge your efficiency and free up time for strategy? Discover the benefits of our data intelligence platform today!

Schedule An Intro!