On Jan. 7, 2025, the FDA issued its draft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” In its latest draft guidance on medical devices, the FDA provides recommendations on the documentation and information that should be included in marketing submissions for devices that include AI-enabled device software functions.
Patents buttress and backstop growth for medical technology (medtech) companies, period. This is especially so for early-stage ventures staking their claim in the medtech ecosystem. A strategic patent portfolio is an essential building block to have in place for a medtech company’s growth and success, especially when it comes to generating revenue or fundraising. And
The medtech industry is positioned for continued growth as the aging world population faces many unmet medical needs. According to market analysts, industry revenue is predicted to grow to nearly $600 billion in 2024, with the cardiovascular, orthopedic, neurological, urological, and diabetes sectors driving that growth.
Several trends are shaping the medtech industry, presenting
This 5 Trends piece covers specialized offerings, autonomous vehicle companies, the drone industry, robotic-assisted surgeries, and intellectual property in robotics industry.
Continue Reading 5 Trends to Watch: 2024 Robotics
David J. Dykeman, co-managing shareholder of global law firm Greenberg Traurig, LLP’s Boston office and co-chair of the firm’s global Life Sciences & Medical Technology Group, was featured on the Product Success Podcast: Quality and Medical Devices on Sept. 16 hosted by Chuck Serrin, vice president industry marketing, medical-tech and life sciences, and
Advancements in artificial intelligence (AI) technology are impacting mental health and wellness with tools that are right at the user’s fingertips. Innovators are developing new ways to bring these technologies directly to the user, and investors and strategic partners are paying attention. According to Crunchbase, in 2020 there was a 112% increase in total investments
David J. Dykeman and Bethany A. Stokes co-authored a Medical Design & Outsourcing article titled “5 Keys to Stronger Medtech Agreements.”
Read the full article, “5 Keys to Stronger Medtech Agreements.”
The search for a vaccine for the COVID-19 strain of coronavirus has put the spotlight once again on the innovative pharmaceuticals sector. As pharmaceutical companies and innovators across the globe work diligently on a vaccine, many of these companies may be looking to protect their innovation. While patents have many benefits, in the face of a global health emergency, there are some key factors innovators should consider.
Timeline for Patent Registration
Patents can provide broad protection for invention and innovation. They can also create a significant advantage in the marketplace. However, patent registration takes time and may require significant resources. According to the United States Patent and Trademark Office (USPTO), on average, it takes approximately 22 months to get patent approval. This period may be shortened by taking advantage of one of the USPTO’s accelerated examination procedures and may be shortened by utilizing the USPTO prioritized examination option, where a final decision on patentability is made within 12 months from the filing date of the patent application.
Continue Reading The Race for a COVID-19 Vaccine is On: Key Factors May Impact Patent Protection