FDA

On Jan. 7, 2025, the FDA issued its draft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” In its latest draft guidance on medical devices

Continue Reading FDA Releases Draft Guidance on AI-Enabled Medical Devices

Emerging medical device companies should consider these points when weighing a potential merger, strategic partnership or investment:medical technology

1. Identify unmet medical needs

Medical device titans are actively looking to acquire new technologies to treat unmet medical needs and drive market adoption. Larger medtech companies often view early-stage companies as outsourced R&D labs, and will pay a premium price for products that can drive future revenue. The larger the potential market, the higher the value to medtech titans.

2. Know the market and competitors

Acquiring technologies that can transform or dominate a market drives many deals and collaborations. Disruptive technologies that improve patient outcomes are in high demand. Larger medtech companies are always on the lookout for new devices or improved treatments that have no or few competitors. Understanding the strategic investment goals and criteria of potential suitors will further refine and focus a growing medtech company’s efforts to gain visibility and generate productive relationships.
Continue Reading M&A, Investment or Partnering Checklist for Medtech Companies