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FDA Awards Breakthrough Designations to Two Medical Device Firms; 92% of Companies Forced to Rewrite Contracts Amid Trade Chaos, Report Finds; Vertical Bridge Completes $595M Securitization

16.9.25

WASHINGTON – A pair of innovative medical device companies, ClearCam and PatenSee, have each received prestigious Breakthrough Designations from the U.S. Food and Drug Administration (FDA) for their respective technologies. This news on medical innovation comes as a new report from Agiloft reveals the profound impact of global trade volatility, with 92% of organizations having been forced to rewrite contracts. In the world of finance, a major transaction was completed as communications infrastructure giant Vertical Bridge closed a nearly $600 million asset-backed securitization.

Medical Device Innovators Earn FDA Breakthrough Designations

In a significant step forward for patient care, two medical technology companies were recognized by the FDA. ClearCam, Inc., an Austin-based company, was awarded a national group purchasing agreement for Breakthrough Technology with Premier, Inc. for its surgical solutions.

Separately, PatenSee, an Israeli-American company, received an FDA Breakthrough Device Designation for its non-contact, AI-driven platform designed to manage vascular access for patients undergoing hemodialysis. The Breakthrough Device program is intended to provide patients and healthcare providers with timely access to innovative medical devices by expediting their development, assessment, and review.

Global Trade Chaos Rewrites Corporate Strategy

A new report from contract lifecycle management (CLM) provider Agiloft has exposed the deep impact of global trade instability on businesses. The survey of over 600 legal professionals found that a staggering 92% of organizations have been forced to rewrite contracts in response to supply chain disruptions, geopolitical events, and market volatility. The report warns of lasting impacts on cost, compliance, and supplier relationships as companies scramble to adapt their corporate strategies to a chaotic global trade environment.

In a related story highlighting digital disruption, research from SpeedyIndex revealed a growing "indexing crisis," with an estimated 40% of new web content remaining invisible to Google within its first month of publication, impacting marketing and visibility for businesses.

Major Financial Deals in Infrastructure and Private Credit

Vertical Bridge REIT, LLC, the largest private owner and operator of communications infrastructure in the U.S., announced it has completed a $595.1 million asset-backed securitization. The transaction underscores strong investor confidence in the digital infrastructure sector.

In another major financial development, European private credit manager LCM Partners announced the €3.8 billion first close of its Credit Opportunities 5 strategy, showcasing significant fundraising success in the private credit market.

In Brief: Technology, M&A, and Community Support

  • Technology: BrainCo, a brain-computer interface company, unveiled its next-generation bionic dexterous hand, the Revo2 Hand for humanoid robotics. In another tech story, CloudX announced it has become the first company to have a 100% AI-certified workforce, with all 300+ of its global employees now certified in artificial intelligence.

  • Corporate M&A: Mobile Communications America (MCA), a national leader in integrated communications solutions, announced its acquisition of Beck Tech, deepening its commitment to customers in the Midwest.

  • Community & Philanthropy: Boston Mutual Life Insurance Company was named among the most charitable companies in Massachusetts by the Boston Business Journal for the seventh consecutive year. Law firm Richards Family Law also announced its sponsorship of the Furniture Bank of Metro Detroit's annual "Furniture Flip Bash."

  • Legal Trend: The day saw a continued flood of announcements from law firms, particularly Levi & Korsinsky, LLP, notifying investors of class action lawsuits and lead plaintiff deadlines for numerous public companies, including Tesla, Inc. (TSLA), Lockheed Martin Corporation (LMT), and Snap Inc. (SNAP).


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