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HistoSonics

Developer of the Edison histotripsy system.

Contents11 sections
Key facts

Formation

HistoSonics was cofounded by University of Michigan engineers and physicians to commercialize histotripsy developed there. Its cofounders include Zhen Xu.⁠[1]

Technology and Management

Edison uses focused ultrasound to create bubbles that mechanically destroy targeted liver tumors. The company states that FDA has not evaluated cancer treatment outcomes, five-year survival, or overall survival.⁠[2]

The company website lists Mike Blue as president and chief executive officer.⁠[3]

FDA Decision

FDA granted Edison System’s De Novo request DEN220087 on this date, classifying it as a focused ultrasound system for nonthermal mechanical tissue ablation.⁠[4]

Majority Stake Transaction

Financing

Kidney Submission

The company announced a De Novo submission to FDA for kidney tumor destruction, explicitly describing that use as investigational at the time.⁠[7]

New Financing

The company announced financing involving Yosemite and others at a $3.75 billion valuation; the amount raised was not disclosed.⁠[8]

CE Mark

The company announced Edison’s CE mark and a phased European rollout.⁠[9]

Hong Kong Training Center

The company announced an expanded histotripsy training center at Gleneagles Hospital Hong Kong, increasing hands-on training and clinical observation capacity. The center was established in May 2025.⁠[10]

Related Organizations, Websites, and Public Accounts

Sources

  1. Tumor-destroying sound waves receive FDA approval for liver treatment in humans (opens in a new window)
  2. HistoSonics | Leader in Histotripsy (opens in a new window)
  3. About Us | HistoSonics (opens in a new window)
  4. Device Classification Under Section 513(f)(2) (De Novo) (opens in a new window)
  5. HistoSonics Announces $2.25B Acquisition by Consortium of Top-Tier Investors (opens in a new window)
  6. HistoSonics Announces Oversubscribed $250 Million Growth Financing (opens in a new window)
  7. HistoSonics Moves to Advance Additional Histotripsy Applications Announcing FDA Submission for Kidney Tumors (opens in a new window)
  8. HistoSonics Announces Financing with Participation from Yosemite Among Other Strategic Investors (opens in a new window)
  9. HistoSonics Receives CE Mark, Unlocking Access Across Europe and Accelerating Global Commercialization of the Edison® Histotripsy Platform (opens in a new window)
  10. HistoSonics Opens Expanded Histotripsy Training Center in Hong Kong (opens in a new window)
  11. HistoSonics, Inc. (@histosonics) / X (opens in a new window)
  12. HistoSonics, Inc. | LinkedIn (opens in a new window)