WASHINGTON, D.C. — Edwards Lifesciences Corp. and Genesis MedTech Group Limited agreed to pay a record $12 million to settle Federal Trade Commission allegations that they structured a medical-device acquisition to avoid mandatory antitrust review.
Edwards, including former Genesis subsidiary JC Medical, will pay $10 million, while Genesis will pay $2 million under a proposed final judgment filed in the U.S. District Court for the District of Columbia.
The combined penalty is the largest imposed for failure to submit a required Hart-Scott-Rodino Act filing, the FTC reported.
The settlement stems from Edwards’ July 2024 acquisition of JC Medical, a developer of transcatheter aortic valve replacement devices for aortic regurgitation. Federal regulators alleged the parties divided related payments to keep the transaction below the reporting threshold then in effect.
Edwards agreed to pay $115 million plus potential milestone payments for JC Medical, just under the $119.5 million threshold that triggered mandatory review at the time. The company also made a contemporaneous $25 million investment in Genesis connected to the acquisition, according to the FTC’s complaint.
Regulators contend the combined transactions exceeded the statutory threshold and should have been reported before closing. The Hart-Scott-Rodino Act requires qualifying transactions to be disclosed to federal antitrust agencies and subjected to a waiting period before completion.
“Companies that try to sneak deals through without lawful FTC review should take notice,” FTC Chairman Andrew Ferguson stated. “The FTC will be vigilant in enforcing the requirements of the Hart-Scott-Rodino Act.”
The JC Medical acquisition occurred one day before Edwards sought to acquire JenaValve Technology Inc., the only other U.S. company with a transcatheter aortic valve replacement device for aortic regurgitation in clinical trials.
The FTC later sued to block the JenaValve transaction, arguing that Edwards would control the only two companies developing such devices in the United States. A federal judge granted the commission’s request for a preliminary injunction in January 2026 following a six-day hearing.
Beyond the penalties, Edwards must provide the FTC with advance written notice before acquiring an ownership interest in certain companies developing or selling aortic-regurgitation valve replacement devices in the United States.
The requirement covers businesses commercially selling such devices, conducting U.S. clinical trials or holding a Food and Drug Administration investigational device exemption for those trials.
Edwards must also establish and maintain an antitrust compliance program.
The commission voted 2-0 to accept the settlement and refer it to the Justice Department, which filed the complaint and proposed judgment on the FTC’s behalf.
The agreement requires approval from the federal court. Entry of the final judgment would not constitute an admission or finding of wrongdoing, and the defendants deny violating the law.
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