How the FTC Is Shaping Medical Device M&A in 2025-2026

Antitrust Enforcement Is Rewriting the Medtech M&A Playbook

For decades, medical device M&A operated in a relatively predictable regulatory environment. Large acquirers could absorb smaller innovators with minimal antitrust friction, especially for devices still in clinical development. That era is over.

In 2025 and early 2026, the Federal Trade Commission (FTC) has brought two landmark merger challenges targeting the medical device industry — the only two litigated merger cases in the period — producing divergent outcomes that are fundamentally reshaping how medtech deals are structured, negotiated, and defended. Both cases involved medical devices critical to patient care: transcatheter heart valves and coatings for catheters and guidewires.

At the same time, the HSR filing process has undergone its most significant overhaul in 45 years, and states are rapidly enacting their own "mini-HSR" laws, creating a new multi-layered merger review regime that every medtech dealmaker must navigate.

Edwards/JenaValve: The FTC's Landmark Win

The most consequential antitrust action in medtech in 2025-2026 was the FTC's successful challenge of Edwards Lifesciences' proposed ~$945 million acquisition of JenaValve Technology.

The Deal and the Concerns

Edwards Lifesciences, a dominant player in structural heart devices, sought to acquire JenaValve, a developer of transcatheter aortic valve replacement (TAVR) devices specifically designed to treat aortic regurgitation (AR). AR is a severe heart condition affecting millions of Americans over 50 that can lead to heart failure if untreated, and no TAVR-AR device had yet received FDA approval at the time of the challenge.

What made this case extraordinary was that Edwards had already quietly acquired JC Medical — another TAVR-AR developer — in a separate deal that fell below the HSR reporting threshold. Combined, the two acquisitions would have given Edwards control over the only two companies conducting U.S. clinical trials for TAVR-AR devices.

In August 2025, the FTC voted unanimously (3-0) to challenge the acquisition, alleging it would:

• Eliminate head-to-head competition between the only two U.S. clinical-stage TAVR-AR programs
• Reduce incentives for innovation, giving Edwards reason to delay or discontinue one device
• Potentially increase prices for patients who would have no alternative suppliers

Daniel Guarnera, Director of the FTC's Bureau of Competition, stated: "Edwards' attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves."

The Court's Ruling

On January 9, 2026, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted the FTC's petition for a preliminary injunction, blocking the deal. Edwards abandoned the acquisition the following day.

The court's ruling broke new ground in several critical ways:

1. Pre-commercial innovation markets are enforceable. The court accepted that even though no TAVR-AR device was FDA-approved for commercial sale, there was "indisputably ongoing competition" between Edwards and JenaValve in the research, development, and anticipated commercialization of these devices.

2. Pipeline products can define a relevant market. Building on the Fifth Circuit's Illumina v. FTC precedent, the court held that products in clinical trials could constitute a valid antitrust market because there is "ongoing competition to bring additional products to market."

3. Deal structuring cannot evade scrutiny. The court pointed to testimony suggesting Edwards' acquisition of JC Medical was deliberately priced below the HSR reporting threshold and timed so the larger JenaValve deal would close first — a sequencing strategy the court viewed as relevant to assessing competitive effects.

4. Divestiture was available but rejected. The FTC offered Edwards the option to divest JC Medical to resolve concerns, but Edwards "repeatedly rejected" this remedy.

The Aftermath: Competition Vindicated

In a striking validation of the FTC's rationale, JenaValve's Trilogy transcatheter heart valve received FDA PMA approval in March 2026 for aortic regurgitation — making it the first TAVR-AR device approved for commercial sale in the United States. Had the Edwards acquisition closed, this independent competitive milestone might never have occurred.

Implications for Future Deals

The Edwards/JenaValve precedent sends a clear signal: the FTC can and will challenge acquisitions of pre-commercial, development-stage companies when competition in innovation is at stake. Medtech companies planning to acquire clinical-stage startups — particularly in markets with few competitors — must now factor in the risk that these deals will face serious antitrust scrutiny, even when neither party has a commercially available product.

GTCR/Surmodics: The FTC's First Loss Under Trump 2.0

While the FTC scored a decisive win in Edwards/JenaValve, it suffered its first merger challenge loss of the second Trump administration in the GTCR/Surmodics case — a result that offers equally important lessons for medtech dealmakers.

The Deal

In 2022, private equity firm GTCR acquired a majority stake in Biocoat, the second-largest U.S. provider of outsourced hydrophilic coatings — critical coatings used to reduce friction on medical devices such as catheters, guidewires, and stents. In 2024, GTCR proposed to acquire Surmodics, the largest provider, for $627 million. The FTC alleged the combined company would control over 50% of the outsourced hydrophilic coatings market, with a combined share the FTC's economic expert calculated at 60%.

The Challenge

The FTC filed its challenge in March 2025, joined by the states of Illinois and Minnesota. Notably, the complaint dropped any reference to GTCR's private equity status as a concern — a departure from Biden-era rhetoric about PE roll-ups — and instead focused on traditional horizontal merger theory.

The Fix That Worked

In the summer of 2025, GTCR negotiated a divestiture of certain Biocoat assets to Integer Holdings, a large medical device contract manufacturer. The divestiture package included 10 coating products, 11 employees, a former production facility, and a portion of customer contracts.

The FTC rejected the proposed divestiture on August 13, 2025, calling it a "piecemeal" set of assets insufficient to preserve competition. But on November 10, 2025, Judge Jeffrey Cummings of the Northern District of Illinois denied the FTC's request for a preliminary injunction, finding that:

• The divestiture was sufficient to resolve competitive concerns
• Integer was an "exceptionally well qualified divestiture buyer" that would "vigorously attempt to compete"
• The FTC's market definition was too narrow because it excluded OEMs with in-house coating capabilities that provided a competitive constraint
• The FTC's reliance on past revenue data was unreliable given the realities of medical device development and approval cycles

The FTC announced on November 14 that it would not appeal, and GTCR promptly closed the transaction.

Takeaway: "Litigating the Fix" Works

The GTCR/Surmodics case established that parties can successfully "litigate the fix" — that is, develop a divestiture remedy during litigation and present it to the court, even over the government's objection. This approach is now a viable strategy for medtech acquirers facing FTC challenges, provided the divestiture buyer is credible and the remedy addresses the competitive overlap.

The HSR Filing Overhaul: New Rules, New Burdens

Beyond individual merger challenges, the FTC has reshaped the entire pre-merger notification landscape.

The Biggest HSR Form Update in 45 Years

In February 2025, the most substantial overhaul of the HSR filing form in its history took effect. The updated form requires:

• Broader document submissions — more transaction descriptions, business documents, and strategic plans
• Foreign subsidy disclosure — parties must disclose subsidies received from "foreign entities or governments of concern" (currently defined as China, Iran, North Korea, and Russia) within two years of filing
• Defense contract disclosure — active government defense contracts must be reported
• English translations — all foreign-language documents must be translated, adding significant cost for cross-border deals

These changes apply universally but have been particularly burdensome for healthcare and medical device transactions given the global nature of medtech supply chains.

Court Vacates the New Rules — Then a Stay

On February 12, 2026, a federal court in Texas vacated the expanded HSR form, ruling the FTC had overstepped. On March 19, 2026, the Fifth Circuit denied the FTC's motion for a stay pending appeal, meaning the pre-February 2025 (legacy) HSR form is currently back in effect. However, the FTC and DOJ launched a joint public inquiry on March 25, 2026, seeking comment on whether to pursue new rulemaking regardless of the litigation outcome. Comments are due May 26, 2026.

For medtech dealmakers, this creates uncertainty: the filing requirements may shift again depending on how the appeal resolves.

2026 Threshold Increases

The FTC's annual threshold adjustments for 2026, effective February 17, 2026, include:

Most medtech mega-deals (like Abbott/Exact Sciences at $21B or Boston Scientific/Penumbra at $14.5B) far exceed these thresholds, but the reporting floor matters for mid-market and bolt-on acquisitions that make up the majority of deal volume.

Early Termination Returns

Under the Trump administration, the FTC resumed the practice of granting early termination of the HSR waiting period — a welcome change for dealmakers after a years-long moratorium. FTC leadership has also expressed intent to "get out of the way" of transactions that do not violate antitrust law, signaling a more permissive stance for clearly pro-competitive deals.

State-Level "Mini-HSR" Laws: A New Layer of Scrutiny

Perhaps the most underappreciated development in medtech M&A regulation is the rapid spread of state-level pre-merger notification requirements.

The Current Landscape

Three states have now enacted broad "mini-HSR" laws based on the Uniform Antitrust Pre-Merger Notification Act (UAPNA):

Under these laws, any party filing an HSR-reportable transaction must also submit a copy of their HSR filing to the state attorney general if the party has its principal place of business in that state or derives revenue in the state of at least 20% of the HSR filing threshold (approximately $26.8 million in 2026).

Healthcare-Specific State Laws

Beyond the general mini-HSR regime, California also enacted Assembly Bill 1415 in October 2025, which specifically targets healthcare transactions involving private equity firms and management services organizations (MSOs). As of January 1, 2026, these entities must seek approval from California's Office of Health Care Affordability (OHCA) for certain transactions. Rhode Island has enacted similar healthcare-specific transaction reporting requirements.

What This Means for Medtech

For medical device companies — most of which do business in all 50 states — state mini-HSR laws mean:

• More filing obligations with more attorneys general, increasing compliance costs
• Parallel review timelines with state and federal authorities
• Risk of state-level challenges even when federal agencies clear a deal
• More states are expected to follow — multiple additional states and the District of Columbia have similar legislation pending

The Broader Regulatory Environment Under Trump 2.0

The Trump administration's approach to medtech antitrust has been characterized by continuity in some areas and departure in others.

Continuity: Healthcare Remains a Priority

Both the GTCR/Surmodics and Edwards/JenaValve cases were brought under the second Trump administration, confirming that healthcare M&A enforcement remains a bipartisan priority. The FTC's two litigated merger challenges in 2025 were both in medical devices, and antitrust commentators expect this focus to continue.

Departure: Pro-Business Process Changes

The administration has introduced several process-friendly changes:

• Early termination of HSR waiting periods has resumed after years on pause
• The 2023 Merger Guidelines were not rescinded as some expected, but the FTC's posture is generally viewed as more receptive to remedies and divestitures
• Pro-divestiture vs. blocking — the GTCR/Surmodics outcome suggests courts are receptive to merger fixes, but the Edwards/JenaValve result shows the FTC will still pursue outright blocks when warranted

Notable Additional Medtech-Adjacent Enforcement

The Owens & Minor/Rotech deal — combining two companies that deliver medical supplies and equipment to homes — was terminated in 2025 after the parties concluded that the "path to obtain regulatory clearance proved unviable." The Boeing/Spirit AeroSystems merger required the FTC to mandate divestiture of several Spirit assets before approval in December 2025.

What Medtech Dealmakers Should Do Now

Based on the 2025-2026 enforcement landscape, medical device companies planning acquisitions should:

1. Conduct pre-commercial competition analysis. If your target is a clinical-stage company and you (or your subsidiaries) have a pipeline product in the same therapeutic area, expect the FTC to scrutinize the deal under an innovation competition theory.

2. Avoid HSR threshold gaming. The Edwards/JenaValve decision explicitly flagged deal structuring designed to stay below HSR thresholds as relevant to competitive effects analysis. Sequential acquisitions of competing targets will draw heightened scrutiny.

3. Prepare a credible divestiture remedy early. The GTCR/Surmodics case shows that developing a divestiture package during litigation — with a qualified buyer — can defeat an FTC challenge. But the divestiture must be comprehensive, not "piecemeal."

4. Budget for state-level compliance. With Washington, Colorado, and California now requiring HSR filings to be shared with state AGs — and more states likely to follow — medtech companies need to build state-level antitrust compliance into their deal timelines and budgets.

5. Monitor the HSR form litigation. The legacy HSR form is currently in effect after the Texas court vacated the expanded version, but this could change on appeal. The FTC may also pursue new rulemaking. Stay current on filing requirements through counsel.

6. Engage the FTC early on remedies. While the Edwards case showed the FTC will reject remedies it considers insufficient, early engagement on divestitures — before litigation — remains the lowest-risk path to closing.

Looking Ahead: FTC Medtech Enforcement in 2026 and Beyond

The FTC has signaled that medical devices will remain an enforcement focus area. With record deal volumes in medtech — over $80 billion in announced deals in 2025 alone — and several mega-deals pending (Abbott/Exact Sciences, Boston Scientific/Penumbra, BD/Waters), the FTC's medtech docket is likely to remain active.

Key areas to watch:

• Cardiovascular device consolidation — With Stryker/Inari ($4.9B), Boston Scientific/Penumbra ($14.5B), and Medtronic's cardiovascular portfolio expansion, the FTC may scrutinize further consolidation in thrombectomy, PFA, and structural heart
• PE roll-ups in healthcare supply chains — Despite the GTCR loss, the FTC's focus on serial acquirers in healthcare inputs (coatings, contract manufacturing, diagnostics) is unlikely to fade
• AI/digital health acquisitions — As medtech incumbents acquire AI-enabled diagnostic companies (e.g., Medtronic/CathWorks at $585M), the FTC may apply innovation competition theories to AI-driven product markets
• State AG coordination — The new mini-HSR laws create the infrastructure for state attorneys general to collaborate with federal enforcers and bring their own challenges

For medtech companies, the message is clear: antitrust analysis is no longer a late-stage checkbox in the deal process. It must be embedded in strategic planning from the earliest stages of target identification and deal structuring.