Legal & IP
A California jury found in favor of device firm Masimo in a long-running legal battle against the tech giant. Apple has already announced plans to appeal.
Ceribell has filed patent-infringement claims against Natus alleging its BrainWatch EEG copies Ceribell’s headband and electrode innovations. Natus denies any intellectual property violations, saying the products serve different purposes.
Insurance firm UnitedHealth is facing allegations the company intentionally used an unreliable PAD screening method to increase its reimbursements under Medicare Advantage. Semler Scientific and Bard, which respectively made and manufactured the products in question, settled related cases for $37m.
Emma Mittelstaedt Burnham prosecuted antitrust violations in healthcare sector in her previous work at DoJ, including leading investigation into antitrust cartels in the generic pharmaceutical industry.
Federal False Claims Act settlements hit $3.8bn in the first half of fiscal 2025, with enforcement expected to intensify, Barnes & Thornburg partner Jackie Papish tells Medtech Insight. Key watch areas include qui tam cases, DEI policy implications, and growing scrutiny of diagnostics.
The US International Trade Commission has banned smart rings from Ultrahuman and RingConn after Oura Health's patent infringement case. Ultrahuman countersued, claiming Oura infringes its intellectual property. Sales and marketing of the affected rings will cease on October 22.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.