Patent attorneys Kirsten Johnson and Les Bookoff detail the patent term extension process, which, they say, is a crucial tool for device companies to maximize return on investments for innovative new technologies.
Clearing government regulations to commercialize a medical device can be an arduous and lengthy process. When clinical trials are involved, companies can spend as long as 5 to10 years to gain approval from FDA and invest $100 million or more to bring a device to market. Patents are key to recouping these costs by preventing others from copying successful products.
Yet, until device companies gain approval to market the device, their patent rights are far less useful. By the time...
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.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
