Nevro Corp. has submitted a premarket approval supplement to the U.S. FDA seeking a green light for its Senza system to treat chronic pain associated with painful diabetic neuropathy (PDN). This submission is expected to allow the company to gain approval and kick off U.S. launch activities for this indication in the second half of next year. Nevro would be tapping into a big market, as diabetes affects roughly 1 in 10 adults in the U.S. and can damage peripheral nerves, resulting in severe pain and numbness in the extremities.

U.S. federal government enforcement of the Foreign Corrupt Practices Act (FCPA) might not draw the attention that other matters draw, but the Securities and Exchange Commission (SEC) has made extensive use of the FCPA in 2020. SEC actions related to the FCPA may have accounted for only about 2% of the agency’s actions over the past year, but nonetheless accounted for nearly 80% of the penalties collected by the agency, and health care was second only to the oil and gas industries as the targets of FCPA action by the agency.

Rapid Medical Ltd.'s journey took a promising turn with a U.S. FDA clearance of Drivewire, the company's steerable guidewire for neuro and peripheral vasculature. Drivewire allows surgeons to adjust the shape of the tip while traversing challenging vasculature. It is the first neurovascular guidewire with a controllable distal end that permits on-demand course and shape changes during a procedure.

Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.

The U.S. FDA has exercised a considerable degree of enforcement discretion during the COVID-19 pandemic, particularly when it comes to digital health. However, Christine Bump, principal at Penn Avenue Law & Policy, said that this very discretion has an uncertain shelf life and advised industry to remain compliant with the regulations as much as possible to avoid unnecessary enforcement actions by federal agencies.

Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second quarter of 2021. The artificial heart offers a bridge to transplant in patients with end-stage biventricular heart failure. It provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated.