With the next user fee agreement negotiations underway, device makers are not keen on a substantial hike in fee volumes. Nonetheless, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, has proposed a total product life cycle (TPLC) advisory function for the next user fee agreement, something he said would bring more predictability to industry and allow the agency to interact much more routinely with device makers.

The FDA’s breakthrough devices program encodes a number of policy objectives for the agency, but industry might see the program principally as a vector for faster time to market. However, Janice Hogan, partner at Hogan Lovells US LLP, said device makers might want to consider that the greater benefit is reducing regulatory uncertainty, not beating the typical FDA review clock.

The FDA’s legal authority to regulate lab-developed tests (LDTs) has come into question on several occasions in a number of venues, and the issue is enjoying new life yet again thanks to more activity on Capitol Hill. While two competing pieces of legislation are back in play, the most critical question may be whether the FDA has any authority left at all after the August 2020 rescission letter from the Department of Health and Human Services.

The latest report by the Medicare Payment Advisory Commission (MedPAC) includes an advisory about unfettered expansion of telehealth, but the commission also said that expanded access to ambulatory surgical centers could trim per-procedure spending, which in some instances is about half the fee paid for a given procedure when performed in a hospital outpatient department (HOPD).

In the last decade, responsive neurostimulation (RNS) has become a mainstay of treatment for refractory focal epilepsy, but challenges with the technology remain. Researchers at Columbia University in New York appear to have overcome some of the major limitations through development of a compact, flexible, high performance implantable device that permits reading and manipulation of brain circuits.

Egnite Inc. emerged from stealth mode in February 2021 with the goal of combining data analytics and digital health technology to illuminate and solve persistent issues in the diagnosis and treatment of structural heart disease. Three months later, it has added artificial intelligence (AI) to its flagship solution, Cardiocare, to drive better diagnosis of aortic stenosis and help physicians predict patient outcomes.

The controversy over the use of ethylene oxide (EtO) is back in play, thanks to a May 5 letter from the Office of Inspector General at the Environmental Protection Agency to the EPA. The letter recommends that the agency revisit its work on determining the status of EtO based on new data, data that may lead to more restricted use of EtO to sterilize medical devices.

A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S.

Almost 11 years to the day after first gaining FDA clearance, the Sonarmed airway monitoring system finally launched on a commercial scale in the U.S. The new rollout appears likely to revive the product’s prospects as it comes with significantly increased financial backing and deep connections to hospitals as a result of Sonarmed’s acquisition by Medtronic plc in December 2020. The system, which uses acoustic technology to identify endotracheal tube obstruction and verify proper tube positioning in neonates and infants who require invasive mechanical ventilation, has been implemented in a small number of hospitals to date.