The U.S.FDA said the recall of two models of the Pipeline Flex embolization devices is due to a risk that the delivery system’s wire and tubes will fracture during placement of the stent. The agency said the recall is associated with 59 reports of malfunction, 10 serious injuries and two fatalities, making this a class I event.

Roughly a decade has passed since the FDA first approved a transcatheter aortic valve replacement (TAVR) device, but the U.S. market has proven difficult to access for more than a small number of manufacturers. Abbott Laboratories, of Abbott Park, Ill., is now a player in the market with the FDA’s approval of the Portico device, a product that was first implanted in a human subject in 2011, a clear demonstration of the difficulty of moving these devices from research and development to the market.

Physicians occasionally go over the line where Medicare services are concerned, but the U.S. Department of Justice announced Sept. 15 that a cardiologist in Orlando, Fla., went farther than the ordinary illicit billing.

The FDA reported the elevation of its information technology (IT) office to an agency-level office, a move that gives the agency a heightened priority for eliminating some of the balkanization of computer systems.

Special purpose acquisition companies (SPACs) have been making headlines recently in the life sciences, but these entities practice a business model that leaves some observers uneasy. Gary Gensler, chairman of the U.S. Securities and Exchange Commission (SEC), told a Senate committee recently that the risks to investors in SPACs has prompted him to ask his staff to come up with some proposals to increase transparency to investors, potentially leading to additional compliance costs for these entities.

The U.S. Federal Trade Commission (FTC) has taken a more assertive stance regarding enforcement of several considerations, most conspicuously about mergers and acquisitions. However, the agency’s push for less cumbersome processes has now been applied to a host of considerations pertinent to the life sciences, including bias found in artificial intelligence algorithms, abuse of drug patents, and repairs for medical equipment, a signal that more frequent and more rapid FTC enforcement is on the near horizon.

The new regulatory framework for the EU is now in force, and it touches on the respective roles of manufacturers, distributors and other economic operators (EOs). Erik Vollebregt, of Axon Lawyers in Amsterdam, told an audience at the 2021 Regulatory Convergence sessions that the roles and responsibilities of these EOs are frequently misunderstood, a predicament that amplifies the regulatory and legal risk for all these entities doing business in the EU.

The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the rule for the Medicare Coverage of Innovative Technologies (MCIT) program, an action that predates the agency’s self-imposed deadline of December 2021 by three months. The agency cited some previously discussed issues with the rule, but the move was blasted by industry as thwarting the support of the majority of stakeholders.

The med-tech market in China has lured many device makers and investors into doing business there despite concerns about intellectual property (IP) theft. While some of those IP theft worries have eased, China’s National Medical Products Administration (NMPA) is still implementing an order that came into force June 1, creating an environment of massive regulatory uncertainty that will force device makers to navigate carefully when attempting to access the world’s largest med-tech market.

There are few guidelines of any sort that are specific to artificial intelligence (AI) for medical devices, but that doesn’t mean there are no signposts for developers. There are existing product marketing authorizations that offer some insights, but the FDA’s Bakul Patel said a risk stratification guidance by the International Medical Device Regulators Forum (IMDF) is an example of a non-AI blueprint for how the FDA will ultimately approach regulation of AI.