The COVID-19 pandemic may have been largely responsible for the lower volume of enforcement activities against device makers in 2020, but the volume of these activities seems to be ramping up in 2021. Recently, the FDA posted a large batch of warning letters to device makers while the U.S. Department of Justice (DoJ) announced two new enforcement actions, including a $27 million fine to the operators of durable medical equipment distributorships for kickbacks, part of a growing set of signals that enforcement is back in vogue in the U.S.

The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said.

Axogen Corp. has developed a suite of products to meet the needs of the 1 million patients in the U.S. who undergo surgery each year to repair peripheral nerve damage. While the process the company uses to decellularize nerves harvested from human donors and clear them of all cellular debris so they can be used as scaffolding for nerve regeneration has been successful, with the Recon study, Axogen aims to increase the utility of the purified nerve tissue by adding materials that promote growth.

The FDA’s draft guidance for the form and content of unique device identifiers (UDIs) may have lacked the controversy of some other policies, but the 2016 draft languished for five years even though only 10 comments appear in the docket. While the agency made some concessions regarding substantial edits of the draft, the final retains a need for data delimiters in the definition of “easily readable” plain text in UDIs, despite industry’s argument that this was not required in the agency’s UDI rulemaking.

The FDA granted breakthrough device designation for the Hyalex Cartilage System, a biomimetic materials platform designed to restore function and repair cartilage defects in the knee. The system, developed by Hyalex Orthopaedics Inc., combines two polymers that improve adhesion on one side and create a low-friction surface that protects the cartilage counterface on the other.

A large health system in Minnesota recently became the first in the world to have completed a structural heart procedure, or any other surgical procedure for that matter, using any kind of 4D hologram technology. The technology was developed by venture capital-backed startup Echopixel Inc., and it is intended to improve both surgical precision and outcomes in minimally invasive procedures.

The U.S. Securities and Exchange Commission (SEC) has had Parallax Health Sciences Inc. in its crosshairs at least as far back as April 2020, when the agency suspended trading of the company’s shares. In the latest development, the SEC charged the company and two of its executives with misleading investors regarding the availability of COVID-19 screening tests and personal protective equipment, actions the agency said were undertaken to exploit the pandemic in an effort to boost the company’s share prices.

Hyerfine Inc. and Liminal Sciences Inc. have joined a growing field of med-tech startups that are combining with blank check companies as an alternative path for venture-backed companies to an initial public offering (IPO). On Thursday, the companies announced a three-way combination with Healthcor Catalio Acquisition Corp., a special purpose acquisition company (SPAC), in a deal valued at approximately $580 million.