Negotiations between the FDA and industry over the next device user fee are going on behind closed doors, but the agency’s summaries of these meetings suggest there are sharp disagreements. While the FDA continues to press industry on additional fees for the total product life cycle advisory program, industry’s dissatisfaction with the FDA’s fiscal management of the user fee program has prompted a demand for a one-off audit of the agency’s use of those user fees.

Medicare coverage of telehealth services in the U.S. received a boost during the COVID-19 pandemic, a change that stakeholders have argued should be made permanent. The Centers for Medicare & Medicaid Services (CMS) has proposed to extend coverage of some of these services throughout calendar year 2023 in the draft Medicare physician fee schedule, but some stakeholders are urging Congress to act before the end of the year to make these benefits permanent.

10x Genomics Inc. launched its latest platform for single-cell analysis, the Chromium X Series, to cost-effectively "enable massively large-scale experiments," according to the company. The system cuts the cost of single-cell analysis 83%, from 12 cents to 2 cents per cell, a significant step toward reducing the costs low enough to make genomic sequencing widely available.

Hoping to get Germany to drop its opposition to a proposed World Trade Organization (WTO) waiver of intellectual property (IP) rights, several U.S. lawmakers have asked to meet with German Chancellor Angela Merkel when she’s in Washington for a July 15 summit with President Joe Biden.

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.