The U.S. FDA final guidance for microneedling devices is a product-specific guidance, but it raises questions about the agency’s perspective on how a manufacturer’s intended use is inferred. Despite concerns voiced by industry, the microneedling devices final guidance retains a feature of the draft that allows the agency to infer intended use from the manufacturer’s “expressions,” a provision that raises yet again the long-standing commercial speech problem.

Abbott Laboratories has seen the launch of the IonicRF Generator, which delivers a nonsurgical, minimally invasive treatment for the management of pain in the nervous system. The generator is a radiofrequency (RF) ablation device that uses heat to target specific nerves and block pain signals from reaching the brain. The launch of Abbott's IonicRF Generator looks to help the estimated 50 million people in the U.S. currently living with chronic pain.

Preparing for a Biden presidency in which COVID-19 will be a top priority, the Joe Biden-Kamala Harris transition team named a board of scientists and public health experts Nov. 9 to advise the team on how to respond to the surging pandemic in the U.S.

The use of liquid biopsies, tests that look for variants in cell-free DNA (cfDNA) shed by tumors into blood plasma, could lead to misdiagnosis and inappropriate treatment in many cancers, according to University of Washington researchers. The tests misidentified a noncancer mutation that is particularly common in older people as a mutation used as a biomarker for PARP inhibitors indicated for use in prostate cancer, a study published in JAMA Oncology found, but the problem likely extends to other malignancies.

Zimmer Biomet Holdings Inc. fell in line with other orthopedic device companies that saw better than expected results for the 2020 third quarter. The company reported total revenue of $1.93 billion, up 1.1% from the same period in 2019.

The controversy over the U.S. FDA’s authority to regulate lab-developed tests (LDTs) took on a new set of considerations due to the COVID-19 pandemic. However, a June 22 memo by HHS General Counsel Robert Charrow pokes holes in the FDA’s argument on several fronts. Among these is the question of whether an LDT can be regulated by the FDA, given that a test is not usually offered for sale across state lines.

Becton, Dickinson and Co. (BD) reported good news Thursday, as it saw quarterly revenues of $4.784 billion for its fourth fiscal quarter, an increase of 4.4% over the prior-year period. Of note, the company’s life sciences segment saw worldwide revenues of $1.488 billion, representing an increase of 31.2% over the prior-year period as reported, or 31.4% on a currency-neutral basis.

Haemonetics Corp. reported sales of $209.5 million for the second quarter of fiscal year 2021, down 17.1% from the same period the prior year. Plasma sales declined 32.4% year over year to $78.4 million in the face of continuing COVID-19 impacts on blood donor activity. As Jeffries analyst Anthony Petrone observed, “Trough is rear view but plasma headwinds still elevated” through the period ended Sept. 26, “though declines were lower than expected (actual -30%; JEF -28% cc).”

As might be expected, device makers have a lot of nice things to say about a recent proposal by the U.S. Centers for Medicare & Medicaid Services (CMS) to automatically cover technologies designated as breakthrough devices by the FDA. However, two trade associations and the Medicare Payment Advisory Commission (MedPAC) all expressed serious misgivings about a proposal to define the term “reasonable and necessary” as possibly contingent on private payer coverage.