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.

The NIH and CDC granted researchers at the Feinstein Institutes for Medical Research at Northwell Health $700,000 to investigate an in-the-ear stimulator as a treatment for post-traumatic stress disorder (PTSD) in first responders to the attack on the World Trade Center 20 years ago. The researchers will enroll 30 World Trade Center first responders with chronic PTSD in a sham-controlled trial to test the effectiveness of a device that uses transcutaneous auricular stimulation of the vagus nerve, which has shown promise in preclinical studies.

Driven by advances in scientific understanding, the treatment of non-small-cell lung cancer (NSCLC) has begun to see successes one subtype at a time. At the 2021 World Conference on Lung Cancer (WCLC), which is currently being held in virtual format, researchers were optimistic that the same path would be possible for small-cell lung cancer (SCLC).

The COVID-19 pandemic has exerted a significant effect on enforcement in the U.S., but Ethan Davis of King & Spalding (K&S) said federal prosecutors have made use of several novel approaches to prosecution in the past year.

The U.S. Department of Health and Human Services (HHS) reported a rescission of a September 2020 policy that would require that the secretary of health and human Services sign off on any rulemaking by HHS agencies. Despite the firestorm of criticism that followed the issuance of the September 2020 policy, attorney Jim Shehan, of Lowenstein Sandler, told BioWorld that the rulemaking process will remain exceptionally cumbersome, leaving in place a status quo that itself has been the target of repeated criticism.

The U.S. National Institutes of Health had its hands full with the Rapid Acceleration of Diagnostics (RADx) program as the COVID-19 pandemic unwound, but the agency’s other work on diagnostics is bearing fruit. NIH said Aug. 31 that its collaboration with an academic research institute has led to development of a test that predicts which patients suffering from neurofibromatosis will develop cancers with metastatic potential.

In studies that give new insights into both developmental biology and the origins of melanoma, investigators at Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College have identified the activity of chromatin remodeling protein ATAD2 as necessary for cells with the oncogenic mutation V600E to give rise to melanomas. Involvement of epigenetic factors in cancers, or their targeting, is not new in cancer – as HDAC inhibitors as well as newer drugs such as the EZH2 inhibitor Tazverik (tazemetostat, Epizyme Inc.) demonstrate. But to Richard White and his colleagues, the point of their work is not so much about individual targets.

Abbott Laboratories, has acquired Walk Vascular LLC, a deal that brings two devices for peripheral thrombectomy to the Abbott portfolio for peripheral artery disease (PAD). Walk’s two Jeti peripheral thrombectomy devices are cleared in the U.S. for break-up and removal of soft emboli and thrombus, but are in trial for deep-vein thrombosis (DVT) as well, suggesting that Abbott Park, Ill.-based Abbott has availed itself of a technology that could take a big bite out of one of the deadliest and costliest of all circulatory system pathologies.