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Sep 29, 2023 Heard on the Street: FDA Reported to Have Granted First Breakthrough Device Designation for a Radiology Triage Tool By Tom Greeson Sung Park On September 13, 2023, a manufacturer of radiology software solutions – Annalise.ai – announced that FDA granted a breakthrough...
Mar 13, 2023 FDA unveils major new changes to its mammography quality standards regulations, and mandates reports to patients about their breast density By Tom Greeson On March 10, 2023, the U.S. Food and Drug Administration (FDA) published in the Federal Register a long-awaited final rule to update...
Jan 04, 2023 Sesame is now a major food allergen By Cori Goldberg Happy New Year. To ring in 2023, we can now add sesame to the list of allergens, which means new labels; revisiting marketing claims;...
Apr 12, 2022 FDA sends open letter to health care providers regarding use of AI imaging software designed to speed prioritization of potential stroke cases By Tom Greeson On April 11, 2022, the U.S. Food and Drug Administration (FDA) issued an open letter to health care providers reminding them about the...
Apr 04, 2022 FDA updates thyroid monitoring guidance for babies and young children who receive injections of iodine-containing contrast media for medical imaging By Tom Greeson The U.S. Food & Drug Administration (FDA) has issued a new warning that adds to the agency's prescribing information when iodinated...
Nov 30, 2021 FDA receives comments on making information about AI/ML-enabled medical devices more transparent By Tom Greeson In response to the U.S. Food and Drug Administration's (FDA's) virtual public workshop on transparency surrounding artificial...
Nov 17, 2021 HHS Reverses Policy on Laboratory Developed Tests (LDTs) By Cori Goldberg There was a meaningful update from the U.S. Department of Health and Human Services (HHS) yesterday regarding FDA’s regulation of...
Nov 03, 2021 FDA releases joint AI/machine learning guidelines with public health partners in Canada and the U.K. By Tom Greeson The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency...
Sep 30, 2021 FDA clears new photon counting CT technology By Tom Greeson This morning, September 30, the U.S. Food and Drug Administration (FDA) cleared what the FDA describes as the "first new major...
Sep 27, 2021 FDA posts new resource for locating approved AI/ML-enabled medical devices By Tom Greeson The U.S. Food and Drug Administration (FDA) has begun to gather and publish a list of medical devices that are enabled through software...
Aug 11, 2021 FDA announces plans to regulate certain diagnostic imaging agents as devices, not drugs By Tom Greeson In a notice published in the Federal Register on August 9, 2021, the U.S. Food and Drug Administration (FDA) announced it will implement...
Aug 09, 2021 FDA announces product recall for certain batches of ultrasound gel By Tom Greeson The Food and Drug Administration (FDA) has published a recall notice from Eco-Med Pharmaceuticals, Inc., a Canadian company, for certain...
May 26, 2021 Due diligence - the steady constant in a changing deal landscape By Cori Goldberg As part of our firm's digital white paper, "Outlook: U.S. Health Care 2021", my colleagues Ari Edelman, Sung Park and I authored a piece...
May 21, 2021 FDA: implantable and other medical devices may harm patients if worn in MR environment By Tom Greeson This week, the Food and Drug Administration (FDA) issued a comprehensive guidance document on the testing and labeling of medical devices...
May 12, 2021 Ultrasound organizations rally to support use of ultrasound contrast agents By Tom Greeson Following a recent warning from the US Food and Drug Administration (FDA) on the safety of certain ultrasound contrast agents (UCAs)...
Apr 27, 2021 Ultrasound contrast agents: safe or unsafe? By Tom Greeson Last week, the US Food and Drug Administration (FDA) issued a notice that certain ultrasound contrast agents containing polyethylene...