What Life Sciences Investors Want
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical
A study from the international SONAR trial identified urinary clusterin as a promising biomarker for monitoring the progression of chronic kidney disease (CKD) and assessing therapeutic response, especially in patients...more
During and after the COVID-19 Public Health Emergency, the Centers for Medicare & Medicaid Services (CMS) provided certain flexibilities and exercised enforcement discretion with respect to regulations affecting...more
The McGuireWoods Women’s Health Newsletter delivers information on the latest legal and regulatory developments affecting the women’s health industry. The publication provides timely analysis of legislative changes,...more
The Food and Drug Administration (FDA) has begun 2026 with a clear signal to the direct‑to‑consumer testing industry: self‑collection devices remain firmly within the agency’s regulatory reach, notwithstanding the 2025 court...more
The health care and life sciences sector is entering a period of accelerated transformation shaped by new technologies, shifting regulatory frameworks, and evolving market demands. Foley & Lardner LLP’s “Health Care & Life...more
As part of its calendar year 2026 Medicare Physician Fee Schedule, the Centers for Medicare and Medicaid Services (“CMS”) made permanent a major change to its physician direct supervision rules. Effective January 1, 2026, for...more
Proposes to develop a freestanding, non-hospital-based, multi-specialty ambulatory surgery center (ASC) with an associated Medicare-certified independent diagnostic testing facility at the Riverwalk Health and Wellness...more
The EU Commission has published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) on 16 December 2025, which can be accessed...more
Amid rapid technological advancements and regulatory uncertainty, navigating the life sciences ecosystem can be challenging. In the video above, Chelsea Anderson, Rob Freedman, and Amanda L. Rose share what life sciences...more
Diagnostic errors are alarmingly common—and they can be extremely dangerous. According to Johns Hopkins Medicine, “[w]hile estimates vary, likely more than 100,000 Americans die or are permanently disabled each year due to...more
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases...more
On July 2, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-07, which concluded that a pharmaceutical manufacturer’s proposed arrangement to sponsor a free,...more
When most people think about the lingering effects of a concussion, they picture persistent headaches, light sensitivity, or forgetfulness. ...more
On Tuesday, September 23, 2025, FDA published guidance titled “Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency.” The guidance, a draft of which was published on May...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more
In attempt to deliver more effective and affordable care, Oracle, Cleveland Clinic, and G42 have announced a strategic partnership that will build a global AI-powered healthcare platform....more
Join us for Bricker Graydon’s WIN event, as we bring together friends and colleagues to mix and mingle, and to raise awareness about what is happening with breast cancer in our community....more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Pharmaceutical company sponsorship of diagnostic testing remains an area with a gaping divide between the views of regulators and industry, with regulators focused on potential fraud and abuse concerns while industry...more
The adoption of artificial intelligence (AI) in healthcare has ushered in a new era of innovation that is transforming diagnostics, treatment planning and operational efficiencies. However, with great potential comes...more
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more