Medical Device Legal News with Sam Bernstein: Episode 9
On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more
Connected technology products are a part of daily life. Connectivity standards – such as 5G and Wi-Fi – provide a common language that allows products from different manufacturers to communicate with each other. ...more
A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more
On February 5, 2025, Becton, Dickinson and Company (BD) announced plans to separate its Biosciences and Diagnostic Solutions business into an independent entity. The Biosciences and Diagnostic Solutions business is reportedly...more
On May 9, 2024, the U.S. Department of Justice’s Antitrust Division (DOJ) announced it is “upping [its] game” on health care enforcement through the Task Force on Health Care Monopolies and Collusion (HCMC). The most recent...more
The recent, rapid advancement of the development of artificial intelligence and machine learning (AI) has revolutionized various industries. It is unsurprising then, that at this year’s South by Southwest Conference (SXSW),...more
While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more
Today’s global healthcare marketplace is marked by unprecedented transformation. This presents both challenges and opportunity to today’s market participants. We know how important it is to structure cross-border investments...more
On March 24th, 2022, the Advanced Medical Technology Association’s (AdvaMed) Board of Directors approved updates to the AdvaMed Code of Ethics (Code), which provides guidance to the health care industry on interactions...more
On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021, acquiring Hillrom (a global medical equipment maker headquartered in Chicago) for a purchase...more