Medical Device Legal News with Sam Bernstein: Episode 9
Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more
Secure your place today for ACI's Inaugural West Coast Summit for Women Leaders in Life Sciences Law. Join industry leaders from pharmaceuticals, biotech and MedTech for an immersive two-day event that explores practical...more
- What is new: DOJ announced a $9.8 million FCA settlement with Illumina Inc. to resolve claims arising out of alleged cybersecurity deficiencies in DNA sequencing systems Illumina sold to government agencies. - Why it...more
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
As noted in the first article in our Medtech Coming to America series, “US Emerging as Top Global Medtech Destination,” perceived regulatory advantages are prompting European medtechs to enter the US market earlier in their...more
The doctrine of equivalents (DOE), a creation of the Supreme Court in Graver Tank & Mfg. v. Linde Air Products (1950), is balanced by the concept of prosecution history estoppel (PHE), the contours of which were delineated...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
Partner Dan Shores will present a webinar titled "mRNA Patent Wars Update: Litigations Expand and Key Rulings Expected in 2025" for Medmarc, the leading expert in the products liability risks facing medical technology and...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
For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...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
Excitement is building as C5’s inaugural European Summit For Women Leaders in Life Sciences Law gets closer. Make plans to join women at the forefront of life sciences law as they address legal, regulatory, and policy...more
The medtech sector is showing promising signs of recovery in both mergers and acquisitions (M&A) activity and venture capital (VC) investments....more
As we outlined in our previous blog article, California recently became the second state to enact a law safeguarding consumer brain data, following a similar law passed by Colorado in April. Both state laws prevent the sale...more
In this episode of On Record PR, Gina Rubel goes on record with Kathleen Fisher Enyeart, Counsel at Lathrop GPM, to discuss the challenges of complying with health care regulations in a complex and rapidly changing industry....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
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
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
Hosted by American Conference Institute, the 2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities returns for another exciting year with curated programming that will highlight leveraging...more
DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
Of Counsel James Hastings will present a webinar titled "Managing Risks through IP Innovation Management Training" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
Partners Jenny Colgate and Jennifer Maisel will present a webinar titled "Artificial Intelligence Litigation Risks for the Medical Technology Industry" for Medmarc, the leading expert in the products liability risks facing...more