Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the skin to deliver alternating electrical fields, termed Tumor Treating Fields (TTFs), thereby disrupting malignant cell division while leaving healthy cells largely unaffected.
Johnson & Johnson to Acquire Shockwave Medical in $13.1B Deal
Johnson & Johnson (J&J) reported on April 5, 2024, that it has entered an agreement to acquire Shockwave Medical, a company in the cardiovascular medical device sector, in a deal totaling a reported $13.1 billion. The deal would further expand J&J into the cardiovascular treatment market.
Updates in the FDA’s Regulation of Digital Health Technologies
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s Automated Impella Controller (AIC), which is part of a medical device system that provides temporary ventricular support to help a patient’s heart to pump blood in a critical care setting.
Knobbe Martens Team Authors “Recent Developments in Intellectual Property Law 2023” For ABA Business Law Today Section
Knobbe Martens attorneys Julia Hanson, Raina Patel, Nyja Prior, and Mengmeng Du co-authored the article “Recent Developments in Intellectual Property Law 2023” for the ABA’s Business Law Today section. Partner...
AI & the FDA
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to analyze vast amounts of patient data and provide diagnoses as well as personalized treatment recommendations. In recent years, the FDA has approved various AI-enabled medical devices, some of which are discussed below.
Report: Medical Device Market Expected to Grow Over Next Seven Years
An article from October 2022 states that the global medical device market is projected to jump by seven billion dollars in 2022 and leap to $223 billion over the next seven years, to reach a valuation of around $719 billion by 2029. A report by consulting firm Fortune Business Insights anticipates a 5.5% compound annual growth rate (CAGR) over this period.
AI and Cancer Diagnostics
Rather than simply reading radiological scans, Ibex Medical Analytics is employing its artificial intelligence (AI)-powered cancer detection solutions to assist pathologists in the lab. Ibex’s Galen Platform is a clinical-grade, multi-tissue platform that helps pathologists detect a variety of cancers and grade their malignancies.
The Applicant-Action (Or Inaction) Exception
GILBERT P. HYATT v. UNITED STATES PATENT AND TRADEMARK OFFICE
Before Moore, Prost, and Hughes. Appeal from the District Court for the Eastern District of Virginia
Summary: For a patent application filed but not yet granted before the Uruguay Rounds Agreement Act (which changed patent terms to be 20 years from the effective filing date instead of 17 years from the grant date), a patentee’s failure to disclose species-altering amendments for decades triggered the applicant-action exception. Therefore, the Examiner was within his authority to impose a restriction requirement under that exception.
Knobbe Martens Welcomes New Class of Associates
Knobbe Martens announces its continued commitment to providing the highest quality legal services with the addition of 30 new Associates firmwide. “Our new associates have a wide range of talents...
