Hologic Inc.’s focus on women’s health is looking like a brilliant move as the company lands U.S. FDA clearance for its Genius digital diagnostics system with the Genius cervical artificial intelligence algorithm, making it the first digital cytology system with clearance, the company said.
After winning a brutal proxy battle led by activist investor Carl Icahn, Francis deSouza suddenly resigned as CEO and as a member of the board of Illumina Inc. over the weekend. The company appointed General Counsel Charles Dadswell to serve as the interim CEO while it evaluates internal and external candidates for the position. DeSouza will continue in an advisory role until July 31.
The U.S. Preventive Services Task Force (USPSTF) is proposing to lower the age of onset of regular breast cancer screening to 40 years, a massive jump of 10 years over the current recommended age of 50 years. While this is just a draft proposal, analysts who track the medical device industry say that medical imaging manufacturers, such as Marlborough, Mass.-based Hologic Inc., could see a significant uptick in demand for their systems, a much-needed boost as the drop in demand incurred by the COVID-19 pandemic comes to an end.
The doctrine of patent assignor estoppel is not found in the U.S. statute, but that omission has led to only limited litigation over the doctrine despite the notoriety of the case of Hologic v. Minerva. Nonetheless, the Federal Circuit reinforced the understanding that an assigned patent is still in force when the disputed claim is not seen has having been materially broadened by the time a patent has been granted in its final form, thus closing one of the principal contractual questions surrounding patents that are handed off from one device maker to another.
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
The American Society of Clinical Oncology (ASCO) updated its guidelines to recommend use of Biotheranostics Inc.’ Breast Cancer Index (BCI) molecular gene-expression test to aid decisions on extended endocrine therapy in certain patients with the most common type of breast cancer.
The FDA continues to issue new and revised emergency use authorizations for testing for the COVID-19 pandemic in recent days, including three reissued and four revised EUAs dated March 24.
With today’s announcement of its planned acquisition of Bolder Surgical LLC for $160 million, Hologic Inc. continues to execute on the strategy laid out in early January to use the strong cash flow from COVID-19 diagnostics to expand its core business. The Bolder deal, expected to close by Dec. 31, represents the fifth acquisition of 2021. Bolder is a developer of advanced energy vessel-sealing surgical devices.
The Supreme Court of the U.S. delivered its decision in the case of Minerva v. Hologic, a case that tested the boundaries of the doctrine of assignor estoppel, which bars a patent's seller (assignor) from attacking the patent's validity in subsequent patent infringement litigation.
The Supreme Court heard the case of Minerva Surgical Inc. v. Hologic Inc., which takes up the question of assignor estoppel for patents, but the discussions that peppered the April 21 hearing lent little clarity as to how the nine justices will decide the case.