Glaukos Corp. brought home a nice year-end gift for investors with a broad U.S. FDA approval for the Idose TR. Indicated for use in patients with primary open-angle glaucoma or ocular hypertension across the full range of disease severity, the device/drug combo provides continuous release of a prostaglandin analog that reduces intraocular pressure via a titanium device implanted through a corneal incision for up to three years.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Quidelortho, Ulrich Medical.
The Securities and Exchange Commission (SEC) charged Laura Tyler Perryman, the former CEO and co-founder of Stimwave Technologies Inc., with defrauding investors out of approximately $41 million by making false and misleading statements about one of the company’s products. According to the SEC’s complaint, the Stimwave device comprised several components, one of which was a fake, non-functional component that was implanted into patients’ bodies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perfuze, Vivos.
The holidays are looking brighter for Masimo Corp. with two bits of good cheer this week for the company. Apple Inc. confirmed to BioWorld that it will preemptively pull two smartwatches from its website and retailers in response to a Masimo infringement case that persuaded the International Trade Commission to block their import.
Both the U.K. MHRA and the U.S. FDA approved their first CRISPR-based gene therapy in 2023. Crispr Therapeutics AG and partner Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) was approved by the MHRA in November and the FDA on Dec. 8. The U.K. approval is for both severe sickle cell disease (SCD) and transfusion-dependent thalassemia (TDT). In the U.S., the approval is for severe SCD, with a PDUFA date for TDT coming up in spring 2024.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioamerica, Masimo, Neuronetics, Tyber Medical, Fuse-AI.
Neuroone Medical Technologies Corp. received U.S. FDA 510(k) clearance for its Onerf ablation system which is capable of both recording electrical activity and ablation of nervous tissue.
After years of battling to retain its hold on Grail Inc., Illumina Inc. finally announced that it will be unwinding the ill-fated acquisition of the multi-cancer early detection test maker. In addition to stiff opposition from activist investor Carl Icahn that cost Illumina’s previous CEO and board chair their positions, European and U.S. regulators have consistently opposed the deal.