Abbott Laboratories emerged early on in the pandemic as a leading test maker for the virus that causes COVID-19. Now, the company is going on the defensive after The New York Times reported that the company instructed workers at its Westbrook, ME-based factory to discard materials used for making its rapid COVID-19 test, the BinaxNOW. Abbott said the discarded materials were at their seven-month shelf life and were disposed of in accordance with the company's standard inventory management process.
European regulators raised a brow at Illumina's decision to complete its acquisition of Grail. Illumina said it would hold Grail as a sepearate company until antitrust investigations were complete, but the European Commission said that's not good enough. The regulatory body opened an investigation to assess whether Illumina breached the "standstill obligation."
Declining COVID-19 testing volume has led LumiraDx to reduce the terms of its valuation for its Special Purpose Acquisition Corporation (SPAC) merger with CA Healthcare Acquisition Corp. The London-based company is taking the valuation from $5 billion to $3 billion.
And in case you missed our last Medtech in a Minute report...
After enduring much regulatory scrutiny, Illumina has acquired Grail, the liquid biopsy company it launched in January 2016. The firm is holding Grail as a separate company during the European Commission’s ongoing regulatory review. The deal first came under scrutiny by the Federal Trade Commission earlier this year as FTC said the acquisition would diminish innovation in the U.S. market for multi-cancer early detection tests. The European Commission soon followed suit, but Illumina fired back – filing an action to annul the European Commission’s decision. European regulators are still reviewing the merger, even though Grail does not conduct business in the European Union.
FDA alerted patients, providers, and medtech manufacturers that cybersecurity vulnerabilities reported by BlackBerry may affect certain medical devices. The company reportedly kept the software flaw secret for months.
FDA has approved the Amplatzer Amulet Left Atrial Appendage Occluder to treat U.S. patients with atrial fibrillation who are at risk of ischemic stroke. The device will compete directly with Boston Scientific's Watchman device in the U.S. left atrial appendage closure market. Analysts expect Amulet to see rapid adoption in the U.S. market, based on the device's European experience.