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.
And in case you missed our last Medtech in a Minute report...
Nanox Imaging has agreed to acquire Zebra Medical Vision, an artificial intelligence specialist, for up to $200 million ($100 million upfront, $100 million more in potential milestone payments). The company also plans to acquire USARAD and its related company, Medical Diagnostics Web, for $30 million.
Hagar, an Israel-based company developing continuous glucose monitoring (CGM) technology inspired by a spilled cup of tea, raised $11.7 million in a series B round. The company has now raised $17.1 million, following a $4.4 million series A round earlier this year. Proceeds from the latest financing will support clinical trials and completing international patents for the GWave CGM technology.