Consolidation in diagnostics continues apace, with Diasorin SpA set to take over Luminex Corp. in an all-cash deal that values the multiplex diagnostics and molecular testing specialist at $1.8 billion. At $37 per share, the price is a 23% premium to the Luminex (NASDAQ:LMNX) share price on Feb. 23, which is when rumors of the acquisition began to circulate, and 12% above the close last Friday, April 8. Read More
Endologix LLC said Tuesday that it has completed the acquisition of Pq Bypass Inc., a privately held company developing a novel technology for treating severe peripheral artery disease (PAD). Pq Bypass’ Detour system is currently being studied in a U.S. and European clinical trial, DETOUR2. Read More
Memic Innovative Surgery Ltd. secured a major cash infusion to bring its freshly FDA-authorized Hominis robotic-assisted surgical platform to market. Peregrine Ventures and Ceros led the $96 million series D financing round with participation from Ourcrowd and Accelmed. Read More
The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access. Read More
PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience. The objective of the government’s modern manufacturing strategy is to build scale and capture income in high-value areas of manufacturing where Australia either has established competitive strength or emerging priorities. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Burning Rock, Cardialen, Cofactor Genomics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agena Biosciences, Biocorp, Cardinal Health, Davos Health, Emed, Ethos Laboratories, Genscript, Molecular Matrix, Prexa Santé, Roche, Truepill. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Hemanext, Lumiradx. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE needs more evidence for Clarity RMS for AKI; Thermacor disposable sets recalled. Read More
Keeping you up to date on recent developments in oncology, including: NIH drug screening protocol identifies treatment for SCLC; Explanation for DR5 antibody problem surfaces; Location, location, location in avoidance of esophagitis. Read More
