Bruker Corp. shows no sign of slowing its buying binge, picking up Nanostring Technologies Inc. for $392.6 million in cash plus the assumption of certain liabilities in its seventh deal so far this year.
Nanostring entered bankruptcy in February and received a “stalking horse” bid of $220 million from private equity fund Patient Square Capital in March. Bruker won the competitive auction for Nanostring’s assets, besting the Patient Square bid by 78%. The deal is expected to close in early May.
The U.S. FDA granted Scopio Labs Ltd. de novo clearance for its artificial intelligence (AI)-powered software which analyzes bone marrow. Scopio’s Full-Field Bone Marrow Aspirate (FF-BMA) system aims to improve patient care by standardizing bone marrow aspirate analysis and elevating diagnostic precision. Read More
One of the problems with the European Union’s Artificial Intelligence Act is that it spans all sectors of the E.U. economy, an approach that Sen. Bill Cassidy (R-La.) suggested is less than optimal in remarks to this year’s meeting of the Medical Device Manufacturers Association. Nonetheless, Cassidy said some in the Senate are keen to pass legislation without taking proper stock of the lack of congressional expertise, which runs the risk that hasty legislation may create more problems than it solves. Read More
Despite the bullish outlook in its quarterly earnings call, which included raising the midpoint of its full-year guidance range, Abbott Laboratories stock slipped on its light second-quarter outlook. Read More
While the U.S. FDA’s final rule for regulation of lab-developed tests (LDTs) has yet to emerge, there is some reason to expect the rule will be met with litigation from clinical lab associations. The FDA’s Jeff Shuren said in remarks to this year’s meeting of the Medical Device Manufacturers Association that there is a legitimate problem with the accuracy of many LDTs, adding that while stakeholders are at liberty to question the FDA’s rulemaking, the agency’s experience in this area indicates that the question of LDT reliability is not up for debate. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agitated Solutions, Lumicell. Read More