The U.S. FDA and Department of Justice have announced a consent decree entered into district court that enjoins Philips Respironics LLC North America from manufacturing and distributing respiratory devices from three company facilities in the state of Pennsylvania. Read More
Australia’s Speedx Pty Ltd. is launching a new rapid polymerase chain reaction (qPCR) test for 14 different respiratory viruses in a single test that works on almost every commercial PCR platform in half the time and at a fraction of the cost of what its competitors charge. Read More
Exact Sciences Corp., Seekin Inc. and Serum Detect Inc. presented encouraging results for the field of multicancer early detection at the American Association for Cancer Research annual meeting in San Diego April 6-10, but delays in coverage may slow further progress. Read More
Australia’s Therapeutic Goods Administration decided to take another look at the regulatory definition of the clinical decision support (CDS) system, a move driven by technological advances and some confusion as to what type of CDS is exempt from registration requirements. Read More
Eli Lilly and Co. continues its development of an oral drug delivery device that can successfully deliver a drug that would otherwise be ineffective when taken orally. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 16Bit, Labcorp, Raydiant, Roche. Read More
