The €1.5 million ($US1.63 million) in pre-seed funding recently raised by En Carta Diagnostics SA is “key” for the company to be able to develop its point-of-care molecular diagnostics kits and generate clinical data, Guillaume Horreard, CEO at En Carta told BioWorld. Read More
The U.S. FDA’s draft guidance for control of thermal effects of medical devices may not have broken new conceptual ground, but two trade associations are of the view that the draft is nonetheless expansive in a manner that raises serious questions. Read More
A team led by Paul Hergenrother at the University of Illinois, Urbana Champaign (UIUC) has developed a novel antibiotic named lolamicin that was specific for gram-negative bacteria but did not harm the gut microbiome composition in mouse models. Read More
The U.S. FDA has received a citizen petition to grant over-the-counter status to continuous positive airway pressure (CPAP) machines, an oddly timed petition given a recent enforcement action against one of the prime movers in the CPAP space. Read More
Researchers from The Cleveland Clinic Foundation continue to build intellectual property to protect their invention of a portable device for regulating the flow of cerebrospinal fluid (CSF) from a patient. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Concertai, Delfi Diagnostics, Guardant Health, Myriad Genetics, Veracyte. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Evolution Optiks, Genetic Signatures, Zeto. Read More
