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.

The U.S. FDA’s draft guidance for control of thermal effects of medical devices may not have broken new conceptual ground, but two trade associations are of the view that the draft is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.

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.

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.

Astrazeneca plc’s blockbuster Enhertu continued to garner attention as new data released at the American Society of Clinical Oncology (ASCO) annual meeting show the antibody-drug conjugate demonstrated strong progression-free survival in metastatic breast cancer patients. Puma Biotechnology Inc. had advances of its own at ASCO with new biomarker findings from a phase II study of alisertib, an aurora protein kinase 2 inhibitor, in endocrine-resistant metastatic breast cancer.

Edwards Lifesciences Corp. is selling its critical care product group to Becton Dickison and Co. (BD) for $4.2 billion in cash, forgoing its previously announced plans to spin off the unit into a separate business. The transaction is expected to close before the end of the calendar year.