The FDA cleared Thermo Fisher’s in vitro diagnostic for preeclampsia, the leading cause of pregnancy morbidity and mortality, based on results from the PRAECIS study.
Thermo Fisher Scientific is the first company to receive US Food and Drug Administration clearance for a blood test to assess a mother’s risk of severe preeclampsia, the leading cause of pregnancy-related illness and death in the US.
The FDA clearance of these breakthrough biomarkers will have a significant impact on prognosis and treatment for thousands of women at risk for preeclampsia every year in the US, said Alan Sachs, Thermo
Haemonetics will acquire Quebec-based OpSens for CAD $2.90 per share, or about US $253m at current exchange rates. Haemonetics expects OpSens' fiber-optic technology to complement its interventional cardiology portfolio.
The retail giant will sell the Dexcom G7 continuous glucose monitoring system to eligible customers through a new online platform.
Stimdia is trying to restore respiratory function in ICU patients with phrenic nerve stimulation.
Reuters reported that global private equity firm Carlyle Group has offered to pay at least $7bn for Medtronic’s patient monitoring and respiratory interventions businesses. Medtronic announced its plan to get out of those businesses about one year ago.
With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.
The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.
SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.
