FDAnews Device Daily Bulletin

Roche Molecular Systems is preparing a September launch for the first FDA-approved DNA test to measure viral load of cytomegalovirus (CMV) in solid organ transplant patients undergoing antiviral treatment.

As Taiwan and South Korea apply health technology assessment (HTA) to sift out the costs versus benefits of new drugs and medical devices, other Asian countries, such as China, are looking at ways to adopt such cost-cutting programs, a pair of recent industry surveys suggests.

Cardiovascular medical devices maker St. Jude Medical reported a profit for the second quarter that edged up from last year, driven mainly by lower restructuring charges.

Steris will buy privately held diagnostics company US Endoscopy for $270 million in cash in order to expand in the gastrointestinal endoscopy market.

EquinoxO2 Medical announced development and distribution of its HALO XP pump system.

Kips Bay Medical announced it has filed an application for an investigational device exemption with the FDA to include four U.S. sites in its eMESH I clinical feasibility study of its eSVS mesh device currently being pursued in Europe.

CellAegis Devices announced that it has received a CE Mark for the autoRIC device.

Galway-based Neuravi has announced that it expects to create 25 new jobs over the next three years as a result of a $6.4 million investment.