US FDA office in India may not speed up certifications, approvals for domestic cos (PharmaBiz)
Although the US FDA office in India may start its operations in the next few months, that is unlikely to expedite the disposal of approvals of Indian companies as expected, it is learnt.

AdvanDx Receives FDA 510(k) Clearance For GBS PNA FISH(R) For Rapid Detection Of Group B Strep From Lim Broths (Medical News Today)
AdvanDx announced it received FDA 510(k) clearance for GBS PNA FISH for detection of Streptococcus agalactiae, aka Group B Strep, from turbid Lim Broths inoculated with vaginal and rectal swabs obtained from pregnant women between 35 and 37 weeks gestation.

Signostics Receives FDA Clearance For World's Smallest Ultrasound Product (Medical News Today)
Pioneering medical device company Signostics announced it has secured clearance from the U.S. Food and Drug Administration (FDA) for its palm-sized personal ultrasound device, the 'Signos'. Signostics has developed a cost-effective device that for the first time makes it affordable for individual health professionals to use ultrasound in their clinical practice.