FDA clears Gyrus' RF (radio frequency) generator:
This article was originally published in Clinica
Gyrus has received US FDA 510(k) clearance for its G1 temperature-controlled radio frequency generator for powering the firm's single-patient-use surgical instruments for treating upper airway obstructions, including sleep apnoea, nasal obstructions and habitual snoring. The unit addresses a market opportunity valued in excess of $1 billion in the US alone, says the Reading, UK firm.
You may also be interested in...
As the first emergency use authorization is granted, Pfizer and Moderna stand accused of neglecting poorer nations as wealthy countries snap up early access to COVID-19 vaccines.
The FDA has released final guidance on “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA” for the industry. The guidance brings clarity and aims at facilitating product development meetings between the FDA and the ANDA applicants for complex products.
By handing out free supplements to the clinically vulnerable, the UK government is effectively endorsing the use of vitamin D to reduce the risk and/or severity of COVID-19, although it says more research is needed.