LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) is inviting manufacturers to submit electronic cigarettes for approval as medical devices, after drawing up new guidance on the standards that will be required for approval. The move means the U.K. could become the first country in the world where e-cigarettes are available on prescription as smoking cessation aids.
Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.
HONG KONG – Tokyo-based Cureapp Inc. has received the Ministry of Health, Labour and Welfare (MHLW)’s green light to manufacture and sell Cureapp SC [Smoking Cessation] Nicotine Addiction Treatment App and CO Checker, its therapeutics app to aid patients who are quitting smoking.
The U.S. FDA has given the green light to a new type of treatment to help smokers quit, clearing the way for the first time the use of deep transcranial magnetic stimulation (Deep TMS) for short-term smoking cessation in adults.
Jerusalem-based Brainsway Ltd. had good news to report with the presentation of positive data from a multicenter study evaluating its deep transcranial magnetic stimulation (dTMS) system as an aid in smoking cessation.