A hearing app compatible with Apple's AirPods Pro 2 and above has been approved as a digital medical device.
The Korea Food and Drug Administration announced on the 19th that it approved a total of 185 medical products in July. Among them, the 'Hearing Aid Feature (HAF)', a software for otolaryngology, was approved as a digital medical device. This app amplifies sound through wireless earphones for people with mild to moderate hearing loss.
According to the Korea Food and Drug Administration, the number of approved medical products last month increased by 149.2% compared to the average of 124 items per month last year and by 158.1% compared to the average of 117 items per month so far this year. The approved medical products include 61 pharmaceuticals, 6 items classified as non-pharmaceutical products, and 118 medical devices.
The Korea Food and Drug Administration approved the following new drugs: △ Prostacyclin injection (Flotupolastat) for diagnosing prostate cancer △ 'Itobevi 3 mg (Inavolisib)' as a breast cancer treatment △ Itobevi 9 mg (Inavolisib) △ Winlev Air Kit injection 60 mg (Sotatercept).
It also approved 'Icavobrune 80 mg (Elafibranor)', a treatment for primary biliary cholangitis, as a rare medicine.
A representative from the Korea Food and Drug Administration noted, 'We plan to continue to rapidly approve safe and effective products to consistently expand treatment opportunities for patients and to strengthen the transparency and reliability of medical product approval reviews.'