According to the agency representative,
Posted: Sat Jan 18, 2025 6:54 am
These types of medical devices have proven themselves to be positive in responsible medical practice, “even when used on only one area of the body: the scalp.”
At the same time, despite the similarity of ATG-01 with a foreign analogue, which is aimed at eliminating hair loss after chemotherapy, Roszdravnadzor specifically emphasizes that the Russian device “is not intended to prevent alopecia.”
“If medical devices with similar operating principles gain experience in new purposes, areas of application, and indications for use, then registered medical devices can declare expanded purposes, areas, and indications for use in the instructions for use by going through the procedure of amending the registration dossier with confirmation of the estonia whatsapp number list declared new information in the manner prescribed by law,” Roszdravnadzor explained.
What the experts say
The experts interviewed by the Runet editorial staff refused to give an authorized comment, citing the fact that there are not many specialists on the market and they did not want to spoil relations with anyone, as well as go against the official position of Roszdravnadzor and the bosses who were engaged in purchasing the device for "their own reasons" and because of the ban on communicating with journalists bypassing the press service. Therefore, they spoke about their own experience of working with the ATG-01.
Several doctors interviewed by RuNet stated that the device was not effective for their purposes and “is sitting in a closet unused.”
After receiving the device, we were unable to start it. It was broken. So we had to return it to the suppliers, who returned it to us in working condition after several months, - said the deputy head of one of the large regional clinics.
According to him, even after receiving the ATG-01, doctors were unable to use it in their work, since the device "could not prove its effectiveness." To record the temperature of the brain, medical workers used a sensor to measure intracranial pressure and temperature. However, intensive care patients, after any operations, have a bandage wound around their heads, through which it was not possible to reduce the temperature of the brain.
At the same time, despite the similarity of ATG-01 with a foreign analogue, which is aimed at eliminating hair loss after chemotherapy, Roszdravnadzor specifically emphasizes that the Russian device “is not intended to prevent alopecia.”
“If medical devices with similar operating principles gain experience in new purposes, areas of application, and indications for use, then registered medical devices can declare expanded purposes, areas, and indications for use in the instructions for use by going through the procedure of amending the registration dossier with confirmation of the estonia whatsapp number list declared new information in the manner prescribed by law,” Roszdravnadzor explained.
What the experts say
The experts interviewed by the Runet editorial staff refused to give an authorized comment, citing the fact that there are not many specialists on the market and they did not want to spoil relations with anyone, as well as go against the official position of Roszdravnadzor and the bosses who were engaged in purchasing the device for "their own reasons" and because of the ban on communicating with journalists bypassing the press service. Therefore, they spoke about their own experience of working with the ATG-01.
Several doctors interviewed by RuNet stated that the device was not effective for their purposes and “is sitting in a closet unused.”
After receiving the device, we were unable to start it. It was broken. So we had to return it to the suppliers, who returned it to us in working condition after several months, - said the deputy head of one of the large regional clinics.
According to him, even after receiving the ATG-01, doctors were unable to use it in their work, since the device "could not prove its effectiveness." To record the temperature of the brain, medical workers used a sensor to measure intracranial pressure and temperature. However, intensive care patients, after any operations, have a bandage wound around their heads, through which it was not possible to reduce the temperature of the brain.