About The Leading Medical Equipment Manufacturer in Miami, FL
Histo is the leading medical equipment manufacturer in Miami, FL. The company was founded in 1994, whose primary purpose is to manufacture products designed for interventional medical procedures in radiology, urology, nephrology, mastology, and gynecology.
Our goal is to provide hospitals and medical centers with interventional products of the highest caliber. These products include BIOCORE II, BIOCORE II MG, BIOCORE II BR, DANA 2.2 MG, MAMAWIRE, and BLO-K, which are globally recognized as biopsy needles, automatic biopsy guns, and breast localization needles.
Each stage of our manufacturing process is carried out in accordance with current standards. Our class 10,000 clean room meets the highest sanitary requirements and is subject to periodic certification of its sectors.
Continuous compliance with these tasks has allowed the certification of Good Manufacturing Practices (GMP) for medical products to be granted by the National Administration of Drugs, Food and Medical Devices (ANMAT), with the approval of registration from the US Food and Drug Administration (FDA) - registration no. 3004857851.
We have a team of professionals dedicated to controlling and improving our quality system who seek the permanent improvement of our manufacturing methods.
The raw materials used in all of our products meet strict quality requirements.
Histo's quality system is certified by ISO 13485: 2016/ISO 9001: 2015.
We operate according to national and international quality regulations set by the FDA and the GMP-ANMAT.
The Maker of Interventional Medical Tools
Our company is proud to be the manufacturer of Florida interventional medical products. Small, but mighty; these biopsy needles, automatic biopsy guns, and breast localization needles are the little tools that make a big difference for the patient.
Instead of requiring a complicated surgical procedure, these tools allow the doctor to see if surgery is necessary and at what level. The physician may be able to perform a non-invasive procedure or target a smaller area for optimal results.
Focusing on the Minimally Invasive
With interventional medical products, doctors can do more with less. These devices are minimally invasive and thus increase patient safety and decrease patient risk. Advances in science and technology have resulted in the invention of devices, such as those that we make, which are better for doctors and patients alike.
As a matter of fact, these tools have changed the treatment options for several conditions. Using a biopsy needle to see if cancerous cells are present in a cyst impacts the way physicians proceed with a case. Such medical intervention is positive, for it gives doctors the information they need to make sound decisions about what is in the best interest of the patient.