Breakthrough designation is given to devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, according to the FDA. The three areas with the most breakthrough designations are cardiology, neurology and orthopedics.
Here is a breakdown of breakthrough designations by clinical panel:
Cardiovascular: 158
Neurology: 114
Orthopedic: 71
Gastroenterology and urology: 47
General and plastic surgery: 43
Anesthesiology: 32
Immunology: 31
Clinical chemistry: 27
Molecular genetics: 24
Pathology: 23
Microbiology: 20
Radiology: 17
Ophthalmic: 17
Hematology: 8
Physical medicine: 7
ENT: 6
General hospital: 4
Obstetrics: 4
Dental: 3
Clinical toxicology: 1
