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
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
