article thumbnail

9 Technologies That Will Shape The Future Of Dentistry

The Medical Futurist

For dentists, it’s transforming diagnosis, decision-making, and treatment planning. Computer-assisted design (CAD) and computer-assisted manufacture (CAM), including 3D-printing, are already revolutionising the sector; they are turning them into low-cost, more effective digital labs.

Patients 126
article thumbnail

Is my Software a Medical Device? Use the Digital Health Policy Navigator

FDA Law

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.” The flowchart can be downloaded here.

Medical 23
article thumbnail

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law

Regulatory Background FDA regulates and generally requires premarket approval of all new drugs, which are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.” 21 U.S.C. §

Clinic 59