Archives

Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.

3D printing is being used for prosthetics, orthodontics, surgical preparation, and other applications. These devices may be subject to FDA regulation, Stark and AKS compliance, and FTC oversight.

Drone technology has many different medical applications including the delivery or medications and medical services. Developers and medical practices need to understand the healthcare compliance [...]

Many metaverse augmented reality, virtual reality, artificial intelligence, and other med-tech applications will need to meet FDA medical device requirements.

As gyms and medical fitness centers expands the services and products they offer and depend more on physician referrals and doctor employment, compliance review becomes a must.

Physicians regularly work with businesses who want the doctors to use their products. To encourage physicians to choose their practice over competitor practices, vendors often offer incentives. [...]

Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA's view, diagnoses and treats disease.

Blogger Patricia Salber, MD MBA featured Understanding whether a medical app needs FDA regulation can be tricky on The Doctor Weighs In. In this videotaped interview, held at the 2015 Stanford [...]

If you want to know where the next healthcare revolution will come from, look inside. Physical medicine becomes virtual medicine, becomes mobile healthcare, becomes wearable health and then [...]

If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?Many clients have asked us: do we have a medical device? Do we need to submit a 510k? [...]