Articles related to FDA

The Food and Drug Administration has approved digital therapeutics, but insurance coverage has remained a problem. Some businesses have pushed for patient pharmacy benefits to pay for their software-based therapies, but AppliedVR is going in a different direction. A new HCPCS (Healthcare Common Procedure Coding System) code that describes the company’s treatment as a virtual reality cognitive behavioral therapy device with pre-programmed therapy software was granted by CMS to the company. The program complied with all five criteria set forth by CMS to qualify as durable medical equipment.

The Abbott Alinity I TBI test is a laboratory-based test that measures ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein, two biomarkers in the blood that have been linked to brain injury when present in high concentrations. The test has a sensitivity of 96.7% and a negative predictive value of 99.4%. The availability of a blood test provides clinicians with an objective method to quickly evaluate patients with mTBIs while eliminating the need for a head CT scan, potentially reducing health care costs and minimizing emergency department wait times.

The Nerivio device is worn on the arm and uses painless electrical stimulation to activate peripheral nerves, thereby inducing a conditioned pain modulation response. It is controlled by a smartphone app and is recommended to be used every other day for migraine prevention.

The every-other-month intra-ocular injection shows a reduction in lesion growth that increases over time. The ocular formulation of the drug, previously approved for paroxysmal nocturnal hemoglobinuria, should be available in specialty pharmacies in March 2023.

The SGLT2 inhibitor bexagliflozin is now available under the brand name Brenzavvy. Approval was based on monotherapy trials versus glimepiride, where the new drug was non-inferior, and in combination with metformin.

Emzahh (norethindrone tablets), the progestin-only generic equivalent of the discontinued Ortho Micronor, was approved via an abbreviated NDA.