FDAcop, Author at FDA Copilot

July 5, 2023 Artificial Intelligence FDAcop

La FDA ofrece detalles actualizados sobre la propuesta del programa de alimentos humanos unificado, incluyendo el reciente enfoque para la Oficina de Asuntos Regulatorios.

The U.S. Food and Drug Administration (FDA) has provided an update on its proposal to create a unified Human Foods Program (HFP) which includes a new model for the Office of Regulatory Affairs (ORA). These additions to the FDA commissioner’s proposal, announced earlier this year, will further enhance coordination, prevention, and response activities throughout the […]

July 5, 2023 Artificial Intelligence FDAcop

Article Exclusively Authored by Industry Regulators

The FDA has released a final guidance on how companies should present quantitative information about the risks and effectiveness of drugs in direct-to-consumer advertising. The guidance, which was cleared by the White House four months ago, includes changes in the way information about control groups should be presented in drug advertisements. The FDA’s Center for […]

July 4, 2023 Artificial Intelligence FDAcop

FDA Grants Approval for First Cellular Therapy to Treat Type 1 Diabetes Patients

The U.S. Food and Drug Administration (FDA) has approved Lantidra, a cellular therapy made from deceased donor pancreatic cells, for the treatment of type 1 diabetes. Lantidra is intended for adults with type 1 diabetes who are unable to achieve target blood glucose levels due to severe hypoglycemia (low blood sugar) despite intensive management and […]

July 4, 2023 Artificial Intelligence FDAcop

Gratitude Expressed for Life Sciences Analysis

July is expected to be a slow month for regulatory actions, with only a small number of FDA-hosted and industry-hosted meetings scheduled. There are also not many legislative or user fee-driven deadlines for the FDA to meet. However, when the FDA released its updated Unified Agenda in June, it listed several regulations that it expected […]

July 4, 2023 Artificial Intelligence FDAcop

First Gene Therapy for Severe Hemophilia A in Adults Approved by FDA

On June 29, 2023, the U.S. Food and Drug Administration (FDA) approved Roctavian, a gene therapy for the treatment of severe hemophilia A in adults without pre-existing antibodies to adeno-associated virus serotype 5. Severe hemophilia A is a rare genetic bleeding disorder that affects primarily males and is characterized by low levels of clotting Factor […]

July 4, 2023 Artificial Intelligence FDAcop

In-Depth Examination of Life Sciences by Regulatory Experts

In the month of July, regulatory professionals and industries that follow FDA regulations can expect a slower pace of activity. Generally, regulatory actions tend to slow down during the summer months, and July seems to be no exception. The FDA, like many other organizations, appears to be affected by the summer slowdown. This means that […]

July 4, 2023 Artificial Intelligence FDAcop

The FDA’s Latest News: June 30, 2023

The U.S. Food and Drug Administration (FDA) provided an update on various developments within the agency on June 30, 2023. Firstly, the FDA’s Center for Tobacco Products (CTP) Director Brian King shared a statement summarizing the center’s progress in addressing the evaluation of CTP by an independent expert panel facilitated by the Reagan-Udall Foundation (RUF). […]

July 4, 2023 Artificial Intelligence FDAcop

Augmedics secures $82.5M to develop an augmented reality platform for spine surgery

Augmedics, an augmented reality surgical-navigation platform, has raised $82.5 million in Series D financing led by CPMG. The funding round also included participation from Evidity Health Capital, as well as current investors Revival Healthcare Capital, H.I.G. Capital, Almeda Ventures, and others. Augmedics’ flagship product, the xvision Spine System, received FDA clearance in 2019. This system […]

July 4, 2023 Artificial Intelligence FDAcop

Latest News: Medical IP’s AI Body Composition Analysis Software Clears US FDA’s Roundup alongside other briefs

Medical IP, a South Korean medical imaging company, has received FDA clearance for its AI-powered body composition analysis software. The software, called DeepCatch, automatically analyzes body components through whole-body CT scans and provides 3D visual and quantitative information. Indian health tech company Augnito has introduced ambient technology for clinical documentation. The technology transcribes doctor-patient consultations […]

July 4, 2023 Artificial Intelligence FDAcop

CPT III code granted to icometrix, an AI-enhanced brain imaging company

Belgium-based AI company icometrix has received a CPT III code from the American Medical Association, allowing reimbursement for its FDA-cleared brain MRI quantification software. The software provides metrics for cerebral MRI scans to aid clinicians in diagnosing and monitoring neurological conditions such as Alzheimer’s disease, multiple sclerosis, and Parkinson’s disease. This code will enable healthcare […]

Author: FDAcop