XTalks

APRIL 3, 2025

European AI med tech company AZmed received two new FDA clearances for its AI-powered chest X-ray tool, AZchest. The FDA approved AZchest applications to detect lung nodules and triage cases involving pneumothorax and pleural effusion. The company rebranded the name of its AI suite from Rayvolve to AZchest.

Radiology 71

Radiology FDA Approval Marketing Trials 71

XTalks

OCTOBER 1, 2024

GE HealthCare’s newly US Food and Drug Administration (FDA)- approved flurpiridaz F 18 positron emission tomography (PET) radiotracer, Flyrcado, could offer a new approach to diagnosing coronary artery disease (CAD). These products exemplify the company’s ongoing efforts to advance molecular imaging.

FDA Approval 105

FDA Approval Drugs Manufacturing Production 105

XTalks

JANUARY 26, 2024

As of October 19, 2023, there were 692 FDA-approved devices linked to AI/ML , underscoring the expanding role of these technologies in healthcare. It promotes unique insights and improvements in tumor biology understanding through the collaboration of biological and computer scientists.

Research 118

Research Gene Editing Gene Genetics 118

XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

XTalks

AUGUST 30, 2022

Nusinersen was the first FDA-approved treatment for spinal muscular atrophy (SMA), the first approved nucleic-acid therapeutic for a neurologic disease and the first approved drug to correct defective splicing. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

Trials 83

Trials Drug Delivery Drugs Gene 83

XTalks

JUNE 30, 2023

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, head of Radiology Research and Development at Bayer, in the company’s news release. “We

FDA Approval 98

FDA Approval Radiology Trials Life Science 98

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98