This section highlights FDA-related milestones and regulatory updates for drugs developed by Becton, Dickinson and Company (BDX).
Over the past two years, Becton, Dickinson and Company has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XTRACT™, BD, and GalaFLEX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
XTRACT™ FDA Regulatory Events
XTRACT™ is a drug developed by Becton, Dickinson and Company for the following indication: Peripheral Artery Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XTRACT™
- Announced Date:
- October 9, 2025
- Indication:
- Peripheral Artery Disease
Announcement
BD (Becton, Dickinson and Company) announced the enrollment of the first patient in the XTRACT™ Registry, a prospective, multi-center, single-arm, post-market registry study designed to evaluate the real-world performance of the Rotarex™ Catheter System in the treatment of patients with peripheral artery disease (PAD) lesions.
AI Summary
BD announced the enrollment of the first patient in its XTRACT™ Registry study, a prospective, multi-center, single-arm registry that will examine the real-world performance of the Rotarex™ Catheter System in treating peripheral artery disease (PAD) lesions. The patient enrolled on September 29, 2025, under the care of Dr. Kousta Foteh at Vital Heart & Vein.
With up to 600 patients at 100 U.S. sites, the study will gather safety and effectiveness data at 30 days, 6 months, and 12 months post-procedure to guide PAD treatment strategies.
The Rotarex™ Catheter System combines atherectomy and thrombectomy functions, using a rotating atraumatic head, a vortex effect, and an internal helix to remove plaque and thrombus. “This registry will provide critical real-world evidence,” said Dr. Foteh. Rob Righi, BD’s VP of Vascular Platform, called the enrollment a significant milestone in advancing PAD care.
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BD Veritor™ System FDA Regulatory Events
BD Veritor™ System is a drug developed by Becton, Dickinson and Company for the following indication: For SARS-CoV-2.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BD Veritor™ System
- Announced Date:
- July 30, 2025
- Indication:
- For SARS-CoV-2
Announcement
BD (Becton, Dickinson and Company) announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors' offices, urgent care centers, retail clinics and other convenient points of care.
AI Summary
BD (Becton, Dickinson and Company) announced U.S. Food and Drug Administration 510(k) clearance for its BD Veritor™ System for SARS-CoV-2, a digital test that detects COVID-19 antigens in symptomatic individuals in about 15 minutes. The system uses a chromatographic lateral flow immunoassay and the BD Veritor™ Plus Analyzer to deliver objective, easy-to-read results with a streamlined workflow. It is intended for use in CLIA-waived settings—such as doctors’ offices, urgent care centers, retail clinics and other point-of-care locations—using nasal swab specimens from patients within six days of symptom onset.
Nikos Pavlidis, worldwide president of BD Diagnostic Solutions, said this clearance underscores BD’s commitment to providing reliable, rapid diagnostic tools that help clinicians make timely decisions and improve patient outcomes. The 510(k)–cleared version of the test will fully replace the current version starting in early fall 2025.
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GalaFLEX LITE FDA Regulatory Events
GalaFLEX LITE is a drug developed by Becton, Dickinson and Company for the following indication: In Breast Implant Revision Surgery.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GalaFLEX LITE
- Announced Date:
- March 20, 2025
- Indication:
- In Breast Implant Revision Surgery
Announcement
BD (Becton, Dickinson and Company) announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD's efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE™ Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery.
AI Summary
BD (Becton, Dickinson and Company) announced a major milestone in its quest for FDA Premarket Approval for its innovative use of the GalaFLEX LITE™ Scaffold. The company treated the first patient in an Investigational Device Exemption clinical trial designed to reduce the recurrence of capsular contracture—an often painful and displacing complication—after breast revision surgery. Capsular contracture, where scar tissue hardens around an implant, poses significant challenges and the trial aims to show how the absorbable GalaFLEX LITE™ Scaffold, made from Poly-4-Hydroxybutyrate (P4HB), can improve outcomes by providing strength and stability during healing. This early achievement marks an important step forward in clinical research, highlighting BD’s commitment to advancing biomaterial science and working closely with the FDA to offer safer, more effective options for patients undergoing breast revision procedures.
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