FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy
NEWTON, Mass.--(BUSINESS WIRE) April 18, 2024 --Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the U.S. Food&... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 18, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Greenlights Imaging Agent to Detect Residual Cancer After Lumpectomy
(MedPage Today) -- The FDA approved pegulicianine (LumiSight) as an optical imaging agent for detecting residual cancer after breast-conserving surgery (BCS).
The approval stipulates use of pegulicianine with the Lumicell Direct Visualization... (Source: MedPage Today OB/GYN)
Source: MedPage Today OB/GYN - April 18, 2024 Category: OBGYN Source Type: news
Lumicell's Lumisight, LumiSytem get FDA nods
Lumicell's Lumisight (pegulicianine) optical imaging agent has been approved by a new drug application (NDA) by the U.S. Food and Drug Administration (FDA).
The FDA has also granted premarket approval for the company's LumiSystem, Lumicell's direct visualization system. Both Lumisight and LumiSystem previously received FDA Fast Track and Breakthrough Device designations.
LumiSystem allows surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries. Its combination with Lumisight is indi...
Source: AuntMinnie.com Headlines - April 18, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news
Cryoablation effective in women with breast cancer
A minimally invasive procedure called cryoablation that uses ice to freeze and destroy tumors has proven effective for women with large breast cancer tumors, according to a study presented March 27 at the Society of Interventional Radiology (SIR) meeting in Salt Lake City.
The finding suggests the technique may provide a new treatment path for women who are not candidates for lumpectomy, or surgical removal, noted Yolanda Bryce, MD, an interventional radiologist at Memorial Sloan Kettering Cancer Center in New York City, and senior author of the study.
“Surgery is still the best option for tumor removal, but there are ...
Source: AuntMinnie.com Headlines - March 27, 2024 Category: Radiology Authors: Will Morton Tags: Interventional Breast Source Type: news
Lumicell touts Lumisight clinical results
Lumicell highlighted clinical results presented at the recent Society of Surgical Oncology (SSO) in Atlanta, GA, that it says demonstrate the benefits of its Lumisight optical imaging agent for breast cancer.
In 2023, the company submitted a new drug application (NDA) for Lumisight for use in patients with breast cancer undergoing a lumpectomy, along with a premarket approval (PMA) application for its Direct Visualization System (DVS). On March 5, the U.S. Food and Drug Administration's (FDA) Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of Lumisight's benefit-risk profile, according to the firm. (S...
Source: AuntMinnie.com Headlines - March 25, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news
FDA Committee Gives New Cancer Surgery Tech a Positive Vote FDA Committee Gives New Cancer Surgery Tech a Positive Vote
Although most of the FDA ' s Medical Imaging Drugs Advisory Committee supported LUMISIGHT (pegulicianine), which aims to detect residual cancer during lumpectomy, some cite safety concerns.MDedge News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 11, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news
MIDAC gives the nod to Lumicell ’s Lumisight
The Medical Imaging Drugs Advisory Committee (MIDAC) has voted in support of the benefit-risk profile of Lumisight.
During a March 5 meeting, MIDAC members voted 16 to 2 in favor of the company’s recent new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its Lumisight optical imaging agent for breast cancer and a premarket approval application (PMA) for the company's direct visualization system.
The company’s combined product is an intracavity, fluorescence-guided surgical imaging tool used to detect residual cancer in real-time during lumpectomy surgery, also known as breast-conserving surg...
Source: AuntMinnie.com Headlines - March 7, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Breast Imaging Source Type: news
DBT surveillance screening after breast cancer treatment effective
Surveillance screening via digital breast tomosynthesis (DBT) immediately after breast cancer treatment is effective, a study published on December 20 in the American Journal of Roentgenology reported. Researchers led by Dan Do from Massachusetts General Hospital reported that while the abnormal interpretation rate was higher during the year after diagnosis compared to subsequent years, it remained at less than 10% in all years of their six-year study.“The results support the study institution’s protocol for patients with a prior breast cancer diagnosis of returning immediately to screening mammography with DBT and c...
Source: AuntMinnie.com Headlines - December 21, 2023 Category: Radiology Authors: Amerigo Allegretto Tags: Womens Imaging Subspecialties Breast Breast Imaging Source Type: news
Can Younger Postmenopausal Women With BC Skip Radiation? Can Younger Postmenopausal Women With BC Skip Radiation?
Women aged 65-70 years old are often offered the option of skipping radiation after lumpectomy for hormone receptor –positive early-stage breast cancer and moving straight to endocrine therapy.MDedge News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - December 8, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news
Is Omitting Radiation Therapy in Low-Risk Breast Cancer a Good IDEA?
(MedPage Today) -- SAN ANTONIO -- Postmenopausal women with genomically low-risk early hormone receptor (HR)-positive breast cancer had a low risk of recurrence with endocrine therapy alone after lumpectomy, a randomized trial showed.
The 5... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - December 8, 2023 Category: Hematology Source Type: news
The 12th Annual Breast Reconstruction Awareness Day USA returns Oct. 18 to Increase Recognition of Patient Options with Education, Events and Fundraisers
Patients deserve full and accurate information to empower them to make the best decisions for their bodies. Breast reconstruction is shown to improve patients' psychological, social and sexual well-being along with improving their quality of life following a mastectomy or lumpectomy.... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - October 18, 2023 Category: Pharmaceuticals Tags: WOM Source Type: news
Many high-risk women aren't getting appropriate breast cancer screening
Many women younger than 40 who are at high risk for breast cancer are not getting appropriate screening, according to findings published October 11 in the American Journal of Surgery. Researchers led by Christine Pestana, MD, from Wake Forest Baptist Health in Winston-Salem, NC, found that of the women younger than 40 in their study, only about 3% underwent appropriate screening despite over one in three meeting high-risk criteria. “This analysis highlights a significant discrepancy between those meeting criteria for high-risk screening and those who underwent appropriate screening,” the Pestana team wrote. Severa...
Source: AuntMinnie.com Headlines - October 12, 2023 Category: Radiology Authors: Amerigo Allegretto Tags: Womens Imaging Breast Source Type: news
Fluorescent Guide Can ID Tumor Missed by Standard Lumpectomy
TUESDAY, May 23, 2023 -- For patients with stages 0 to 3 breast cancers, pegulicianine fluorescence-guided surgery (pFGS) can enhance the efficacy of lumpectomy surgery, according to a study published online April 27 in NEJM Evidence.
Barbara L.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 23, 2023 Category: Pharmaceuticals Source Type: news
Key Takeaways in Early Breast Cancer From AACR 2023 Key Takeaways in Early Breast Cancer From AACR 2023
A novel agent used to visualize positive margins in lumpectomy, the effect of race on skin toxicity in radiotherapy, and DCIS recurrence are key highlights from AACR 2023, reported by Dr Kathy Miller.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 4, 2023 Category: Consumer Health News Tags: None ReCAP Source Type: news
Novel Fluorescence Guidance Improves Lumpectomy Outcomes Novel Fluorescence Guidance Improves Lumpectomy Outcomes
Intracavity, real-time assessment of margins using a novel imaging agent and visualization system may improve complete resection rates, new findings show.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 4, 2023 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
