Search Results for “surgical” – Page 21 – media

Abbisko Therapeutics Announces that U.S. FDA Has Granted Fast Track Designation for Its CSF-1R Inhibitor Pimicotinib(ABSK021)

Abbisko Therapeutics Co., Ltd.(Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib(ABSK021) has been granted the fast track designation (FTD) by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. Previously, pimicotinib was granted the breakthrough therapy designation (BTD) by the U.S. FDAfor TGCT in January, 2023.The grant of FTD and BTD will accelerate the global development and commercialization of pimicotinib. Fast Track is a policy designed to facilitate the development and expedite the review of drugs in order to treat serious conditions and fulfill unmet medical needs. Its purpose is to get important new drugs to patients earlier. Moreover, the FTD enables companies to maintain more frequent communications and meetings with the U.S.FDA. The drug also becomes eligible for accelerated approval and priority review by the U.S.FDA. In early December, Abbisko entered into an agreement with Merck KGaA, Darmstadt, ...
- Source: drugdu
- 104
- December 17, 2023
HPV DNA Test Using Lymphatic Fluid Collected After Surgery Could Predict Risk of Cancer Recurrence

Head and neck cancer, previously linked to heavy drinking and smoking, has seen a significant shift due to human papillomavirus (HPV). In fact, HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) has become the most prevalent HPV-related cancer, surpassing cervical cancer, with increasing cases globally. Despite treatments, up to 30% of head and neck cancer patients face recurrences, often due to elusive cancer cells that treatments miss. Recently, the focus has shifted to liquid biopsy for detecting cancer recurrences post-treatment. Liquid biopsies search for cancer indicators in body fluids like blood and urine. Now, a new study has found that liquid biopsy of lymphatic fluid, which is commonly thrown away post-surgery, could be key in tailoring treatments for HPV-driven head and neck cancer. The groundbreaking study by researchers at University of Pittsburgh (Pittsburgh, PA, USA) and Washington University School of Medicine in St. Louis (WUSTL, St. Louis, MO, USA) revealed that HPV ...
- Source: drugdu
- 104
- December 14, 2023
Nanopore Sequencing Cuts Tumor Analysis Times and Costs, Finds Study

Copy number variations (CNVs), which activate oncogenes and inactivate tumor suppressor genes, play a crucial role in the development and progression of cancers. As such, CNV analysis is a vital component of tumor grading and diagnosis. Traditionally, this analysis relies on nucleotide hybridization and next-generation sequencing, methods confined to high-complexity centralized laboratories and requiring several days to complete. A more rapid, cost-effective, and straightforward approach to CNV analysis could significantly enhance clinical decision-making, refine surgical planning, and facilitate the identification of potential molecular therapies within the timeframe of surgical procedures. Researchers have now identified nanopore sequencing as a method to refine CNV analysis. A study conducted by researchers at Dartmouth-Hitchcock Medical Center (DHMC, Lebanon, NH, USA) has found nanopore sequencing to be a more efficient means for CNV analysis. They used Oxford Nanopore’s MinION device, which offers real-time interpretation of long-read nucleotide sequences. To adapt this technology for CNV detection, ...
- Source: drugdu
- 102
- December 13, 2023
Merck and Moderna to Launch Trial of mRNA-4157 Plus Keytruda in Non-Small Cell Lung Cancer

Pharmaceutical Executive Editorial Staff Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer. Image credit: Axel Kock | stock.adobe.com Merck and Moderna, Inc., have announced plans to launch the pivotal Phase III INTerpath-002 (NCT06077760) clinical trial of the novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). V940 is comprised of synthetic mRNA coding for up to 34 neoantigens that are designed and produced based on the unique mutational signature of a patient’s tumor. After administration of the drug, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation. “As lung cancer is the leading cause ...
- Source: drugdu
- 100
- December 13, 2023
Edwards plans to spin off critical care business next year

BY SEAN WHOOLEY Edwards Lifesciences (NYSE: EW)+ announced today that it intends to spin off its critical care business by the end of 2024. The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart monitoring technologies next year. “During 2024, Edwards plans to support the growth and leadership of innovations in advanced patient monitoring, with the goal of improving the quality of care for millions of patients annually,” Edwards wrote in a news release. Analysts expect shares of Edwards to move up on the news today. Shares of EW rose 1% at $70.17 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remained even. Edwards intends to complete the spin-off tax-free. The ...
- Source: drugdu
- 103
- December 11, 2023
Microbot Medical is a step closer to an FDA IDE submission

BY CHRIS NEWMARKER Microbot Medical today announced the successful completion of its pivotal pre-clinical study of its Liberty endovascular robotic surgical system. The study, performed under good laboratory practice (GLP) and essential for the company’s investigational device exemption (IDE) submission, took place under rigorous FDA guidelines. The study involved pigs. In this study, three interventional radiologists performed 96 robotic navigations using Liberty. They used the system to control various commercially available intravascular catheterization devices. They then microscopically examined and evaluated the target vessels and surrounding tissue. Microbot Medical officials think Liberty’s remote operation could enable it to democratize endovascular interventional procedures. “I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” said Juan Diaz Cartelle, chief medical officer of Braintree, Massachusetts–based Microbot Medical. “This gives us confidence to move forward to the next stage of human clinical study.” Microbot Medical CEO ...
- Source: drugdu
- 110
- December 9, 2023
Intuitive’s venture capital arm launches second investment fund

Dive Brief Intuitive Surgical’s venture capital arm has launched a second investment fund with $150 million in new capital. The Intuitive Ventures fund will support startups focused on improving healthcare access and coordination, developing precision diagnostics and interventions, and integrating digital technology, the firm said Monday. The new fund follows the launch of Intuitive’s first venture capital fund three years ago and brings the firm’s total assets under management to $250 million. Dive Insight The robotic surgery leader is among a number of large medtech companies to establish a venture capital operation dedicated to supporting a portfolio of early-stage companies. GE HealthCare, Johnson & Johnson and Boston Scientific have also launched venture funds. The venture has since invested in more than 10 startups, supported by Intuitive Surgical’s network and corporate oversight. Those companies include Capstan Medical, Endogenex, Flywheel, KelaHealth, MedCrypt, Neocis Optellum and Surge Therapeutics. “Fund II deepens Intuitive’s commitment ...
- Source: drugdu
- 111
- December 7, 2023
Exactech wins clearance for new ankle surgery navigation system

BY CHRIS NEWMARKER ExactechGPS Ankle [Image courtesy of Exactech]Exactech announced today that its BlueOrtho subsidiary has received FDA 510(k) clearance for ExactechGPS Ankle. The Gainesville, Florida–based company described the system as the first of its kind for total ankle arthroplasty. It connects the preoperative plan with real-time intraoperative instrument guidance, confirming that resections meet the surgical plan. Designed to improve surgical precision, the ExactechGPS Ankle combines propriety active tracker technology with a touchscreen tablet, providing dynamic feedback to surgeons during procedures. “I am already a fan of Exactech’s patient-specific instrumentation solution and am thrilled how GPS Ankle provides intraoperative flexibility at my fingertips. The ability to quantify soft tissue laxity will be a game changer for me and my patients,” said design team surgeon Dr. Edward Haupt of the Mayo Clinic in Florida. GPS Ankle has compatibility with Exactech’s flagship Vantage Total Ankle System. It will be available to hospitals ...
- Source: drugdu
- 108
- December 7, 2023
【EXPERT Q&A】What are the differences between the MDR and IVDR regulations?

Drugdu.com expert’s response: Although the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) share a common purpose, they apply to different categories of products, with specific differences in the following aspects: Scope of Application: MDR is a regulation for medical devices: It applies to all medical devices not used for in vitro diagnostics, including surgical tools, medical equipment, implants, etc. IVDR is a regulation for in vitro diagnostic medical devices: It specifically applies to in vitro diagnostic devices, such as reagent kits and equipment used for blood analysis. Classification System: MDR: Implements a new risk-based classification system, detailing medical devices into different levels more comprehensively. IVDR: Introduces a new risk classification rule, which is a significant change for the in vitro diagnostic device industry, especially increasing the scrutiny requirements for high-risk IVD products. Clinical Requirements: MDR: Strengthens the requirements for clinical evidence, demanding manufacturers to conduct clinical assessments and ...
- Source: drugdu
- 195
- December 4, 2023
Medtronic to chase Boston Scientific, Abbott in left atrial appendage closure market

Dive Brief Medtronic said Monday it is launching a device in the U.S. designed to close the left atrial appendage (LAA) of the heart in patients undergoing cardiac surgery. The treatment is intended for patients who have atrial fibrillation (AFib), an arrhythmia that can lead to stroke. The introduction of the implantable LAA clip, called Penditure, marks Medtronic’s entry into the fast-growing market for left atrial appendage closure devices, led by Boston Scientific’s Watchman franchise. Medtronic said it acquired the LAA exclusion system in August from Miami-based medical device incubator Syntheon, in a move to expand its cardiac surgery portfolio. Terms of the transaction were not disclosed. Dive Insight Medtronic’s device is the newest challenger to Boston Scientific’s Watchman in a growing market that includes Abbott’s Amplatzer Amulet treatment, which gained approval from the Food and Drug Administration in 2021, and AtriCure, whose AtriClip device was the first LAA exclusion ...
- Source: drugdu
- 176
- November 30, 2023

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