Medrobotics wins FDA 510(k) for transoral surgery device

Medrobotics said today it won FDA 510(k) clearance for its Flex robotic transoral surgery system and is launching the system in the U.S. The Flex system uses a flexible robotic endoscope, a range of flexible instruments and a high-definition vision system for use in accessing and visualizing structures in the mouth and throat, Raynham, Mass.-based Medrobotics said. “The Flex robotic system is the 1st and only robot-assisted surgical platform with a flexible scope cleared by FDA for use during transoral procedures. The minimally invasive system enables surgical access and visualization in hard-to-reach locations through a single site. Doctors can then complete procedures that might otherwise be difficult, or even impossible, to perform due to inability to visualize or access the site,” CEO Samuel Straface said in a prepared statement. “The Flex Robotic System provides unparalleled access and visualization of the oropharynx, hypopharynx and larynx. When used in combination with the highly adjustable Flex retractor, surgeons can greatly extend their reach in challenging areas of the mouth and throat. I consider these products transformative,” Medrobotics medical advisory board co-chair Dr. Marshall Stromeof the Cleveland Clinic Head and Neck Institute said in a press release. After the operating physician positions the robotic scope at the necessary vantage point, the scope can become rigid to provide a more stable operating platform for th...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Robot-Assisted Surgery Surgical Medrobotics Source Type: news

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Conditions:   Clinical Stage III Human Papillomavirus (HPV)-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8;   Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8;   Locally Advanced Head and Neck Squamous Cell Carcinoma;   Locally Advanced Hypopharyngeal Squamous Cell Car cinoma;   Locally Advanced Laryngeal Squamous Cell Carcinoma;   Locally Advanced Oral Cavity Squamous Cell Carcinoma;   Locally Advanced Oropharyngeal Squamous Cell Carcinoma;   Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8;   Pathologic Stag...
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
ConclusionsSurveillance by gastrointestinal endoscopy every 6  months and surveillance by an otolaryngologist every 12 months could detect second primary head and neck cancers at an early stage, thereby facilitating minimally invasive treatment.
Source: Japanese Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
Conditions:   p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma;   Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7;   Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7;   Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7;   Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7;   Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7;   Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7;   Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7;   Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7;   Stage IVA Hypopharyngeal Squ...
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Abstract Head and neck cancer (HNC), which includes epithelial malignancies of the upper aerodigestive tract (oral cavity, oropharynx, pharynx, hypopharynx, larynx, and thyroid), are slowly but consistently increasing, while the overall survival rate remains unsatisfactory. Because of the multifunctional anatomical intricacies of the head and neck, disease progression and therapy-related side effects often severely affect the patient's appearance and self-image, as well as their ability to breathe, speak, and swallow. Patients with HNC require a multidisciplinary approach involving surgery, radiation therapy, and ...
Source: Biomedicine and pharmacotherapy = Biomedecine and pharmacotherapie - Category: Drugs & Pharmacology Authors: Tags: Biomed Pharmacother Source Type: research
AbstractPurposeOur aim is to determine the impact of the size of ROI in detecting subcentimeter metastatic lymph nodes in patients with head and neck squamous cell carcinoma (HNSCC). Secondary aim is to determine the impact of the histopathologic grade of the primary cancer on the ADC value of the metastatic nodes.MethodsThe prospective study included 51 patients with histopathologically proven HNSCC at the primary site. Primary site includes oral cavity, oropharynx, larynx, and hypopharynx. ADC values of the lymph nodes were measured on ADC maps by placing two ROIs in the lymph nodes (0.2 cm2 in the center of the node and...
Source: Neuroradiology - Category: Radiology Source Type: research
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