Profile: Spectrascience, Inc. develops a technology platform to instantly determine if tissue is normal, pre-cancerous or cancerous, without the need for exploratory biopsy. The system is indicated for use as an adjunct to lower gastrointestinal endoscopy and is intended for the evaluation of polyps less than 1 cm in diameter,that the physician has not already elected to remove. The device is used in deciding which polyps should be removed and submitted for histological examination. Our Wavstat® optical biopsy system is capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body and without waiting days for a pathology report. It uses a spectrophotometry technique known as laser induced fluorescence. Our LUMA Cervical imaging system is a safe and effective method,that when used as an adjunct to colposcopy,will find at least 26% more high-grade pre-cancerous disease than the gold standard colposcopy in women with ASC & LSIL Pap tests.
11 Products/Services (Click for related suppliers)
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• Cervical Imaging Systems |
• Electro-Optical(For Cervical Cancer) Sensor (FDA Code: MWM) |
• Fiberoptic Diagnostic Analyzer (FDA Code: MOA) |
• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• Optical Biopsy System Consoles |
• Percutaneous Catheter (FDA Code: DQY / 870.1250) A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. |
• Percutaneous Catheters Sets, Pediatric |
• Percutaneous Catheters Sets, Pediatric Percutaneous Access |
• Peripheral Angioplasty Laser (FDA Code: LWX) |
• Urological Percutaneous Catheters and Sets |
• Xenon Arc Endoscope Light Source (FDA Code: GCT / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |