• Carl Zeiss (Jena, Germany) made presentations on optical coherence tomography (OCT) angiography at this year's Association for Research in Vision and Ophthalmology (ARVO) meeting. One study compared OCT angiography (using a prototype based on the CIRRUS HD-OCT 5000) with fluorescein angiography (FA) imaging in a subject who had diabetic retinopathy. There was a clear correlation between the OCT angiography and fluorescein images, plus OCT angiography was found to reveal much clearer microvascular details. OCT angiography also provided depth resolved information that was not available with FA.

• Cohera Medical (Pittsburgh), a maker of absorbable surgical adhesives and sealants, said its Sylys surgical sealant has received Expedited Access Pathway (EAP) designation and priority processing status from the FDA. Sylys is a resorbable synthetic sealant designed to help reduce anastomotic leakage in gastrointestinal procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur. The FDA has designated Sylys Surgical Sealant as an Expedited Access Pathway device due to its potential to address the unmet need related to gastrointestinal leaks.

• Luminex (Austin, Texas) has commenced clinical and analytical studies to evaluate the company's ARIES Group B Streptococcus (GBS) Assay. Clinical trials for the ARIES GBS Assay are being conducted at several labs in the U.S., and Luminex still expects its FDA submission for the ARIES platform and ARIES HSV 1&2 Assay to occur this summer. ARIES uses internal barcode scanning and other features to minimize operator errors. Two independent magazine modules support from one to six cassettes each, allowing for STAT and Batch testing.

• Medtronic (Dublin) has offered the GastriSail gastric positioning system to help promote more consistent sleeve creation and greater procedural efficiency within the sleeve gastrectomy procedure. Developed by Medtronic's Minimally Invasive Therapies Group, the GastriSail system combines the benefits of three devices into one, allowing surgeons to consistently size and decompress the stomach pouch and test for leaks without removing and reinserting another device. With fewer device insertions, there is potentially less risk of irritating or injuring the esophagus during the procedure. During a sleeve gastrectomy procedure, surgeons use minimally invasive approaches to remove approximately two-thirds of the stomach to create a small sleeve-shaped pouch.

• Stimwave Technologies (Miami) has received FDA investigational device exemption (IDE) approval to launch an 80-patient clinical trial using its wireless miniature eight electrode, multi-programmable neurostimulator device for the relief of chronic back and leg pain. The Stimwave Freedom Spinal Cord Stimulation (SCS) System is the smallest neuromodulation device ever commercialized, according to the company. It is available in an eight-electrode array, which provides additional programming and placement options for patients, including the use of high-frequency stimulation. The FDA also approved Stimwave's high frequency study using an external pulse generator. The experiment, needed for IDE approval, will compare conventional stimulation programming settings of five to 1,500 Hz frequencies to those of a higher 10,000 Hz frequency to measure pain relief outcomes, patient preferences, reduction in opioid usage, and reduction in adverse events, compared with conventional internal pulse generator products.

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