Heather Thompson, MDO senior editor CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for […]
510(k)
Cerêve lands $38m Series B for insomnia device
Cerêve Inc., said today that it closed a$38 million Series B found, led by global investment firm KKR. Other investors included Versant Ventures, Arboretum Ventures and Partner Ventures. The company is gearing up to launch its Cerêve Sleep System device, which is designed to reduce latency to stage 1 and stage 2 sleep for patients […]
Precision Spine wins FDA 510(k) for AccuFit lateral plate system
Precision Spine said today it won FDA 510(k) clearance for its AccuFit lateral plating system designed to treat spinal instability. The Parsippany, N.J.-based company’s AccuFit lateral plate system consists of non-sterile, single use rigid plates designed to attach to the lateral portions of the vertebral body of the thoracolumbar spine with bone screws. “As a system that […]
Nephros wins 510(k) for HydraGuard bacterial water filter
Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its water ionizer review designed for water bacterial filtration. The River Edge, N.J.-based company said its HydraGuard 10″ UltraFilter is designed to provide 6 months of bacterial protection and filtration for potable water sources such as endoscope re-processors, surgical humidifiers and ice machines. “The HydraGuard is a […]
FDA expands clearance for Avinger’s Lightbox L250 vascular imaging console
Avinger (NSDQ:AVGR) said today that it won 510(k) clearance from the FDA for its Lightbox L250 imaging console. The software is designed to improve visualization inside vessels before, during and after Pantheris Lumivascular atherectomy procedures in patients with peripheral artery disease. “The ability to obtain an accurate and real-time measurement from inside a diseased vessel is […]
Changing your medical device: What you need to know
When it comes to changing a medical device, one of the most important decisions can involve whether to log it in as an internal letter-to-file or submit a special 510(k) or PMA supplement with FDA. In many cases, company officials don’t do some initial investigation before making the decision, according to Vascular Sciences President Michael Drues, who has […]
FDA denies Milestone Scientific’s Compu-Flo 510(k) application
Milestone Scientific‘s (OTC:MLSS) said today that the FDA denied the 510(k) application for its Compu-Flo intra-articular computer controlled injection system due to inadequate documentation showing that the device met required equivalency standards. The Livingston, N.J.-based company said that after meeting with the FDA’s Office of Device Evaluation, it plans to provide additional data, including a new […]
Clarius wins FDA 510(k) for wireless ultrasound device
Mobile ultrasound developer Clarius Mobile Health said today it won FDA 510(k) clearance for its C3 and L7 Clarius wireless ultrasound scanners. Clarius’ C3 multipurpose ultrasound scanner is designed to image the abdomen and lungs, with an incorporated virtual phased array for heart scans, while the L7 is designed for guiding procedures and imaging superficial […]
Lumendi wins FDA 510(k) for DiLumen endoscope positioning accessory
Medical device developer Lumendi said today it won FDA 510(k) clearance for its DiLumen endoscopic accessory. The Connecticut-based company’s DiLumen device is now indicated for use in positioning endoscopes in Treatments for IBS and assisting with optical visualization, diagnosis and endoscopic treatment. This most often occurs when the colon can’t pass or move stools through […]
FDA releases November 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD November 2016 TOTAL 510(k)s THIS PERIOD 254 TOTAL WITH SUMMARIES 241 TOTAL WITH STATEMENTS 13 DEVICE: Quest Diagnostics HairCheck-DT (Cocaine) Quest Diagnostics Incorporated 510(k) NO: K152232(Traditional) ATTN: Lisa Christo PHONE NO : 913 5771784 10101 Renner Blvd. SE DECISION MADE: 18-NOV-16 Lenexa KS […]
One Drop wins FDA nod, CE Mark for mobile blood glucose monitor
One Drop said today that it won 510(k) clearance from the FDA and CE Mark clearance for its One Drop | Chrome blood glucose monitoring system. The system is a part of One Drop | Premium, which the company touts as the 1st-ever monthly subscription service for affordable diabetes care. The subscription service includes unlimited blood glucose testing […]