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From AI-Based IVDs To Precision Drug Dosing: Medtech Conference 2017 Gives Insight Into Tomorrow's Technologies
The annual AdvaMed conference, rebranded "Medtech Conference" this year, drew more than 2,700 attendees seeking to explore cutting-edge technologies and networking opportunities, as well as to hear from FDA's top officials about new developments. This article takes a closer look at some of the most innovative solutions presented at the event, including machine learning-based diagnostics to combat antimicrobial resistance, a ureter-locating device, virtual reality technologies to enhance orthopedic surgery and precision drug dosing, among other things.
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DenerveX is a unique surgical tool used to ablate the nerve and capsular tissue on the posterior surface of the facet joint. preventing the nerve from reattaching with the goal of creating lasting relief from back pain that otherwise might require spinal fusion and/or treatment with opiate drugs.
With its coffers topped up and a new CEO in place, Lumicell is forging ahead with clinical trials of its LUM real-time, cancer imaging system, designed to improve the outcomes of surgical resection of tumors. The company's first target indication is for breast cancer and it is aiming for a US premarket approval in late Q1 of 2019.
US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.
Having secured Medicare reimbursement, Seattle, Washington-based Indi Diagnostics, Inc. is getting ready to bring its liquid biopsy molecular test to pulmonologists in the US starting Q1 2018. The company said it will be first to introduce a liquid biopsy molecular diagnostic test in the country designed to help pulmonologists identify lung nodules that have a high probability of being benign, saving patients unnecessary invasive procedures.
OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks; iVascular Earns Five Approvals In India
Cardiovascular and diabetes device dominated September's list of medical device approvals from outside the US on Medtech Insight's Approvals Tracker. The 24 non-US approvals in September is below average for 2017, but one more than September of 2016 and keeps 2017 on a track to have about 40% more non-US approvals than 2016.
The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.
Start-Up Spotlight: Arkis BioSciences, Endexo-Boosted Ventricular Drainage Catheter Reduces Obstructions
Arkis BioSciences Inc.'s newly launched CerebroFlo EVD catheter for treating intracranial hypertension offers an added benefit of being impregnated with Endexo, an antiocclusive agent that in laboratory studies has shown to dramatically reduce the incidence of thrombus formation, which can potentially reduce catheter obstructions.
The company's SpaceOAR injected hydrogel spacer continues to prove effective at reducing the collateral damage from radiation treatment for prostate cancer. Now the Boston company hopes to apply the same bioabsorbable hydrogel technology to improve outcomes with radiation therapy for other cancers, including pancreatic and gynecological cancer.
Israeli start-up Augmedics is developing an augmented reality vision system designed to give surgeons "X-ray vision." The company's ViZOR system uses see-through AR optics to project a 3D image of a patient's spine onto a surgeon's retina, in real-time.
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