Archive for October 2019
CorFlow Therapeutics Gains “Breakthrough Device Designation” for CoFI™ (COF-fee) System
CorFlow Therapeutics AG announced that the FDA has designated the company’s CoFI (CorFlow Controlled Flow Infusion) System as a “Breakthrough Device” with a broad indication-for-use statement: “The CoFI™System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), and to be a platform for controlled infusion of therapeutic agents into the microcirculation with or without vessel occlusion.”…
Read MoreAuris Health’s Lung Cancer Detecting Robot has Late-Breaking Results from its First-in-Human Study
Auris Health, Inc., part of Johnson & Johnson Medical Devices Companies,* announced results from a study demonstrating the safety and feasibility of the Monarch Platform, a first-of-its-kind robotic technology indicated for use in diagnostic and therapeutic bronchoscopic procedures. Data from the BENEFIT study was presented in a late-breaking session at the CHEST 2019 Conference in New Orleans by Alexander…
Read MoreLess Radiation and High Resolution – Canon Medical gains FDA Clearance for AI Image Reconstruction Technology
Canon Medical Systems USA, Inc. has received 510(k) clearance on its Advanced Intelligent Clear-IQ Engine (AiCE) for the Aquilion PrecisionTM further expanding access to its new deep convolutional neural network (DCNN) image reconstruction technology. This technology, now available on both the Aquilion Precision and Aquilion ONE / GENESIS EditionTM premium CT systems, uses a deep learning algorithm to differentiate…
Read MoreA Better Night’s Sleep – ResMed Introduces AirFit N30, World’s First Tube-Down Nasal Cradle CPAP Mask
ResMed introduced AirFit N30, the world’s first tube-down nasal cradle CPAP mask with a front-facing tube – a brand-new option for sleep apnea treatment. ResMed’s lightest mask yet, AirFit N30 features an adjustable elastic headgear, plus a nasal cradle cushion that sits under the nasal bridge, eliminating soreness in that area. The mask’s curved cushion…
Read MoreNanomesh Drug Delivery Provides Hope Against Global Antibiotic Resistance
The fight against global antibiotic resistance has taken a major step forward with scientists discovering a concept for fabricating nanomeshes as an effective drug delivery system for antibiotics. Health experts are increasingly concerned about the rise in medication resistant bacteria. Flinders University researchers and collaborators in Japan have produced a nanomesh that is capable of…
Read MoreSynaptive Medical Partners with Stryker’s Advanced Guidance Technologies Business
Synaptive Medical and Stryker’s Advanced Guidance Technologies business (formerly known as Stryker’s Navigation business) announced a strategic partnership in surgical planning and surgical guidance. Through the partnership, Stryker will offer Synaptive’s BrightMatter™ Plan software, which automatically generates high-fidelity, dynamic, whole-brain tractography. Surgeons can easily review tracts and explore multiple surgical approaches to create powerful pre-operative plans—for every case.…
Read MoreADAM 3D Bone Printing Project Promises to Change How We Think About Our Bodies
ADAM, a 3D bone printing project that has already secured partnerships with ARMI, Stanley Black & Decker, and Big Pharma, is weeks away from launching the first clinical trials. But the project’s ambitions reach much further than simply creating bones. What differentiates ADAM from similar biotech projects is its innovations in speed and precision, as…
Read MoreMedtronic’s Tiny New InterStim Micro Neurostimulator Submitted to FDA
Medtronic announced it has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary…
Read MoreChip to Evaluate Health of Immune System from Blood Sample
Scientists from Nanyang Technological University, Singapore (NTU Singapore) have developed a lab-on-a-chip system that can identify the health aspects of a person’s immune system from a drop of their blood, within minutes. Using a combination of microfluidics – tiny microscopic channels that can isolate white blood cells from blood – and electrical sensors, the new chip was…
Read MoreFDA Clears geko Muscle Pump Activator to Prevent VTE
Sky Medical Technology Ltd, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its geko™ device for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE). This adds to Sky’s established 510k clearance for immediate post-surgical stimulation of calf muscles to prevent VTE, increasing blood circulation and…
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