Posts by rw-admin
ClearPoint Neuro Announces FDA Clearance for ClearPoint Maestro™ Brain Model
ClearPoint Neuro, Inc., a global therapy-enabling platform company providing navigation and delivery to the brain, announced it has received 510(k) clearance for its ClearPoint Maestro™ Brain00 Model. Maestro is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. This software is intended to automate the…
Read MoreOSSIO Announces U.S. Launch and First Commercial Use of OSSIOfiber® Suture Anchors
OSSIO, Inc., a fast-growing orthopedic fixation technology company, announced the U.S. launch and first commercial use of OSSIOfiber® Suture Anchors, expanding patient access to the company’s growing portfolio of bio-integrative implants for use in foot/ankle, shoulder, knee, hand/wrist and elbow surgery. Gregory Berlet, M.D., founding partner at Orthopedic Foot and Ankle Center in Columbus, Ohio, recently…
Read MoreMicroPort Navibot Receives 510(K) Clearance for its SkyWalker™ Robot-Assisted Platform for Orthopedic Applications
MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker™ System, the company’s first robot-assisted platform for orthopedic applications. The SkyWalker™ System will initially offer a robotically assisted total knee replacement solution that is compatible with the Evolution® Medial-Pivot Total Knee System. Designed based on clinical needs, MicroPort…
Read MoreSpineology® Launches First Fully Endoscopic, Single-Tubular Retractor Fusion System: OptiLIF® Endo
Spineology Inc., the longtime leader in ultra-minimally invasive spine surgery, announces another milestone with the limited launch of OptiLIF® Endo. This innovative, ultra-MIS system requires only one tubular retractor to seamlessly integrate endoscopes and endoscopic equipment into lumbar interbody fusion procedures. The OptiMesh® Multiplanar Expandable Implant enables this single tube system to employ the smallest diameter tubular retractor of…
Read MoreCognito Therapeutics Announces Proprietary Gamma Sensory Stimulation for 6-Months Reduces White Matter Atrophy in Alzheimer’s Disease Patients
Cognito Therapeutics, announced that its proprietary gamma sensory stimulation at 40Hz over a 6-month period reduced white matter atrophy in the brain for patients with Alzheimer’s Disease, according to new data presented at the Alzheimer’s Association International Conference 2022. Alzheimer’s Disease (AD) is the most common form of dementia. Although white matter atrophy is observed…
Read MoreRapid Medical Gains FDA Clearance for the Smallest & Only Adjustable Thrombectomy Device
Rapid Medical, a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. TIGERTRIEVER 13 is the smallest revascularization device in the world to date and is designed to remove thrombus from delicate brain blood vessels during an…
Read MoreCaption Health Receives CE Mark for Caption AI™ Technology Platform
Caption Health, the leader in using AI and services to improve heart ultrasound access, announced that it has received a CE Mark for its Caption AI™ technology platform. This certification represents the first step in making Caption Health’s industry-leading technology platform available outside the US, and highlights the company’s strong clinical and regulatory track record…
Read MoreHow and Why Your Resume Should be for TWO different audiences: Man and Machine
Resume writing advice is everywhere online. There are guides that proudly proclaim how important resume titles are, or how your Times New Roman font is preventing you from finding your next job, to guides that insist you use a professional service to “set yours apart from the rest.” The popular conception is that there’s stack…
Read MoreAncora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System
Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch® Ventricular Restoration System. Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the AccuCinch System is designed to provide a minimally invasive treatment option for…
Read MoreSamsara Vision Announces First U.S. Surgeries of the SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope), for Age-Related Macular Degeneration as part of the CONCERTO Study
Samsara Vision, a company focused on bringing vision and freedom back to patients with late-stage, age-related macular degeneration (AMD) through advanced visual prosthetic devices, announced the completion of the first U.S. surgeries of its SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope), as part of the CONCERTO clinical study, a U.S.-based Food and Drug Administration (FDA)…
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