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…

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Rapid 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…

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Samsara 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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Centerline Biomedical Raises $33 Million in Series B Financing

Centerline Biomedical, Inc. (Centerline), a private medical technology company, announced the closing of a $33 million Series B equity financing led by Cleveland Clinic with participation by GE Healthcare, RIK Enterprises, JobsOhio, Jumpstart Ventures and G2 Group Ventures. This funding will help propel the company into new surgical applications, accelerate its commercial sales and add to its…

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Lumendi Files for FDA 510(k) Clearance for Two New Products

Lumendi, LLC has announced it has filed for U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device intended for endoscopic mucosal resections (EMR) and difficult colonoscopies. The new design, based on the long-standing success of the DiLumen EZ-Glide platform, has been modified and streamlined. “This new device will…

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Article Reviews the Evolution of Arthroscopy from its Invention in 1912 to the Dawn of the Wireless ArthroFree™ Era

A recent history of arthroscopy by Dr. James S. Williams, Jr., and Dr. Asheesh Gupta reports that while there have been numerous incremental advances in arthroscopic camera technology over the last half-century, the current systems remain largely unchanged. Surgeons are tethered to the surgical tower by a power cable and by a light cord that…

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Limaca Medical Receives FDA Breakthrough Device Designation

Limaca Medical (“Limaca”) announced that its Precision-GI™ Endoscopic Ultrasound Biopsy Product has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”). The Precision-GI™ device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract. Endoscopic biopsy is performed by a gastroenterologist who accesses the targeted GI tumor utilizing an…

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Blackrock Neurotech Acquires Spatial Computing Software Firm MindX to Commercialize Full-Stack Brain-Computer Interface Product

Blackrock Neurotech, a leading implantable brain-computer interface (“BCI”) technology backed by world-renowned investors Peter Thiel and Christian Angermeyer, announced the acquisition of spatial computing software firm MindX, integrating the Company’s innovative augmented reality (“AR”) and artificial intelligence (“AI”) technology with Blackrock’s BCI hardware. MindX was created in 2017 by serial health-tech entrepreneur Julia Brown and Catalio Capital Management, a multi-strategy…

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TendoNova wins FDA Clearance for Its New Microinvasive Ocelot Surgical Tool

TendoNova, an emerging leader in microinvasive sports medicine procedures, is pleased to announce the FDA 510(k) clearance of its new Ocelot surgical tool, which uses an innovative technology for fragmentation or debridement of soft tissue. The FDA found the Ocelot TDS 1000 substantially equivalent to the Tenex TX1 (recently acquired by Trice Medical) which is…

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CoapTech to Initiate Clinical Trial for its PUMA-G Peds System for Pediatric Gastrostomy

CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced it has received an Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate a clinical trial for its PUMA-G Peds System, a device designed to provide a safer and more efficient way to place feeding tubes in…

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