Marcus Engineering, LLC

?? Congratulations to the following companies for securing 510(k) clearance this week: KOROT Co. Ltd. has received clearance for the Korot P3 Accurate, an innovative blood pressure monitor that automates the detection of Korotkoff sounds to provide precise readings. This marks their first 510(k) submission. Monogram Technologies. has been granted clearance for the mB?s TKA System, a robotic-assisted total knee arthroplasty system designed to enhance surgical accuracy and patient outcomes. This is also their first 510(k) submission. Samsung NeuroLogica has obtained clearance for the BodyTom 64, an advanced portable CT scanner that offers enhanced imaging capabilities for diverse clinical settings. These advancements demonstrate the ongoing innovation in medical technology, promising improved healthcare solutions for patients worldwide.

This week, several innovative medical devices received their 510(k) clearances. Here are some highlights: Shanghai Longmann Tech Co., Ltd. achieved clearance for the Cufftrek, marking their first submission. While the company's past activities have primarily involved manufacturing components like compressors and heat exchangers, this clearance represents their entry into the medical device sector. EpiWatch, Inc. received clearance for the EpiWatch Monitoring System, also marking their first submission. This system utilizes wearable technology to monitor physiological signals associated with seizures, aiming to enhance epilepsy management. Fort Defiance Industries (FDI) secured clearance for the Front-Line Field Sterilizer (FL135). This device is designed to provide sterilization capabilities in field settings, supporting medical operations in challenging environments. ? Congratulations to these companies for their advancements in medical technology!

This week, the FDA granted several noteworthy 510(k) clearances: Google/Fitbit (now part of Google) this week the granted 510(k) clearance to Google's Pixel Watch 3 for its Loss of Pulse Detection tecnology. This feature can detect the absence of a pulse and, if the wearer is unresponsive, automatically contact emergency services. Xaga Surgical achieved their inaugural 510(k) clearance for the Forsvall Biopsy Needle System, engineered to reduce bacterial transfer during prostate biopsies by over 96%, thereby minimizing infection risks and enhancing diagnostic accuracy. Promethean Restorative secured clearance for the Dynamis? SI Screw System, a novel solution in sacroiliac joint fixation, reflecting their dedication to improving orthopedic surgical outcomes. Big congratulations to these companies for their significant contributions to medical innovation! ????

This week, several companies have achieved significant milestones with their recent 510(k) clearances: Visby Medical received clearance for their Visby Medical Respiratory Health Test, a portable PCR device delivering rapid and reliable respiratory infection diagnostics at the point of care. Compumedics Limited - Official Limited introduced the Falcon HST, an advanced home sleep testing device designed to enhance the diagnosis of sleep disorders through comprehensive and user-friendly monitoring. Stryker Neurovascular launched the AXS Lift Intracranial Base Catheter, a device engineered to provide improved access and support during neurovascular procedures, thereby advancing treatment options for complex cerebrovascular conditions. These innovations reflect the ongoing commitment to enhancing patient care and expanding the capabilities of medical technology.

This week, several innovative medical devices have achieved 510(k) clearance, marking significant advancements in healthcare technology. ?? Here are some highlights: LimFlow V-Ceiver by LimFlow Inc.: Designed to assist in complex vascular procedures, the LimFlow V-Ceiver is a specialized device intended for snaring specific 0.014” guidewires, enhancing precision in interventional techniques. limflow.com WARD-CSS (V1.2.X) by Ward 24/7 ApS: This marks the company's first 510(k) clearance. The WARD Clinical Support System (WARD-CSS) offers continuous 24/7 monitoring of vital signs in general wards, utilizing advanced algorithms to detect patient deterioration early and improve clinical outcomes. Integrated Endo System (Meet Endo-II) by DENJOY DENTAL CO,LTD Dental Co., Ltd.: Another first-time 510(k) recipient, Denjoy introduces the Meet Endo-II, an all-in-one endodontic system featuring a high-capacity battery and a 7-inch capacitive touch screen, streamlining dental procedures with enhanced efficiency. These developments reflect the ongoing commitment to innovation in the medical device industry, aiming to improve patient care and clinical outcomes.

Congratulations to the following companies for achieving 510(k) clearance this week: PranaQ Pte. Ltd. has received clearance for TipTraq, a lightweight, fingertip-worn device designed for at-home sleep apnea screening and monitoring. This innovative wearable utilizes AI algorithms to analyze respiratory and cardiac signals, providing users with comprehensive sleep health insights. PranaQ.com Medical Microinstruments, Inc. has secured clearance for the Symani Surgical System, a groundbreaking robotic platform engineered to enhance precision in microsurgical procedures. Featuring the world's smallest wristed instruments, Symani offers motion scaling and tremor reduction technologies, expanding the possibilities in delicate surgical interventions. MMI - Medical Microinstruments, Inc. CytoChip Inc. has obtained clearance for the Cito CBC System, a point-of-care hematology analyzer that delivers complete blood count results within minutes from a single drop of blood. This advancement aims to make diagnostic testing more accessible and efficient across various healthcare settings. CYTOCHIP INC.com ?? Notably, PranaQ Pte. Ltd. and CYTOCHIP INC. are first-time submitters, marking significant milestones in their contributions to medical technology.

Congratulations to EssilorLuxottica for receiving FDA clearance for their Nuance Audio glasses, seamlessly integrating prescription eyewear with hearing solutions to assist those with mild to moderate hearing loss. reuters.com Kudos to Gentuity, LLC for securing 510(k) clearance for their HF-OCT Imaging System, featuring the world's smallest imaging catheter, enhancing pre- and post-coronary intervention imaging. biospace.com Applause to Shenzhen Zhongkemingwang Telecommunications Software Corp. for obtaining their first 510(k) clearance for the Wrist Blood Pressure Monitor (OHMS11, OHMS12), contributing to accessible cardiovascular health monitoring.

?? Marcus Engineering’s Weekly 510(k) Roundup Here’s a closer look at some standout 510(k) clearances granted this week: 1?? Cyncronus LLC ?? Congratulations to Cyncronus LLC for receiving their first-ever 510(k) clearance for CephNinja! This innovative device brings advanced cephalometric imaging technology to orthodontics and dentistry. An exciting debut for this emerging company! 2?? Hathor Professional Skincare Ltd. ?? Hathor Professional Skincare secures their first 510(k) clearance for the Sutil Luxe Personal Lubricant line. These formulations aim to enhance comfort and care in women’s health. Great to see new players advancing innovation in personal wellness! 3?? Ibex Medical Analytics Ltd. ?? Kudos to Ibex Medical Analytics for their first clearance for Galen? Second Read?, an AI-powered pathology solution. This technology assists in detecting cancerous findings in pathology slides, paving the way for more efficient diagnostics. Congratulations to all companies advancing healthcare with their latest innovations! #MedicalDevices #510kClearance #HealthcareInnovation #MedTech

?? Marcus Engineering's Weekly 510(k) Roundup – Week of January 20, 2025 ?? Congratulations to all companies receiving 510(k) clearance this week! Here are three standout approvals: 1. Navi Medical Technologies – ?? First-time submitter! Navi Medical's NeoNav ECG Tip Location System secured clearance under Cardiovascular. This innovative system assists in precise catheter placement, enhancing neonatal care. 2. Prenuvo – ?? Also a first-time submitter! Their Body Composition imaging system, cleared in Radiology, offers advanced whole-body MRI insights with a focus on preventive healthcare. 3. Shenzhen Superline Technology Co., Ltd. – ?? Yet another first-time clearance! Their Alpha Apex I, an electronic apex locator for dental applications, brings enhanced precision to root canal treatments. Marcus Engineering proudly supports the growth of groundbreaking medical technologies. ?? Let's keep pushing boundaries in 2025! #MedicalDevices #510k #Innovation #RegulatoryApproval

Big congratulations to Shenzhen Ruiankang Technology Co., Ltd. for securing their first 510(k) clearance for the Blood Pressure Monitor (RAK260 series). This achievement marks a significant milestone for the company, known for its expertise in manufacturing health monitoring devices such as infrared thermometers and compression atomizers. Kudos to Solo Pace inc. Inc. on their inaugural 510(k) clearance for the Solo Pace Control. This innovative device is designed to enhance cardiac rhythm management during procedures, reflecting the company's commitment to advancing medical technology. Applause to OVERFIBERS S.R.L. for obtaining 510(k) clearance for the OverCEM SA Universal, a dual-curing self-adhesive resin cement that streamlines dental procedures by eliminating the need for etching and priming, showcasing Overfibers' dedication to innovation in dental materials. Overfibers