CHICAGO / Jun 26, 2024 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-AF device that uses AI to help identify patients who may be at increased risk of atrial fibrillation/flutter (AF). This is the first FDA clearance for an AF indication in the category known as...Read more
Combined vitreoretinal-cataract system (VCS) and standalone cataract system (CS) are cleared for use in the U.S. New, proprietary technologies designed to deliver transformative surgical innovation Alcon to immediately begin collecting real-world user experience in the U.S. prior to broad commercialization in 2025 First innovations to be introduced from Alcon’s cutting-edge Unity portfolio of surgical equipment Ad Hoc Announcement...Read more
Clinically proven to improve attention function, EndeavorOTCⓇ is the first and only digital therapeutic cleared by FDA as an over-the-counter treatment for adults with ADHD BOSTON / Jun 18, 2024 / Business Wire / Akili, Inc. (Nasdaq: AKLI), a leading digital therapeutics company, today announced U.S. Food and Drug Administration (FDA) clearance of EndeavorOTCⓇ (AKL-T01) as an over-the-counter treatment for adults with...Read more
The solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited. This clearance is a...Read more
RA'ANANA, Israel, May 28, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company", "Inspira", or "Inspira Technologies"), a breakthrough medical technology company, today announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass System. Dagi Ben Noon, CEO of Inspira, said "This...Read more
Prostate segmentation using a deep learning convolutional neural network Model uses 24,611,072 parameters extracted from 7,466 training images Validated in standalone and multi-reader, multi-case clinical studies conducted by world-renowned experts Urologists testing this TULSA-AI module improved their segmentation accuracy and were 32% faster in their contours TORONTO, May 14, 2024 (GLOBE NEWSWIRE) --...Read more
LEWISVILLE, Texas / May 09, 2024 / Business Wire / Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail. The Rodeo Telescopic Nail is an innovative device indicated to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta (OI). The nail...Read more
SAN JOSE, Calif. / May 06, 2024 / Business Wire / Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of TabloCartTM with prefiltration, an innovative optional accessory for the Tablo® Hemodialysis System. Outset has resumed distribution...Read more
The portable vital signs monitor (VSM) adds to GE HealthCare’s growing Portrait Ecosystem to help clinicians make timely treatment decisions and detect patient deterioration earlier with a streamlined spot check workflow, while ensuring patient mobility. Portrait VSM uses proven and innovative capabilities to provide precise readings for blood pressure, pulse rate, oxygen saturation, body temperature and respiratory rate. CHICAGO /...Read more
SOLANA BEACH, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received 510(k) clearance for its Prism Bone Anchor Accessory. This clearance marks the Company’s second new product introduction within the first four months of 2024. “Similar to the recent launch...Read more
New Indication for Treatment of Pulmonary Embolism Enhances Device Utility in Critical Medical Scenarios LATHAM, N.Y. / Apr 04, 2024 / Business Wire / AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced that the United States Food and...Read more
BOSTON, April 4, 2024 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the TEG® 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge. This new cartridge extends Haemonetics' TEG 6s viscoelastic...Read more
Test Delivers on Company Commitment to Advance the Power of Diagnostics to Empower Patients with Rapid Results in Just 10 Minutes Savanna® RVP4+ Assay Research and Development Update SAN DIEGO / Apr 02, 2024 / Business Wire / QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test. This clearance allows the test to be...Read more
Novum IQ Infusion Platform now offers large volume and syringe infusion smart pumps on an integrated system with shared innovative digital health solutions to help enhance patient safety and efficiency for clinicians Common user interface and connectivity across both pump modalities are designed to help reduce workflow burden and allow more time focused on patient care DEERFIELD, Ill. / Apr 01, 2024 / Business Wire / Baxter...Read more
GE HealthCare to exclusively distribute nCommand Lite by IONIC Health for multi-vendor, multi-modality remote operations capabilities CHICAGO / Mar 25, 2024 / Business Wire / GE HealthCare (Nasdaq: GEHC) announces the U.S. FDA 510(k) Clearance of IONIC Health’s nCommand Lite technology. The vendor-agnostic, multi-modality nCommand Lite system will be distributed exclusively by GE HealthCare and will provide remote patient scanning...Read more
SUNNYVALE, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that the U.S. Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company’s next-generation multiport robotic system. “We are pleased to receive FDA clearance for our fifth-generation robotic system, da Vinci 5,” said...Read more
HAYWARD, Calif. / Mar 08, 2024 / Business Wire / Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its novel CellFX nsPFA Percutaneous Electrode System for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. “The FDA...Read more
Nevro1™ Proven to Immediately Transfix Sacroiliac (SI) Joint to Allow for Long-term SI Joint Fusion REDWOOD CITY, Calif., Feb. 28, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) cleared its sacroiliac joint fusion device, which will be marketed as...Read more
RA'ANANA, Israel, Feb. 27, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, has announced that the Company is progressing towards 510(k) clearance from the U.S. Food & Drug Administration ("FDA") for its INSPIRA™ ART100 in the first half of 2024. The Company plans additional FDA 510(k) submissions for the HYLA...Read more
SOUTH JORDAN, Utah, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, has received US Food and Drug Administration (FDA) 501(k) clearance for the SCOUT® MD™ Surgical Guidance System. The release of the new guidance system demonstrates Merit’s ongoing leadership in oncology and marks a significant advancement in breast cancer care. SCOUT MD broadens Merit’s oncology...Read more
Nanox’s HealthFLD is pioneering the use of a fully automated AI software for liver attenuation analysis from CT scans that has received FDA 510(k) clearance for use in general population Expands Nanox’s offering in AI solutions, marking third product in Nanox AI’s suite of population health solutions to become commercially available PETACH TIKVA, Israel, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Nano-X Imaging ("Nanox" or the "Company,"...Read more
LEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to the expansive...Read more
GE HealthCare receives FDA clearance for expanded indication for Novii+ maternal and fetal monitoring solution for pregnant patients ≥34 weeks. Novii+ noninvasively measures and displays fetal heart rate, maternal heart rate and uterine activity, while providing patient comfort and mobility in the hospital. CHICAGO / Feb 01, 2024 / Business Wire / GE HealthCare (Nasdaq: GEHC) today announced it has received 510(k) clearance from the...Read more
SANTA CLARA, Calif., Jan. 30, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announces FDA 510(k) premarket clearance of the iFuse Bedrock Granite® Implant System (Granite) in a smaller (9.5 mm) diameter with both an expanded indication in pediatric patients and an expanded application that includes use in the...Read more
PLEASANTON, Calif., Jan. 30, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ: OSA) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced today that the United States Food and Drug Administration (the “FDA”) has accepted, and is in the process of reviewing, the Company’s premarket notification for its ProSomnus® EVO® precision medical device for the treatment of patients with severe obstructive sleep...Read more
225-cm Catheter Length Expands Access Points in Atherectomy Procedures to Help Reduce Access Site Complications and Accelerate Patient Recovery LATHAM, N.Y. / Jan 23, 2024 / Business Wire / AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today...Read more
SAN DIEGO, CA / ACCESSWIRE / January 19, 2024 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a development-stage, insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, today announced the premarket submission of its MODD1 next-generation insulin pump to the FDA for 510(k) clearance. "This is an exciting milestone for the Company, as...Read more
SOLANA BEACH, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received 510(k) clearance for its SmartFrame OR™ Stereotactic System. The SmartFrame OR Stereotactic System is composed of two main components: the SmartFrame OR, and the ClearPointer™ Optical...Read more
PARSIPPANY, N.J., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Embecta Corp. ("embecta") (Nasdaq: EMBC), a global diabetes care company with a 100-year legacy in insulin delivery, today announced that it has submitted a 510(k) premarket filing to the U.S. Food and Drug Administration (FDA) for a proprietary disposable insulin delivery system. "This patch pump is intended for people who require insulin to manage diabetes and is informed by the...Read more
LEXINGTON, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to expand the use of its FDA-cleared T2Candida® Panel to include pediatric testing. The T2Candida Panel is the only FDA-cleared...Read more
HAYWARD, Calif. / Jan 02, 2024 / Business Wire / Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel CellFX nsPFA Cardiac Clamp. Pursuant to Section 510(k), once...Read more
Savanna delivers results in 25 minutes or less, improves clinical care, provides cost savings and delivers sample-to-result molecular testing across all laboratory settings SAN DIEGO / Dec 20, 2023 / Business Wire / QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received 510(K)...Read more
Stork Provides Continuous Monitoring of Oxygen Saturation, Pulse Rate, and Skin Temperature, with Alarms, for Sick and Healthy Babies at Home IRVINE, Calif. / Dec 18, 2023 / Business Wire / Masimo (NASDAQ: MASI), a global leader in innovative monitoring technologies used in top hospitals, announced today FDA clearance of Stork™, a revolutionary baby monitoring system, for prescription use with healthy and sick babies 0-18 months of...Read more
MALVERN, Pa., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced the U.S. Food and Drug Administration 510(k) clearance of NeuroSite™ Coil Placement Accessory, a state-of-the-art tool that simplifies measurement and coil positioning during...Read more
Over 80% of gastric cancers are attributed to H. pylori bacterial infection Gastric cancer is the third most common cause of cancer related death in the world H. pylori infection is also a major cause of peptic ulcers IRVINE, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic products, today announced it has received U.S. Food and Drug...Read more
HALIFAX, NOVA SCOTIA / ACCESSWIRE / December 13, 2023 / MedMira Inc. (MedMira) (TSXV:MIR) proudly announces today the successful attainment of 510(k) clearance for the HIV-2 claim on the Reveal® G4 Rapid HIV-1/2 antibody test in the United States. This achievement marks a significant milestone for MedMira, positioning the company as a key player in the HIV testing landscape and addressing the demand for comprehensive HIV screening...Read more
First FDA-cleared thin-film, sEEG-guided RF system capable of both recording electrical activity and ablating nervous tissue with the added benefit of temperature control; Marks the Company’s third FDA 510(k)-cleared device Potential for transformative improvement in neurosurgery procedures; Company targets commercial launch in first half of 2024 EDEN PRAIRIE, Minn., Dec. 11, 2023 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies...Read more
BD MiniDraw™ Capillary Blood Collection System Enables Lab-Quality Blood Testing from Less Invasive Method than Venous Collection in More Convenient Locations FRANKLIN LAKES, N.J., Dec. 7, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearances from the U.S. Federal Drug Administration (FDA) for a novel blood collection device...Read more
Southlake, TX, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that it has received confirmation from the FDA to change the clearance pathway for its MyoVista® wavECG™...Read more
West expands administration systems portfolio with new smaller size needle-free admixture device for immediate use IV drug transfer designed to maximize the benefits of point-of-care nursing. EXTON, Pa., Dec. 4, 2023 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration systems, today announced FDA 510(k) clearance and launch of its...Read more
LITTLETON, Colo., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe obstructive...Read more
As part of the latest Critical Care Suite 2.1 offering, new on-device AI helps detect and localize pneumothorax (PTX) – providing immediate notification and overlay for the presence or absence of PTX. Results from various clinical studies showed significant user benefits - including a 57% reduction in reporting times for clinical actionable PTXs;1 a 17.7% increase in clinician detection of small PTXs;2 and a 100% partial localization...Read more
IONIC Health will add multi-vendor, multi-modality remote scanning capabilities to GE HealthCare's portfolio of effortless operations solutions, including the recently FDA-cleared Digital Expert Access with remote scanning. CHICAGO / Nov 21, 2023 / Business Wire / GE HealthCare (Nasdaq: GEHC) has received U.S. FDA 510(k) Clearance for the new version of Digital Expert Access with remote scanning, the first remote patient scan solution...Read more
HAYWARD, Calif. / Nov 21, 2023 / Business Wire / Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel CellFX nsPFA percutaneous electrode. The Company’s...Read more
IRVINE, Calif. / Nov 17, 2023 / Business Wire / Masimo (NASDAQ: MASI) today announced that the Masimo W1™ medical watch has received FDA 510(k) clearance for over-the-counter (OTC) and prescription use (Rx). Masimo W1 is the first FDA-cleared watch to provide continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx use. The FDA clearance expands the indications for the Masimo W1 in the U.S. as a medical device for...Read more
MAHWAH, N.J. / Nov 07, 2023 / Business Wire / KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty subcutaneous infusion solutions that improve quality of life for patients, today announced that it received U.S. Food and Drug Administration (FDA) clearance for use of the...Read more
Feedback from responses to FDA anticipated in 30 days Commercialization remains on track in first half of 2024 pending FDA clearance Product potential for transformative improvement in neurosurgery as first known sEEG-guided RF system that records and ablates nervous tissue with the added benefit of temperature control EDEN PRAIRIE, Minn., Nov. 07, 2023 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC)...Read more
ACTON, Mass. / Oct 23, 2023 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received FDA 510(k) clearance for the Omnipod 5 App for iPhone, making Insulet the first and only company to offer a tubeless automated insulin delivery (AID) system with full control from a compatible Android and iOS...Read more
Building on the award-winning Allia platform for image guided therapies, the new Allia IGS Pulse was designed to improve workflow for the diagnosis and treatment of cardiovascular diseases in interventional cardiology. As part of its new image chain, the system features the first monopolar x-ray tube used for interventional procedures – providing exceptional image quality and optimized dose management regardless of patient size -...Read more
Flora is the only magnet-free and MR Conditional tissue expander cleared for the U.S. market. NEW YORK / Oct 16, 2023 / Business Wire / Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Motiva Flora®...Read more
LEWISVILLE, Texas / Oct 12, 2023 / Business Wire / Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the 510k clearance and full commercial launch of OsteoCove™, an advanced bioactive synthetic graft. Available in both a putty and strip configuration, OsteoCove was carefully formulated to provide superior bone-forming capabilities with best-in-class handling characteristics for a wide range...Read more
TORONTO, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA) for the Company’s Thermal Boost module for use in conjunction with...Read more
The 510(k) Clearance from the United States Food and Drug Administration (FDA) allows for the U.S. commercialization of FemaSeed®, an intratubal artificial insemination option designed to augment the natural fertilization process FemaSeed® is an innovative infertility treatment designed to deliver sperm directly to where conception occurs in a woman’s fallopian tube ATLANTA, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:...Read more
LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel. The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S....Read more
TORONTO, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Venus Concept Inc. ("Venus Concept" or the "Company") (NASDAQ: VERO), a global medical aesthetic technology leader, announced today that it has received a 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its Venus Versa Pro System, the Company’s new multi-application platform, for a variety of aesthetic and cosmetic procedures. Venus Versa is a modular system based...Read more
Pangea to offer a comprehensive and versatile portfolio, providing variable-angle plating for a variety of patient populations KALAMAZOO, Mich. / Sep 12, 2023 / Business Wire / Stryker (NYSE: SYK), one of the world’s leading medical technology companies, announced that its Pangea Systems including Femur, Fibula, Tibia, Humerus and Utility have received 510k clearance from the U.S. Food & Drug Administration. “FDA clearance is a...Read more
WARSAW, Ind., Sept. 11, 2023 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Pediatric Nailing Platform | Tibia (“PNP Tibia”) surgical system. Part of the Trauma & Deformity Correction suite of products, PNP Tibia...Read more
510(k) clearance will allow 23andMe to report an additional 41 genetic variants in the BRCA1 and BRCA2 genes that increase risk for breast, ovarian, prostate and pancreatic cancer Many of these additional variants occur more often in people of African American and Hispanic/Latino descent 23andMe also granted an FDA Predetermined Change Control Plan, allowing the company to update its BRCA report with additional variants without a...Read more
LONDON / Aug 30, 2023 / Business Wire / LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures. The ILBM is integrated into...Read more
The clinician-driven design of the precision system is the foundation of ICU Medical's long-term IV systems product road map that seeks to blend ease of use with proven medication delivery and safety SAN CLEMENTE, Calif. , Aug. 29, 2023 /PRNewswire/ -- ICU Medical Inc., a worldwide leader in the development, manufacture and sale of innovative medical devices, today announced that the company has received 510(k) regulatory...Read more
WALTHAM, Mass., Aug. 23, 2023 /PRNewswire/ -- Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for Versi®HD with GuideMe Software, a completely reinvented self-guided interface for the company's VersiHD chronic home hemodialysis (HHD) system. VersiHD with GuideMe Software aims to transform the...Read more
Complete Integrity Implant System is now fully cleared; targeting launch in Q1-2024 Integrity is highly differentiated by its knitted structure, resulting in higher strength and greater regenerative capacity compared to first generation bovine collagen patches1 Integrity marks Anika’s expansion of its proprietary regenerative portfolio and entrance into the over $150 million2 U.S. rotator cuff augmentation market BEDFORD, Mass.,...Read more
GE HealthCare’s smart phone-sized Portrait Mobile frees the patient from the hospital bed while providing continuous monitoring of vital signs, using wearable sensors with a wireless protocol, to help catch inpatient deterioration early. Portrait Mobile introduces an innovative measurement technology to continuously capture respiration rate, one of the most sensitive vital signs for early patient deterioration1,2, accurately and...Read more
The Radixact System, with the addition of the VitalHold functionality, provides clinicians with unmatched choice of radiation treatment delivery options in one device Treatment delivery versatility offers opportunities for personalization and makes exceptional quality care possible for more breast cancer patients MADISON, Wis., Aug. 9, 2023 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the company has...Read more
DUBLIN, Ireland, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Trinity Biotech has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Premier Resolution System, an automated analyzer for the accurate & precise quantification of hemoglobins F and A2, and the detection of >200 hemoglobin variants. The Premier Resolution System is now cleared for sale in the United States. The Premier Resolution System is a lab-based...Read more
WAYNE, Pa., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+™ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy. This allows clinicians to use the QuikClot Control+™ Device to control all...Read more
Single Test on BD MAX™ System Identifies and Differentiates Multiple Respiratory Infectious Diseases from One Sample FRANKLIN LAKES, N.J., Aug. 1, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic...Read more
ANAHEIM, Calif., July 25, 2023 /PRNewswire/ -- Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demonstrating ongoing commitment to product innovation in the in vitro diagnostic industry. Designed for small-to-medium-sized laboratories, the DxC 500 AU Chemistry Analyzer...Read more
BD Alaris™ Infusion System is the only modular and most comprehensive infusion system on the U.S. market that includes large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring, auto-identification, dose error reduction software and EMR interoperability BD Alaris™ Infusion System's unique "One System" platform securely connects all patient modules to provide care teams with a single,...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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