Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance from the United States Food & Drug Administration for a stemless anatomic total shoulder for the AETOS Shoulder System (AETOS Stemless). AETOS Stemless addresses the growing demand for anatomic total shoulder replacement with a small operating room footprint allowing for an efficient procedure.1 It is...Read more
First cable-free, ambulatory ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics Patients can have the credit card-sized device with them at all times, ready to record an ECG whenever they feel symptoms and reduce delays in care Company to initiate Early Access Program to gain important patient and physician feedback on the use of the system in...Read more
New Anatomically Shaped Asymmetric Stemless Design for Total Shoulder Replacement WARSAW, Ind., Dec. 13, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the OsseoFit™ Stemless Shoulder System for total shoulder replacement. This innovative implant is designed to match the natural...Read more
LATHAM, N.Y. / Dec 09, 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 it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NanoKnife System for prostate tissue ablation. The Company received...Read more
Nanox.ARC receives additional FDA clearance to produce tomographic images for general use, including pulmonary, intra-abdominal and paranasal indications, in addition to its previously cleared indication for the musculoskeletal system Nanox.ARC uses high voltage powered digital X-ray tubes for 3D tomosynthesis imaging that could help expand availability of medical imaging Nanox.ARC now deployed at healthcare facilities across seven...Read more
A Total Knee Replacement Alternative for Patients with Metal and/or Bone Cement Sensitivities WARSAW, Ind., Dec. 4, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® SoluTion™ Porous Plasma Spray (PPS®) Femur, a total knee implant component offering an alternative for patients...Read more
Company's first 510(k) clearance unlocks a TAM of $40 billion in healthcare B2B opportunities PLEASANTON, Calif., Dec. 2, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring. The clearance enables Movano Health to pursue multi-billion dollar business opportunities for health...Read more
SmartMammo™’s AI algorithm now FDA cleared with GE HealthCare’s Senographe Pristina™, expanding access to enhanced cancer detection. The clearance enables RadNet’s DeepHealth and GE HealthCare collaboration to bring together the SmartMammo and Senographe Pristina solutions and transform breast cancer diagnosis. SOMERVILLE, Mass., Nov. 29, 2024 (GLOBE NEWSWIRE) -- DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc....Read more
New MRI technology aims to advance neuroimaging and biomarker research CHICAGO / Nov 13, 2024 / Business Wire / GE HealthCare (Nasdaq: GEHC) has received FDA 510(k) clearance for its innovative SIGNA™ MAGNUS,i a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This system offers new capabilities for both clinical imaging and neuroscience with the potential to aid in the detection of neurological, oncological,...Read more
BOULDER, CO / ACCESSWIRE / November 11, 2024 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food...Read more
Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) monitoring service for non-critical care patients FDA 510(k)-cleared enhancements will be available in 2025 SAN FRANCISCO, Oct. 30, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect,...Read more
SAN FRANCISCO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its 510(k) submission related to prior design changes made to the Zio AT device via letter to file. Zio AT remains commercially...Read more
The Pounce™ Thrombectomy Platform can now be used to remove clot from peripheral arteries as small as 2mm up to as large as 10 mm in diameter, broadening the platform's clinical utility and significantly expanding its addressable market EDEN PRAIRIE, Minn. / Oct 01, 2024 / Business Wire / Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced it has received U.S. Food...Read more
An automated platform designed to fight against Sepsis and Antimicrobial Resistance (AMR) Enables rapid, automated microbial identification on the Bruker MALDI Biotyper® CA System directly from positive blood culture samples TUCSON, Ariz., Sept. 30, 2024 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ: AXDX), an innovator of rapid in vitro diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted...Read more
Vivos is poised to disrupt the very significant pediatric obstructive sleep apnea (OSA) market with new FDA clearance and new strategic marketing and distribution model Vivos’ DNA appliance now approved to reduce snoring and treat moderate to severe OSA in children aged 6 to 17 LITTLETON, Colo., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and...Read more
BOULDER, CO / ACCESSWIRE / September 17, 2024 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food...Read more
ATLANTA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec®, an innovative diagnostic solution for checking the...Read more
While 9 out of 10 people with diabetes are living with T2D, many of the automated insulin delivery solutions currently on the market were designed for people living with T1D. 300-unit insulin reservoir is more suitable for people with T2D who are interested in moving from multiple daily injections (MDI) to pump therapy, based on an average daily dose of 95.9 units of insulin.1 PARSIPPANY, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) --...Read more
HealthCCSng V2.0 introduces additional ‘zero calcium’ categorization of coronary artery calcium (CAC) and generates a numerical calcium score with corresponding CAC detection category output Marks second FDA 510(k) clearance of HealthCCSng product PETACH TIKVA, Israel, Aug. 21, 2024 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that...Read more
SAN JOSE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI™ treatment planning, advanced...Read more
SANTA CLARA, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, announces FDA 510(k) clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next generation...Read more
Secure Bluetooth® Connectivity Allows Continuous, Accurate Wrist-based Measurements to be Seamlessly Relayed to Caregivers via the Masimo Secure Health Data Cloud IRVINE, Calif. / Aug 12, 2024 / Business Wire / Masimo (NASDAQ: MASI) today announced that the Masimo W1® medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet® comprehensive telemonitoring solution. Masimo W1...Read more
WAYNE, Pa., July 31, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Ringer™ Perfusion Balloon Catheter (PBC), the only commercially available Percutaneous Transluminal Coronary Angioplasty (PTCA) perfusion balloon.1 The Ringer™ PBC is a rapid-exchange 0.014” compatible catheter with a unique...Read more
Q Guidance System with Spine Guidance 5 Software featuring Copilot is a first-to-market technology, pioneering new planning and surgical capabilities LEESBURG, Va. , July 30, 2024 /PRNewswire/ -- Stryker (NYSE:SYK), a global leader in medical technologies, today announced that its Q Guidance System with Spine Guidance 5 Software featuring Copilot received 510(k) clearance from the U.S. Food and Drug Administration. This...Read more
Toronto, Ontario--(Newsfile Corp. - July 29, 2024) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), a developer and investment partner in a wide range of leading-edge, proprietary diagnostic and medical device technologies, is pleased to announce that the Company has received the U.S. Food and Drug Administration's (FDA) approval on its 510K application request to correct the Venowave VW5 device's intended...Read more
PALM BEACH GARDENS, Fla., July 23, 2024 (GLOBE NEWSWIRE) -- ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental market, today announced the U.S. launch of its GenTek® Genuine Restorative Components product portfolio. The launch expands ZimVie’s portfolio of end-to-end prosthetic offerings and follows the recent receipt of FDA 510(k) clearance. ZimVie first launched the GenTek portfolio in Europe in 2019 and has seen...Read more
RESEARCH TRIANGLE PARK, N.C., July 23, 2024 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a global leader of innovative digital solutions for the operating room, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for an expanded indication to treat adult and pediatric Urology patients with the Senhance® Surgical System. “This FDA clearance marks another milestone...Read more
AUDUBON, Pa., July 17, 2024 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced it recently received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for ExcelsiusFlex™ with Total Knee Arthroplasty (TKA) application. This new robotic navigation platform joins the already best-in-class Excelsius™ ecosystem, designed to offer surgeons control, resection accuracy,...Read more
IRVINE, Calif., July 17, 2024 /PRNewswire/ -- InMode Ltd. (NASDAQ: INMD), a leading global provider of innovative medical technologies, is pleased to announce an additional FDA 510(k) clearance for the Morpheus8 technology. Morpheus8 is the first and only fractional radiofrequency (FRF) microneedling technology cleared for contraction of soft tissue. The U.S. Food and Drug Administration (FDA) has cleared the use of the Morpheus8...Read more
Engineered for precision, confidence and efficiency in surgery - and compatible with the CORI◊ Surgical System Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance for its new CATALYSTEM Primary Hip System from the United States Food and Drug Administration. The system is designed to address the evolving demands of primary hip surgery including the increased adoption...Read more
LEWISVILLE, Texas / Jul 09, 2024 / Business Wire / Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the 510(k) clearance and first U.S. implant of the Fitbone™ Transport and Lengthening System. Used to treat large bone defects in the femur and tibia due to trauma, infectious or malignant conditions, the device is the only intramedullary nail designed to transport or lengthen the bone...Read more
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
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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