Dror Ortho-Design, Inc. Launches ZSMILE User Experience Trial
Dror Ortho-Design, Inc. (“Dror” or the “Company”) (OTC PINK: DROR), an AI-based orthodontic platform company that has developed a proprietary…
Tag: FDA Clearance
Stryker’s Spine Guidance 5 Software featuring Copilot receives 510(k) clearance from FDA
Stryker (NYSE:SYK), a global leader in medical technologies, today announced that its Q Guidance System with Spine Guidance 5 Software…
Soterix Medical Announces FDA 510(k) Clearance of MEGA-IOM Intraoperative Neuromonitoring System
Soterix Medical Inc., the global leader in stimulation and synergistic monitoring technologies, announced today it has received a 510(k) clearance…
THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System (TMINI 1.1)
THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System (TMINI…
ColoTest for Colon Cancer Screening Now Available at Select Walmart Locations
Reese Pharmaceutical, a privately held manufacturer of over-the-counter (OTC) branded and private label products today announced ColoTest®, its new Fecal…
Penumbra Launches Lightning Flash 2.0 – Latest CAVT Technology Designed to Rapidly Remove Blood Clots
Penumbra, Inc. (NYSE: PEN), the world’s largest thrombectomy company, announced the U.S. Food and Drug Administration (FDA) clearance and launch…
DIGITAL THERAPEUTICS STARTUP RESPIREE™ ANNOUNCES INCORPORATION IN US WITH RESIDENCY AT JLABS @ SAN FRANCISCO
Respiree announced today that it has incorporated in the US and will be incubating within Johnson & Johnson Innovation –…
FDA Grants HemoSonics Expanded Use of its Critical Bleeding Management System with Special 510(k) Clearance
HemoSonics, a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the…
DRAWBRIDGE SECURES FDA 510(K) CLEARANCE FOR AT-HOME BLOOD SAMPLING DEVICE NANODROP
Drawbridge Health, a healthcare technology company focused on reinventing the blood draw experience, today announced that its at-home, patented blood…
HeadaTerm 2: The Most Affordable FDA Cleared Innovative OTC Anti-Migraine Device
WAT Medical Enterprise achieves a major milestone: HeadaTerm 2 receives the OTC clearance from the U.S. Food and Drug Administration (FDA),…