Posts by rw-admin
Levita® Magnetics Wins FDA Clearance for Pioneering MARS™ System
Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration (FDA) clearance for its MARS™ platform. The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and…
Read MoreExactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene
Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced 510(k) clearance from the U.S. Food and Drug Administration for its new, advanced Activit-E™ polyethylene for the Truliant® knee replacement system. “After years of research and development in polyethylene, Activit-E represents a breakthrough achievement for Exactech,” said Adam…
Read MoreInBody Hits Milestone: 100 Million Tests Recorded Globally on Their LookinBody Web Platform
Highlighting a growing interest in body composition data, InBody is celebrating a long-anticipated milestone: 100 million tests taken globally on their body composition analyzers as of Friday, Aug. 4. “We’ve come a long way since InBody’s founding in 1996,” said Harry Yun, CEO of InBody USA. “The popularity of our tests is skyrocketing. Even the…
Read MoreWelldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®
Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management. This 10th 510(k) clearance enables BlueStar to use connected insulin dosing…
Read MoreCeribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication
Ceribell, Inc.® announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. Centers for Medicare…
Read MoreViseon Inc. Announces Commercial Rollout and Initial Clinical Use of the 4K MaxView® System for Advanced Digital Visualization During Minimally Invasive Spine Surgery
Viseon Inc. announced the US commercial rollout and initial clinical use of the First-of-its-Kind 4K Advanced Visualization System for Minimally Invasive Spine Surgery. The Viseon MaxView 4K System is an enabling, towerless, state-of-the-art, advanced visualization system involving no capital equipment expense and occupying no operating room footprint, most accommodating in an ASC setting. The 4K…
Read MoreKerecis to Donate FDA-Approved Fish Skin for Burn Victims of Maui Wildfires
Kerecis®, the company pioneering the use of fish skin and fatty acids for tissue regeneration and protection, is donating its GraftGuide® fish-skin burn product for victims of the fires on Maui, Hawaii. Qualified medical personnel wanting to get fish-skin burn-treatment products for their patients should call 703-287-8752 or email wildfires@kerecis.com. Kerecis is dispatching a specialist to train…
Read MoreAcorai receives Breakthrough Device Designation for their Non-Invasive Intracardiac Pressure Monitor
Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Acorai’s Heart Monitor, a device for the non-invasive estimation of diastolic pulmonary artery pressure (dPAP), systolic pulmonary artery pressure (sPAP), and mean pulmonary artery pressure (mPAP) in patients with Stage C Heart…
Read MoreCapstan Medical Leverages Robotics to Bring Minimally Invasive Care to Heart Valve Patients
Capstan Medical, a developer of minimally invasive technology to address heart valve disease, today announced an oversubscribed $31.4 million Series B investment led by Eclipse. Additional participating investors include Intuitive Ventures and Puma Venture Capital, a new firm founded by Amit Hazan, a veteran Wall Street medical technology analyst, and Dr. Vipul Patel, a renowned robotic surgeon who…
Read MoreFluidAI’s artificial intelligence-powered postsurgical monitor, Stream™ Platform, launches globally
Canadian medical technology company, FluidAI Medical (FluidAI), is set to revolutionize postoperative care with the launch of its ground-breaking medical device, the Stream™ Platform in Canada and Saudi Arabia. Through the use of the Stream™ Platform, surgeons have the potential to make a more accurate and timely diagnosis of postoperative leaks, dreaded complications of digestive tract surgeries, which can lead…
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