Posts by rw-admin
INSIGHTEC wins Medicare Coverage for MR-Guided Focused Ultrasound Platform
INSIGHTEC, a global medical technology innovator of incisionless surgery, announced today achievement of complete Medicare coverage across all 50 states for MR-guided focused ultrasound treatment of medication-refractory Essential Tremor. “INSIGHTEC is committed to expanding patient access for MR-guided focused ultrasound,” said Dee Kolanek, INSIGHTEC Vice President of Reimbursement. “The efforts of our team have made complete…
Read MoreFDA Green-lights Infervision’s Deep Learning Tool for Segmenting Lung CT Scans
Infervision is pleased to announce the U.S. Food and Drug Administration (FDA) 510(K) clearance of the InferRead Lung CT.AI product, which uses the state-of-the-art artificial intelligence and deep learning technology to automatically perform lung segmentation, along with accurately identifying and labeling nodules of different types. InferRead Lung CT.AI is designed to support concurrent reading and…
Read MoreFDA Clears Nonin Medical’s Flagship Product
Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation. It’s also expected to prove useful…
Read MoreNuVera Medical Announces Successful First-in-Human Use of NuVision ICE Catheter
NuVera Medical Inc. (NuVera), a portfolio company of Shifamed LLC, focused on enabling a new era in transcatheter cardiac interventions through the advancement of real-time 3D intracardiac echocardiography (4D ICE), announced today initiation of the company’s first-in-human clinical trial to evaluate the performance of its novel NuVision™ ICE Catheter. The first study participant was successfully treated this…
Read MoreUK Watchdog Skeptical of Stryker’s $4B Wright Medical Dea
The U.K. Competition and Markets Authority on Tuesday raised concerns that Stryker’s proposed $4 billion acquisition of Wright Medical Group could result in the medtech giant controlling 90% of Britain’s total ankle replacement prostheses market, leading to higher prices and less choice for hospitals and patients. CMA warned that the anti-competitive nature of the Stryker-Wright deal could have a negative…
Read MoreCVRx Announces Publication of BeAT-HF Clinical Study Results in the Journal of The American College of Cardiology
CVRx, Inc., a private medical device company, announced today that its BeAT-HF phase III randomized clinical trial results were published in the Journal of the American College of Cardiology (“JACC”). Results from the trial were used to obtain Premarket Approval (PMA) from the United States Food and Drug Administration (“FDA”) to market its BAROSTIM NEO…
Read MoreEO and UVDI Lead Trans-Pacific Fight to Flatten the COVID-19 Curve
EO Medical Pte. Ltd., announced in partnership with UltraViolet Devices, the global leader in UV-C disinfecting robots, that six additional UVDI-360 robots have been deployed in Singapore to curb the spread of coronavirus. UVDI-360 UV-C robots, manufactured in the greater Los Angeles area, are the most widely used disinfecting robot in Singapore’s top hospitals. “Protecting…
Read MoreLeMaitre Vascular Buys Artegraft for $90M
LeMaitre Vascular, Inc. announced that it has acquired the business and assets of Artegraft, Inc. for $90.0 million, including $72.5 million in cash paid at closing ($65.0 million to Artegraft plus $7.5 in escrow to be released December 31, 2021) as well as potential earnout payments of $17.5 million payable based upon future sales of…
Read MoreBreakthrough Device Designation Given for preCARDIA’s Catheter Based Heart Failure Treatment
preCARDIA, Inc., has announced that the company’s catheter based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). The FDA’s Breakthrough Device Program was established for medical technologies that have the potential to provide more…
Read MoreFirst US Patients Treated Using the CardioFocus HeartLight X3 Ablation System
CardioFocus, Inc. today announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight® X3 Endoscopic Ablation System. The revolutionary cardiac ablation technology is designed to treat drug refractory, symptomatic paroxysmal atrial fibrillation (AFib), the most common heart rhythm disorder. Henry D. Huang, M.D., FACC, FHRS of Rush University Medical Center in Chicago, and David Kenigsberg M.D., FACC, FHRS…
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