medical device guru

Imaging Visualization & Navigation
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,”...
July 13, 2020
Imaging Visualization & Navigation
FDA 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...
July 10, 2020
Cardiovascular / Cardiology
FDA 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...
July 9, 2020
Uncategorized
NuVera 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...
July 6, 2020
Diagnostics & Healthcare News
UK 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...
July 2, 2020
Cardiovascular / Cardiology
CVRx 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...
July 1, 2020
Biologics, Wound Care, Infection Prevention
EO 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...
June 26, 2020
Cardiovascular / Cardiology
LeMaitre 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)...
June 24, 2020
Cardiovascular / Cardiology
Breakthrough 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...
June 23, 2020
1 2 3 128