medical device guru

Surgery and Surgical Robotics
THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System
THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI™ Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The TMINI system includes a wireless robotic handpiece...
May 30, 2023
Diagnostics & Healthcare News
Biosency detects early COPD exacerbations thanks to Bora care®, a predictive digital medical device
The American Thoracic Society International Conference (ATS 2023) took place in Washington, D.C. from 19 to 24 May 2023. During the conference on 23 May, French MedTech Biosency unveiled its latest clinical results demonstrating the ability of its BVS3 technology to predict acute COPD (chronic obstructive...
May 26, 2023
Diagnostics & Healthcare News
iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool
iPredictTM AI Eye Screening System provides fully automated age-related macular degeneration (AMD) screening, including retinal imaging and immediate reporting of actionable results. Using the iPredictTM System, primary care and various specialty practices can accurately and efficiently screen people over 50 for AMD and...
May 24, 2023
Biologics, Wound Care, Infection Prevention
Cartessa Aesthetics Introduces Helix by DEKA, a Powerful Fusion of Skin Resurfacing Technology
In the growing category of non-invasive, energy-based aesthetic procedures, laser skin resurfacing occupies one of the largest shares. Laser resurfacing is an effective way to reduce the appearance of fine lines, wrinkles, scars, unwanted pigment, and improve skin’s tone and...
May 23, 2023
Imaging Visualization & Navigation
Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System
Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The Orlucent system is a handheld point-of-care...
May 22, 2023
Cardiovascular / Cardiology
PaceMate Announces Collaboration with AliveCor to Offer Cutting-Edge Remote Monitoring Platform
PaceMate® announced today its collaboration with AliveCor®, the global leader in FDA-cleared personal electrocardiogram technology and remote patient management solutions for the cardiovascular industry. This collaboration will combine the strengths of PaceMate’s world-class cardiac remote monitoring platform, PaceMateLIVE™ – designed to...
May 19, 2023
Surgery and Surgical Robotics
Paradromics Raises $33 Million in Funding, Achieves Breakthrough Medical Device Designation from FDA
Paradromics Inc., the leading developer of high data-rate brain-computer interfaces (BCI), today announced a $33 million Series A funding round led by Prime Movers Lab. Additional investors include Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity. The new funding will...
May 18, 2023
Imaging Visualization & Navigation
Koning Sees Surge in Orders Following Recent Installations at Prominent Hospitals and Attendance at the Society of Breast Imaging Symposium
Koning Corporation, the leading manufacturer of breast computed tomography (CT) systems, announced today that it has received the largest pipeline of orders in its history. The company has seen a surge in demand for its innovative Koning Vera Breast CT...
May 16, 2023
Diagnostics & Healthcare News
Bionix® Introduces IsoMark™ A Revolutionary Patient Marking Device for Radiation Oncology Treatment
For more than a decade, Bionix has supplied the radiation oncology sector of the healthcare industry with Accu-Tatt®, an all-inclusive, sterile, single-use tattooing device that marks targeted areas on a patient’s body for proper alignment during radiation therapy procedures. Working...
May 15, 2023
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