Posts by cstephenson@legacymedsearch.com
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 molecular-based imaging system designed to noninvasively identify and clinically assess the presence of biological tissue…
Read MorePaceMate 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 improve clinical, operational, and financial outcomes – with AliveCor’s KardiaPro platform to capture and triage…
Read MoreParadromics 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 help Paradromics launch its first-in-human clinical trial for the Connexus® Direct Data Interface (DDI). In addition…
Read MoreKoning 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 system from healthcare providers around the world, as they seek to improve breast cancer detection…
Read MoreBionix® 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 with an inventive medical professional with years of experience applying tattoos to patients to prepare…
Read MoreNovarad’s VisAR Receives FDA Clearance for Augmented Reality Surgical Navigation in Spinal Surgery in Indonesia
Novarad’s VisAR, a surgical navigation system that uses augmented reality, has received clearance from Indonesia’s FDA for intraoperative use in stereotactic spinal surgery. VisAR is accurate for both open and minimally invasive surgery (MISS). This cutting-edge technology enables surgeons to transform a patient’s imaging data into a 3D hologram, which can be projected onto the patient’s body with…
Read MoreCardiaCare Names Ken Nelson Chairman of its Board of Directors
CardiaCare, a clinical stage digital therapeutic company developing the world’s first non-invasive, neuromodulation wearable for atrial fibrillation treatment, announced today that Ken Nelson has been appointed Chairman of the Board. Mr. Nelson is a 20-year digital health, medical device, and remote patient monitoring executive with a stellar track record of building successful sales, marketing and commercialization teams…
Read MoreProvidence Medical Technology Announces Completion of Enrollment in the FUSE Clinical Study for High-Risk Cervical Fusion Patients
Providence Medical Technology, Inc. (PMT), a leader in medical device innovation for spine surgery, today announced the close of enrollment in its FUSE Study — a prospective, multicenter, randomized, Investigational Device Exemption (IDE) clinical study evaluating the safety and effectiveness of its Posterior Cervical Stabilization System (PCSS) in 3-level cervical fusion patients. The study enrolled…
Read MoreSibel Health Announces a New FDA-Clearance for Advanced Wireless Monitoring in Neonates and Infants
Sibel Health, an award-winning digital health company spun out of the Querrey Simpson Institute for Bioelectronics at Northwestern University, announces a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape…
Read MoreVirtuoso Surgical Unveils Design of Groundbreaking Robotic Surgery System
Nashville-based medical device company Virtuoso Surgical, Inc. has unveiled its revolutionary robotic surgery system. Virtuoso’s patented technology reimagines endoscopic surgery in scale, function and cost. “Virtuoso gives surgeons their hands back, equipping them to lift tissue, apply tension and maintain traction – in tight spaces within the body,” said S. Duke Herrell, III, MD, FACS, CEO, Co-Founder and Chief Medical Officer…
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