Brain-computer interface (BCI) trials may soon be more accessible to a greater population of candidates living with paralysis, per a new partnership agreement between Blackrock Neurotech, a leader in implantable brain technology, and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL). The agreement sets the stage for Pitt RNEL to scale future brain-computer… Continue reading Blackrock Neurotech and University of Pittsburgh to Expand Reach of Brain-Computer Interface Trials with In-Home System
Category: Medical Devices
Read Magazine provides latest news and granular market insights from the Medical Devices, Covid19, Pandemic, Pharma, and allied domains.
New Korus Technology Set to Transform Industry Standards in Elutriation and Cell Wash
Invetech launches Korus, a closed system for autologous cell therapies that features elutriation and cell wash using gentle counterflow centrifugation. Korus has the potential to transform cell therapy industry standards, with supporting data demonstrating improved manufacturing performance compared to samples prepared by standard washing. The system delivers purified cell populations for downstream processing development and… Continue reading New Korus Technology Set to Transform Industry Standards in Elutriation and Cell Wash
Caption Health Launches First In-Home Ultrasound Service for Heart Health: Caption Care
Caption Health, the AI leader that enables earlier disease detection, unveiled Caption Care™: America’s first in-home heart wellness assessment and low-cost echo service. Through a partnership with Portamedic, Inc., one of the largest U.S. providers of in-home medical services, mobile technicians across the country will use the Caption AI platform to perform cardiac ultrasounds in… Continue reading Caption Health Launches First In-Home Ultrasound Service for Heart Health: Caption Care
Ceruvia Lifesciences Submits FDA Investigational New Drug Application for NYPRG-101 Migraine Prevention Program
Ceruvia Lifesciences, a leading neurotransformational medicine biopharmaceutical company today announced the submission of an IND application to begin a Phase 1, single center, randomized, double blind, placebo controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NYPRG-101 (2-bromo-D-lysergic acid diethylamide) in healthy adult participants. Also Read: Sonivie Receives Ide Approval… Continue reading Ceruvia Lifesciences Submits FDA Investigational New Drug Application for NYPRG-101 Migraine Prevention Program
Inspired Spine Announces Completion of over 1500 OLLIF Procedures
Inspired Spine reached the milestone of completing 1,500 Oblique Lateral Lumbar Interbody Fusion (OLLIF) procedures. This minimally invasive surgical technique is designed to improve the performance of lumbar interbody fusions by delivering superior outcomes including less patient recovery time and minimal blood loss, while requiring a procedure duration as short as 30 minutes. The OLLIF… Continue reading Inspired Spine Announces Completion of over 1500 OLLIF Procedures
Conformal Medical Announces Launch of CONFORM Pivotal Trial
Conformal Medical, Inc., a medical device company developing next-generation LAAO technology, announced the launch of the CONFORM pivotal trial with the enrollment of the first patients at two U.S. sites. The investigational device exemption (IDE) study will evaluate the safety and efficacy of the company’s CLAAS System compared to commercially available LAAO devices to support… Continue reading Conformal Medical Announces Launch of CONFORM Pivotal Trial
Sonivie Receives Ide Approval From FDA for Its Pilot Study to Treat Hypertension
SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS™) to treat a variety of hypertensive disorders, announced that on May 5th 2022 the U.S. Food and Drug Administration granted IDE approval for its “REDUCED1” Pilot study to treat Resistant Hypertension Patients with Renal Artery Denervation using TIVUS™, its innovative Ultra-Sound Ablation… Continue reading Sonivie Receives Ide Approval From FDA for Its Pilot Study to Treat Hypertension
MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA
MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Cybersecurity is pleased to announce its role in the granting of the DeNovo by the U.S. Food and Drug Administration (FDA) for BONESUPPORT’S CERAMENT G, an implantable… Continue reading MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA
Florida Plastic Surgeons Using New Clarius Wireless Ultrasound to Comply with Emergency Order Mandating Ultrasound Guidance for Safer BBL Procedures
Clarius Mobile Health reports that sales of the new Clarius L7 HD3 wireless scanner to plastic surgeons are soaring following the Florida Board of Medicine’s recent approval of an emergency order requiring the use of ultrasound during BBL surgeries to avoid injecting fat into the muscle and reduce the risk of fat embolisms. Also Read:… Continue reading Florida Plastic Surgeons Using New Clarius Wireless Ultrasound to Comply with Emergency Order Mandating Ultrasound Guidance for Safer BBL Procedures
Ascensia Diabetes Care Announces European Approval of the Next-Generation Eversense E3 Continuous Glucose Monitoring System
Ascensia Diabetes Care, a global diabetes care company, maker of CONTOUR® blood glucose monitoring (BGM) system portfolio and distributor of Eversense® Continuous Glucose Monitoring (CGM) Systems, announces that its partner Senseonics Holdings, Inc. has received CE Mark approval for the Eversense® E3 Continuous Glucose Monitoring (CGM) System, clearing the way for its use in European… Continue reading Ascensia Diabetes Care Announces European Approval of the Next-Generation Eversense E3 Continuous Glucose Monitoring System