fetal monitoring News
-
MindChild Medical, Inc. Announces ISO 13485 Approval
(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received ISO 13485:2003 certification for the design, development and manufacturing of its MERIDIAN family of non-invasive Fetal Monitors1,2,3,4 . ISO 13485:2003 certification precedes European pre-market submission of a Technical File submission5 , enabling European commercialization of the MERIDAN ...
-
MindChild Medical, Inc. Announces filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the MERIDIAN™ M110 Line of Non- Invasive Fetal Heart Rate Monitors
(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has filed a 510(k) pre-market notification with the US Food and Drug Administration (FDA) for its MERIDIAN Model M110 non-invasive Fetal Heart Monitor1,2,3 . MindChild previously announced 510(k) pre-market clearance of the MERIDIAN M100 fetal monitor. MindChild anticipates entering the US market with ...
-
MindChild Medical Announces an Exclusive Distribution and Supply Agreement with Henry Schein Medical
MELVILLE, N.Y., April 25, 2019 – Henry Schein Medical, the U.S. Medical business of Henry Schein, Inc., and MindChild Medical, Inc. today announced the signing of an exclusive distribution and supply agreement for the MERIDIAN™ M110 Fetal Monitoring System. The MERIDIAN M110, currently available to Henry Schein customers, is an intrapartum fetal monitor that externally measures and ...
-
MindChild Medical Inc. Announces FDA 510(k) Clearance for MERIDIAN M100 Monitor
(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received clearance for a 510(k)Pre-Marketing Notification Application from the US Food and Drug Administration (FDA) for its MERIDIAN Model M100 non-invasive Fetal Heart Monitor1,2. MindChild anticipates entering the US market with MERIDIAN following the FDA pre-market clearance. Additional ...
-
MindChild Medical, Inc. Announces FDA Clearance for M110 Monitor
(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received clearance for its Pre-Marketing Notification (510(k)) from the US Food and Drug Administration (FDA) for its MERIDIAN™ M110 non-invasive fetal heart monitor. MindChild anticipates entering the US market with MERIDIAN now that it has received the FDA clearance. ...
-
MindChild Medical, Inc. Announces Gates Funded UNC LABOR Study Enrolls 6,000th Subject Recorded with Meridian™ Fetal ECG Research Device
The Meridian Fetal Research Device Accurately Extracts Fetal ECG to Enable Analytics on Fetal ECG Morphology, Heart Rate, Heart Rate Variability and Uterine Activity Using Surface Electrodes (North Andover, Massachusetts), Mindchild Medical, Inc. announced that the LABOR study recorded its 6,000th subject with MindChild’s Meridian Fetal Research Device. Jay Ward, MindChild Medical’s ...
-
Study Finds K2 Infant® Software Halves Poor Birth Outcomes At Australia’S Largest Maternity Service
04 August, 2021, Plymouth, UK: K2 Medical Systems (K2), a UK-based company providing specialised maternity software solutions and business unit of Harris, welcomes the publication of a paper detailing a recent study undertaken at Mater Mothers’ hospital Brisbane, Australia using the K2 INFANT-Guardian® (INFANT) system. (https://www.k2ms.com/blog/2020/mater-mothers-infant-paper.aspx) ...
-
MindChild Medical, Inc. Announces Gates Funded UNC LABOR Study Selects Meridian™ Fetal ECG Research Device for Its Unparalleled Fetal ECG Capabilities
(North Andover, Massachusetts), MindChild Medical, Inc. today announced that the LABOR Study selected MindChild’s Meridian Fetal Research Device as the centerpiece of their study due to its unparalleled ability to accurately extract fetal ECG for advanced analytical research. Dr. Jeffrey Stringer, professor of obstetrics & gynecology in the UNC School of Medicine and LABOR Study ...
-
Perinatal Safety Company PeriGen, Inc., Acquired by Halma plc, a Global Group of Life Saving Technology Companies
PeriGen, Inc., the market leader in applying artificial intelligence (AI) to improve safety in childbirth, today announced it has been acquired by Halma plc. Based in the UK, Halma is a FTSE 100 global group of life-saving technology companies that provide innovative solutions to many of the key problems facing the world today – such as avoidable adverse events in childbirth. Halma’s ...
-
Beazley and PeriGen to Collaborate on Patient Safety Programs Addressing Obstetric Safety
PeriGen, the global leader in developing artificial intelligence (AI) systems for obstetrics, has partnered with specialist insurer Beazley to offer its safety-based obstetric program to Beazley’s healthcare clients in the United States. Under the arrangement, Beazley will facilitate distribution of PeriGen’s AI-powered early warning system for labor and delivery, PeriWatch ...
-
Sydney MedTech Baymatob completes capital raise to advance life-saving labour monitoring device
Sydney medical device company Baymatob has completed a placement of $4.215 million, with proceeds used to continue in-human clinical trials for its AI-guided labour monitoring device, Oli. Cornerstoned by Australian Unity’s Future of Healthcare Fund, the placement was strongly supported by Australian institutional and high net worth investors, securing long-term capital partners to support ...
-
Texas Children’s Pavilion for Women Teams up With PeriGen to Bring PeriWatch Vigilance® to Malawi
Texas Children’s Pavilion for Women® announced today the launch of the PeriWatch Vigilance® program in Lilongwe, Malawi (in southern Africa), in partnership with PeriGen Advanced Perinatal Software, a provider of innovative software solutions for over 20 years with a mission to protect mothers and babies everywhere. In a public-private partnership with the Texas Children’s ...
-
IronHealth Enters into Preferred Partnership with PeriGen to Advance Obstetrics AI Technology
IronHealth, the healthcare professional liability and stop loss unit of Ironshore, has entered into a preferred partnership with PeriGen, a perinatal software solutions provider, offering insureds access to leading-edge obstetrics artificial intelligence systems. PeriGen’s FDA-cleared artificial intelligence (AI) tools help clinicians identify continuous clinical warning signs in ...
-
PeriGen Deploys Mobile Version of PeriWatch Vigilance to Further Protect Moms and Babies During Childbirth
PeriGen Inc., the market leader in applying artificial intelligence (AI) to improve safety in childbirth, today introduced PeriWatch Vigilance® Mobile, a full-function browser-based solution providing access to its early warning system (EWS) and clinical decision support tool. By providing remote access to the full range of conditions monitored by PeriWatch Vigilance, the new solution ...
-
SCL Health to Deploy System-Wide OB Hub Powered by PeriWatch Command Center
PeriGen Inc., the market leader in applying artificial intelligence (AI) to improve safety in childbirth, today announced that SCL Health, a health system operating eight hospitals and 150 clinics in Colorado and Montana, is launching a centralized SCL Health OB Hub utilizing PeriGen’s PeriWatch Command Center enterprise-wide telehealth-platform. Through the OB Hub, a dedicated team of ...
-
Santa Barbara Cottage Hospital Enhances Maternal and Fetal Safety with Go-Live of PeriGen’s PeriWatch Vigilance
PeriGen®, an innovator in perinatal early warning systems, today announced that Santa Barbara Cottage Hospital, a 519-bed acute care teaching hospital and trauma center that is part of the not-for-profit Cottage Health system, is now using PeriGen’s PeriWatch Vigilance® automated maternal-fetal early warning system (EWS) in its labor and delivery (L&D) department. Founded in ...
-
HealthTech Arkansas names five early-stage companies for latest cohort
HealthTech Arkansas announced the five early-stage companies selected for the 2020 HealthTech Arkansas healthcare accelerator. The accelerator is supported by 11 Arkansas healthcare organizations, including Arkansas Children’s Hospital, Arkansas Heart Hospital, Arkansas Urology, Baptist Health, CHI St. Vincent, Conway Regional Health System, Mercy, OrthoArkansas, St. Bernards Healthcare, ...
By Zeto, Inc.
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you