FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today announced the U.S. Food and Drug ...
GlobalData on MSN18h
OMRON receives FDA authorisation for blood pressure monitors with AFib feature
OMRON Healthcare has secured De Novo authorisation from the US Food and Drug Administration (FDA) for new home blood pressure ...
Becker's Spine Review8d
5 FDA alerts, recalls to know
Here are five FDA alerts and recalls from 2024 for orthopedic and spine specialists to know: ...
TMCnet2d
Revolutionizing Heart Health: Frontier X Plus Gains FDA Clearance
Fourth Frontier, a medical technology company based out of New York and Bangalore, announced the 510(k) clearance of the ...
The Lancet1d
Building robust, proportionate, and timely approaches to regulation and evaluation of digital mental health technologies
Demand for mental health services exceeds available resources globally, and access to diagnosis and evidence-based treatment ...
Novabone Secures FDA Clearance For Expanded Indications Of Putty In Interbody Fusion Applications
ALACHUA, FL, UNITED STATES, November 12, 2024 /EINPresswire / -- NovaBone Products, a leader in synthetic bone graft solutions, has ann ...
Elutia Inc. Reports Strong Q3 Results, Prepares for Major Product Launch
Aziyo Biologics, Inc. Class A ( (ELUT) ) has released its Q3 earnings. Here is a breakdown of the information Aziyo Biologics, Inc. Class A ...
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
Yahoo Finance8d
FDA Inspection Preparedness and Compliance Seminar (ONLINE EVENT: December 3-4, 2024/ON-DEMAND)
This is a practical, hands-on two-day seminar designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals ... to prepare for and survive an FDA inspection no ...
Catheter Precision, Inc. Announces Initial LockeT Purchase From Montefiore Medical Center
Catheter Precision, Inc. (NYSE American:VTAK), a U.S.-based innovative medical device company focused on electrophysiology products, today announced it has received its first purchase order for LockeT ...
What's behind the increase in food recalls? Why recalls are rising and what you can do
A wave of food recalls linked to outbreaks of salmonella or E. coli may have you on alert. Recently dozens of people were ...
Unauthorized online ads as if they were licensed for medical devices...155 cases detected.
A number of online unfair advertisements have been caught, such as misleading general industrial products as medical devices.The Ministry of Food and Drug ...