GlobalData on MSN20h
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 ...
Business Wire4d
FDA Reauthorizes Swedish Match’s General snus as a Modified Risk Tobacco Product
The U.S. Food and Drug Administration has authorized versions of IQOS electronically heated tobacco devices and Swedish Match’s General snus as modified risk tobacco products. Renewal applications for ...
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: ...
US FDA approves Johnson & Johnson's device for heart condition
The U.S. Food & Drug Administration has approved Johnson & Johnson's device for a type of condition which causes abnormal ...
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) -- ...
health.economictimes.indiatimes21d
NovoCure’s wearable device receives FDA approval for metastatic cancer treatment
New Delhi: NovoCure, a US-based company, recently received FDA approval for its wearable device to treat metastatic cancer using Tumor Treating Fields (TTFields) technology. This non-invasive ...
MD&M East23d
How different are the EU & FDA medical device regulations?
Examining the evolving dynamics between EU and FDA regulations for medical devices. The webinar will address the historical practice of obtaining a CE Mark in Europe first, contrasting it with the ...
JD Supra23d
FDA Announces New Director of the Center for Devices and Radiological Health
Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological ...
MassDevice23d
FDA approves Medtronic’s Affera cardiac mapping and ablation system and Sphere-9 catheter
The Affera mapping and ablation system with the Sphere-9 catheter [Images courtesy of Medtronic] Medtronic (NYSE:MDT) today said it received FDA approval ... in the U.S. as devices launch and ...
Medical Xpress24d
FDA approves Vyalev for advanced Parkinson's disease
The U.S. Food and Drug Administration has approved AbbVie's Vyalev (foscarbidopa and foslevodopa) for adults living with advanced Parkinson's disease (PD). Vyalev is the first and only ...
Reuters24d
US FDA approves Pfizer's RSV vaccine for adults at increased risk of the disease
Oct 22 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Pfizer's (PFE.N), opens new tab RSV vaccine for the prevention of lower respiratory tract disease caused by RSV in ...