Category:
FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
CurvaFix Receives FDA Clearance for Smaller-diameter, Intramedullary Implant for Pelvic Fracture Fixation
“With this latest FDA clearance, we are able to offer surgeons CurvaFix Implant in two diameters, 7.5mm and 9.5mm, and in lengths ranging from 90mm to 180mm,” said Steve Dimmer, CurvaFix chief executive officer.
FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic)....
NeuroOne® Receives FDA 510(k) Clearance to Market its Evo® sEEG System for Less than 30 Day Use
Evo® sEEG System epresents the Company's second FDA 510(k) cleared product. NeuroOne now provides a full line of electrode technology to address an estimated worldwide market of $100 million for patients requiring diagnostic brain mapping procedures.
MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval
SELUTION SLR is commercially available in Europe, Asia, the Middle East and the Americas (outside USA) and most other countries where the CE Mark is recognized. Over 10,000 units have already been used for patient treatment in routine clinical practice or as part of clinical trials.
Sol-Millennium Receives FDA Clearance for Sol-Guard Safety Pull Button Blood Collection Set
The Sol-Guard® Safety Pull Button Blood Collection Set features spring-activated needle retraction technology, designed to minimize the risk of accidental needlesticks and exposure to blood-borne pathogens.
Medtronic First to Receive FDA Approval for Pacing the Heart’s Natural Conduction System
Commonly referred to as "conduction system pacing," this approach helps ensure that pacing closely mimics the heart's physiologic contractions, allowing the heart's ventricles to work in coordination.
XACT Robotics ® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit
“The XACT ACE Robotic System has already allowed users to make percutaneous procedures, such as ablations, drainages and biopsies, more accurate, consistent and efficient,” said Shai Meltzer, CEO of XACT Robotics.
New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials
The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices.
iMediSync Announces ‘iSyncWave’ EEG Scanner Receives FDA 510k clearance
According to iMediSync, iSyncWave is a dry EEG scanner that does not require the use of electrode gel. It is not only easy to wear the device and measure EEG, but the size of the device can also be adjusted to accommodate various head shapes and align with the internationally standardized 10-20 system.
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