CARMEL, Ind., Nov. 04, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company ...

MIDDLETON, Wis.--(BUSINESS WIRE)--Imbed Biosciences announces U.S. Food and Drug Administration 510(k) clearance to market Microlyte® Ag/Lidocaine, the first antimicrobial wound dressing to ...

NeurAxis leveraged its robust published data to receive this new indication. “We are excited to receive this new 510(k) clearance for IB-Stim, which expands the IB-Stim addressable market by roughly ...

Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) monitoring service for non-critical care patients FDA ...

“We are excited to receive this new 510(k) clearance for IB-Stim, which expands the IB-Stim addressable market by roughly 75%,” said Brian Carrico, President and Chief Executive Officer of ...

Former presidential candidate Robert F. Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire departments” within the Food ...

“We are excited by the news and congratulate our customer’s entire team on receiving FDA 510(k) clearance for their revolutionary robotic surgery system,” stated Dr. Joe Forkey, CEO of ...

Zio AT remains commercially available on the market to ship to customers in the United States, and product enhancements subject to this 510(k) clearance will be available in 2025. “This ...

“We are excited by the news and congratulate our customer’s entire team on receiving FDA 510(k) clearance for their revolutionary robotic surgery system,” stated Dr. Joe Forkey, CEO of Precision ...

--(BUSINESS WIRE)--Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ...

"We are pleased to have received this first 510(k) clearance in line with the sequence of how we submitted the first of two 510(k)s at the beginning of this year, and we look forward to hearing ...