DeGette, Brooks Ask FDA for Specifics on Device Cybersecurity
House Energy and Commerce Committee members Diana DeGette (D-Colo.) and Susan Brooks (R-Ind.) have asked the FDA to explain how it is addressing cybersecurity vulnerabilities in medical devices.
In a letter to FDA Commissioner Dr. Robert M. Califf and Director of the Center for Devices and Radiological Health Jeffrey Shuren, DeGette and Brooks inquired about the agency’s plans to further reduce risks of hacking, unauthorized access, and use of malware in medical devices.
The representatives requested a response by Dec. 16.
Kator Receives FDA Clearance for Knotless Suture Anchor System
Kator, subsidiary to Surgical Frontiers, has gained its second FDA 510(k) clearance for its Kator Suture Anchor System.
This new FDA clearance expands the system for use with 2mm wide high strength suture tape. Made from PEEK material, a single Kator Suture Anchor is FDA-cleared for use with up to 4 strands of #2 suture or up to 2 strands of 2mm wide suture tape.
EOS Imaging Receives FDA 510(k) Clearance for kneeEOS 3D Surgical Planning Software
EOS Imaging has received a 510(k) clearance to market kneeEOS software the U.S.
The kneeEOS online 3D planning software utilizes weight-bearing 3D images and data from the EOS system to provide an optimized surgical plan for Total Knee Arthroplasty.