Devices
O-Two Medical Technologies has recalled its e700, e600 and e500 Automatic Transport Ventilators because an improperly inserted screw in the ventilator screen may wear through the electrical insulation and create a short circuit that could lead the device to catch fire and injure the patient. “Fires in oxygen rich
Devices
FDA has cleared an Intellirod Spine de novo submission for its disposable spinal rod strain sensor, the LoadPro. The device clamps onto a standard 5.5mm rod for use in monitoring rod strain during kyphotic correction surgery. The initial clearance is for LoadPro with the Fortex pedicle screw system from
Devices
FDA is proposing to amend and repeal parts of the radiological health regulations on recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. A Federal Register 4/
Drugs
FDA commissioner Scott Gottlieb believes that the most “enduring” accomplishment at the agency during his almost two-year stint is CDER’s ongoing new drug approval process reform and changing the nature of the application process to move away from a paper-based submissions. In a 3/29 sit-down
Devices
FDA Commissioner Scott Gottlieb has reversed course on certain device summary reporting about adverse events that are hidden to the public and researchers, and now says the agency will make such reports received prior to 2017 more easily accessible. “I think that the imperative of the agency is to make
Devices
FDA has cleared a Hitachi Chemical Diagnostics 510(k) for its new high capacity allergy testing instrument, Optigen AP 3600. The device delivers increased throughput and “true walk-away time” compared with its current device, the company says, adding that it can process up to 100 panels, or as many
Devices
DC federal court chief judge Beryl Howell says both FDA and the Judge Rotenbergng Educational Center (JRC) have fallen short in their arguments in a complex Freedom of Information Act (FOIA) case on the agency’s decision to propose a rule to ban use of the Graduated Electronic Decelerator, an
Devices
FDA has cleared a MiRus 510(k) for the MoRe-based Europa Pedicle Screw System, which the company says is the first cleared medical device with this new class of implant material. MoRe is characterized as a proprietary molybdenum rhenium superalloy for medical implants. The material “allows for the design
Devices
FDA has cleared an Innovative Neurological Devices 510(k) for the Cervella Cranial Electrotherapy Stimulator for treating anxiety, depression, and insomnia. The device works by delivering micro pulses of electrical current across a patient’s brain. The company says that clinical studies have demonstrated that the electrical stimulation results in
Devices
For the first time in over 20 years of regulating mammography facilities, FDA is proposing amendments to regulations to help improve the quality of mammography services. An agency news release says the changes would “expand the information mammography facilities must provide to patients and healthcare professionals, allowing for more informed
Devices
A 3/14 CDRH Webinar discussed the 2/5 final guidance on concepts and principles of the “least burdensome” regulatory information provisions. CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein said the guidance describes the agency’s use of the least burdensome approach through medical device regulation to remove
Devices
Public Citizen Health Research Group founder and senior advisor Sidney Wolfe says FDA should require extensive pre-approval testing of permanent implantable devices, including breast implants. Addressing the agency’s General and Plastic Surgery Device Panel 3/26, Wolfe said breast implants have caused many serious medical conditions in women,
Devices
FDA has cleared a Masimo 510(k) for the Rad-67 Pulse CO-Oximeter with Spot-check Next Generation SpHb monitoring technology and the rainbow DCI-mini Reusable Sensor. Rad-67 offers hemoglobin measurement (SpHb) and Measure-through Motion and Low Perfusion SET pulse oximetry, the company says. The device
Devices
FDA commissioner Scott Gottlieb says the agency is taking steps to prevent and mitigate potential medical device shortages due to the recent closure of an Illinois sterilization facility and the likely closure of a second facility. In a statement, Gottlieb says FDA has been monitoring the situation following action by
Devices
FDA has cleared a SpineEX 510(k) for its Sagittae Lateral Lumbar Interbody (LLIF) Fusion System. The company describes the device as a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It allows for up
Devices
FDA has cleared a BrightWater Medical 510(k) for the ConvertX Biliary Stent System for treating biliary obstructions. The company describes the device as the first system to provide interventional radiologists with a percutaneous plastic biliary stent option. It is designed to eliminate the need for a second invasive procedure.
Devices
FDA has cleared a Zimmer Biomet 510(k) for the Rosa One Spine System for robotically assisted spine surgeries. The device combines robotics and navigation “while delivering a unique real-time patient dynamic tracking capability,” the company says. “The platform features 3D intraoperative planning software in addition to a navigation
Devices
FDA has cleared a Genetesis 510(k) for its cardiac imaging platform, which pairs its CardioFlux Magnetocardiograph with the integrated Faraday Analytical Cloud (FAC). The company says the new technology provides emergency room physicians and cardiologists with access to measure and visualize magnetic fields produced by the heart’s natural
Devices
FDA has cleared a GenePOC 510(k) for the GenePOC Strep A assay for use on its revogene device. The qualitative in vitro diagnostic test is intended for detecting Streptococcus pyogenes nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The assay can provide
Devices
FDA has approved an Impulse Dynamics PMA for the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. The device comprises
Devices
Soliton has submitted a 510(k) for the Rapid Acoustic Pulse (RAP) tattoo removal device. The device is indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. The company says
Devices
Symantec says the current iteration of an FDA draft guidance on content of premarket submissions for managing cybersecurity in medical devices has “significant improvements over the previous version and helps align stakeholders to the shared mission of providing a more secure and safer healthcare system.” In a comment letter, the