Devices
The CDRH 2022 Annual Report shows that the Center granted marketing authorization for 19 submissions that were designated as breakthrough devices. The report also shows that 84 novel devices received marketing authorizations and there were 135 submissions designated as breakthrough devices. In terms of safety-related communications, CDRH was involved
Devices
The U.S. Justice Department has charged 12 dental practices and alleged accomplices in the Eastern Pennsylvania federal court with defrauding FDA, Medicaid, U.S. Immigration authorities, and the IRS, as well as laundering the fraud proceeds. Three of the defendants allegedly conspired to place adulterated and misbranded dental devices
Devices
Datascope/Getinge has recalled its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) due to the risk of blood entering the pumps through a damaged balloon catheter. According to a recall notice, blood entering the pump could cause an unexpected shutdown, which could lead to organ damage or death.
Devices
AdvaMed says it appreciates a proposed update to the EPA emissions standards for facilities using ethylene oxide (EtO) to sterilize medical devices and offers points for the Biden Administration to consider as it finalizes the regulation. In a letter to President Joseph Biden, AdvaMed asks the administration to: * consider the
Devices
Intense lobbying on behalf of laboratory-developed test (LDT) makers, professional associations, and academic medical centers led Congress to reject the inclusion of the VALID (Verifying Accurate Leading-edge IVCT Development) Act in the omnibus spending bill that was approved at the end of 2022, according to a ProPublica analysis.
Devices
A 1/20 citizen petition submitted by the Service Employees International Union — United Healthcare Workers West calls on FDA to issue a “corrective recall” requiring modifications to specific hemodialysis machines manufactured by Fresenius USA. The petition asks that FDA require: * a modification to include an ultrafiltration settings screen that calculates
Devices
FDA has cleared a Tidepool 510(k) for its Tidepool Loop, an automated insulin dosing app intended for managing Type 1 diabetes in patients aged six years and older. Tidepool Loop is described by the company as a patient-led project that allows insulin delivery from a compatible Apple Watch.
Devices
A citizen petition submitted 1/22 by Soft Lights Foundation asks FDA to issue regulations under 21 CFR Part 1040.41 to “regulate electromagnetic radiation in the visible portion of the spectrum emitted by products that use light-emitting diodes that pulse, flash, or strobe, and that these regulations set
Devices
Medtronic has updated a 2022 recall of its HeartWare Ventricular Assist Device System batteries and is now requesting the return of 12 batteries for ongoing engineering analysis due to a potential weld nonconformance. The company says recent actions have been taken to improve control of the welding process after two
Devices
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)).” Agency regulations authorize FDA to require: (1) manufacturers to report medical device-related deaths, serious injuries, and malfunctions and (2) user facilities to report device-related
Drugs
House Energy and Commerce Committee ranking member Frank Pallone (D-NJ) has written to FDA and the National Institutes of Health (NIH) with a concern about the “lack of compliance by medical product sponsors with requirements to report certain clinical trial results information to the ClinicalTrials.gov database.” His 1/
Devices
FDA says a Surmodics PMA application for its SurVeil drug-coated balloon is currently not approvable. A company statement says the agency provided guidance for a path forward, indicating that certain biocompatibility and labeling information should be added to the PMA through an amendment to place it in an approvable
Devices
FDA says it is amending and repealing parts of the radiological health regulations covering 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. The final rule says
Devices
FDA has cleared a Realize Medical 510(k) for its Elucis virtual reality software for surgical planning. The device is intended to aid medical professionals to quickly create, understand, and share complex patient anatomy from CT and MRI scans in an “immersive” 3D environment, the company says. The virtual collaboration
Drugs
FDA commissioner Robert Califf says a major reformation of our national system for generating medical evidence — the clinical research enterprise — is needed to facilitate the translation of biomedical research into useful products and interventions. Writing in the journal Clinical Trials, Califf says that currently premarket systems for generating and evaluating
Devices
FDA says it has opened a public docket to receive stakeholder comments on the question of how the agency should use MDUFA 5 user fee funding that may be distributed to an external organization other than the National Evaluation System for Health Technology (NEST). An agency notice says the comment
Devices
FDA has approved Abbott’s latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, for treating people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. Aortic stenosis is the narrowing of the aortic valve’s opening, which restricts blood flow to the body.
Devices
Medtronic’s Coviden unit has recalled its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a “potential leaking condition within the hub of affected devices,” according to a recall notice. The leaking is due to an inter-lumen void in the hub component, which may result
Devices
Kambiz Youabian (Tarzana, CA) has pleaded guilty to a two-count information charging him with mail fraud and introducing misbranded medical devices into interstate commerce. The government says Youabian operated an almost $6 million scheme in which he knowingly sold used skin-tightening medical devices that were deliberately misbranded as
Devices
FDA says it is making minor updates to two Covid-19 testing guidances to help ensure continued access to tests while encouraging the transition of the tests to traditional premarket review pathways. An agency notice says the two affected guidances are Policy for Coronavirus Disease-2019 Tests (Revised) and Policy
Devices
CDRH Office of Strategic Partnerships and Technology Innovation director Suzanne Schwartz says the agency is working to implement provisions in the recently-approved omnibus spending bill giving FDA authority to require medical device manufacturers to address cybersecurity issues. In an online interview with HealthcareInfoSecurity, Schwartz said the agency has spent
Devices
Researchers from three academic medical centers say the National Committee on Vital and Health Statistics (NCVHS) should approve a proposal to modify health service claims forms to include medical device unique device identifiers (UDIs). Writing in a BMJ opinion piece, the researchers say medical device safety in the U.S.