Devices
FDA says it has published minor updates to two magnetic resonance (MR)-related guidances to harmonize them with the latest edition of relevant FDA-recognized consensus standards. An agency notice (contains links to the guidances) says the updated guidances provide FDA’s recommendations on testing and labeling that should be
Devices
CDRH says it plans to publish four final guidances and 20 draft guidances in Fiscal Year 2024. An online document shows that on the A list of prioritized guidances, there are three final guidance topics and 18 draft guidance topics. On the B list of guidances to be published as
Drugs
The Regulatory Affairs Professionals Society (RAPS) says FDA is on schedule to publish a draft guidance on diversity plans before the end of this year. The society’s Regulatory Focus post says the guidance will take into consideration the unique challenges of conducting medical device clinical trials, citing an agency
Devices
FDA has cleared a Hyperfine 510(k) for updated software for its portable magnetic resonance brain imaging system, the Swoop system. The artificial intelligence (AI)-based software —"brings image quality enhancements to the Swoop system’s diffusion-weighted imaging (DWI) sequence,” Hyperfine says, adding that it expands the device’
Devices
FDA has released a final guidance entitled “Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.” The document is intended to harmonize with the 4th edition of the FDA-recognized standard IEC 60601-2-33 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance
Devices
FDA has approved Medtronic’s next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pain, and severe spasticity. The device is described as a targeted drug delivery platform that alleviates symptoms by delivering medication directly to the fluid surrounding the spinal cord. “SynchroMed III is
Devices
FDA has granted ZKR Orthopedics a breakthrough device designation for its Lift implant technology, which is designed to decrease pain, improve function, and delay or eliminate the need for knee replacement. If granted marketing authorization, the company says Lift will “expand the continuum of care for patients suffering from later
Devices
FDA has granted HistoSonics a de novo marketing authorization for the Edison System, which the company says uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue, including tumors, at sub-cellular levels. Authorization was based on data from the #HOPE4LIVER Trials in
Devices
Sen. Richard Blumenthal (D-CT) is calling on the Justice Department to take action against Philips Respironics after a recent investigation by ProPublica and the Pittsburgh Post-Gazette revealed the company kept secret more than 3,700 complaints about its faulty CPAP breathing devices over the course of 11 years
Devices
FDA has cleared a Sanguina 510(k) for the AnemoCheck Home, a home-use hemoglobin test kit. The prescription-only test is designed for individuals with anemia due to nutritional deficiency (iron deficiency anemia, vitamin B12 deficiency anemia, and folate deficiency anemia), sickle cell disease, and thalassemia to monitor their
Devices
As part of Cybersecurity Awareness Month, CDRH is marking the 10th anniversary of its cybersecurity program with an online post highlighting ways in which the program has contributed to patient safety in the last decade. CDRH Office of Strategic Partnerships and Technology Innovation director Suzanne Schwartz says the activities were:
Devices
Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) say FDA’s recent action in issuing a proposed rule on laboratory-developed tests “recognizes the need for action in this space.” In a statement, the two say the way to ultimately ensure the analytical and clinical validity of tests
Biologics
The Reagan-Udall Foundation has published Strategies for Improving Public Understanding of FDA-Regulated Products, providing observations, potential strategies, and illustrative tactics for FDA to consider. A foundation announcement (contains links to the report and a virtual public meeting discussing the findings) says the strategies result from the foundation’s
Devices
CDRH director Jeffrey Shuren says FDA remains unsatisfied with the status of the Philips Respironics recall of ventilators, bilevel positive airway pressure machines and continuous positive airway pressure machines due to potential health risks of PE-PUR sound abatement foam. In an online post, Shuren says that although Philips undertook
Devices
Medtronic is warning healthcare professionals about stolen defective McGRATH MAC video laryngoscopes that have been offered for sale illegally by unauthorized third parties through various social media platforms. The affected products “did not pass Medtronic’s rigorous quality tests” and were designated for destruction, a company release says. “Medtronic is
Devices
Attorney and data scientist Bradley Thompson (Epstein Becker Green) says FDA shouldn’t be able to continue refusing to respond to citizen petitions, sometimes for years and years. In an online post, Thompson analyzes the amount of time it takes CDRH to reach final decisions on citizen petitions. Thompson says
Drugs
AdvaMedDx says an FDA 6/22 guidance on a pilot program for oncology drug products used with certain in vitro tests would have benefited from advance notice and opportunity to comment. The association’s 9/28 comment letter says FDA issued the pilot as an immediately-in-effect guidance, thus
Devices
“Power tends to corrupt and absolute power corrupts absolutely.” (Lord Acton in 1887) [Analysis by Jim Dickinson] Suppose you had a way of speeding your product through FDA’s approval process while slowing down your competitor’s similar product. That’s what some medical device companies – like some drug companies
Devices
FDA has cleared an Anumana 510(k) for ECG-AI LEF, an artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. The device was developed in partnership with Mayo Clinic, and it screens for LEF using data from a routine
Devices
Without any progress from Capitol Hill on a legislative solution to reign in laboratory-developed tests (LDTs), FDA is now plowing ahead under a proposed rule to increase its scrutiny of such tests that have grown in use and complexity over many years. “Through increased FDA oversight, the public, including
Devices
FDA has published a guidance, Antimicrobial Susceptibility Test (AST) System Devices — Updating Breakpoints in Device Labeling, with information about updating susceptibility test interpretive criteria (STIC) breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized
Devices
FDA has published a draft guidance, Electronic Submission Template for Medical Device De Novo Requests, to introduce de novo request submitters to the current resources and associated content developed and made publicly available to support de novo electronic submissions to the agency. The document says it “is intended to represent