Devices
FDA has cleared a Philips 510(k) for its new Spectral CT Verida system, marking the U.S. debut of what the company describes as the first AI-powered detector-based spectral CT scanner. The device integrates always-on spectral imaging with artificial intelligence – driven image reconstruction, aiming to improve
Devices
AdvaMed says it supports FDA’s effort to implement the 21st Century Cures Act by appropriately expanding exemptions from premarket notification for Class 2 devices where a 510(k) submission is not necessary to provide reasonable assurance of safety and effectiveness. In a comment letter, the industry trade association: * says
Devices
A 4/1 CDRH Town Hall reviewed the new Quality Management System Regulation (QSMR) and its associated Compliance Program for medical device risk-based inspections. Office of Medical Devices and Radiological Health Inspectorate senior advisor Karen Masley-Joseph described the QMSR program that became effective 2/2. She said the
Devices
While many elements of QMSR (Quality Management System Regulation) inspections will feel familiar, the shift as of the 2/2 compliance date toward evaluating the entire Quality Management System (QMS), the increased emphasis on risk management integration, and the broader discretion afforded to investigators “represent meaningful changes that manufacturers should
Devices
FDA has issued an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical, warning healthcare providers to stop using the devices and return affected products. Sizing catheters are commonly used in angiographic procedures to help clinicians measure and navigate blood vessels. The agency says
Devices
FDA and the medical device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations, according to a MedTech Dive report. Both sides have reached an “agreement in principle” on most elements of the deal and are now working to finalize
Devices
Medline Industries has recalled (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death. The recall affects Namic Angiographic Rotating Adaptor Control Syringes and related convenience kits, which are used to deliver contrast media during imaging procedures. The company has instructed customers to immediately remove
Devices
A 12/1-12/12/2025 FDA inspection at the Medline Industries NAMIC Division facility in Glens Falls, NY, found Quality System Regulation violations in the firm’s manufacturing and assembly of numerous medical devices into cardiovascular procedure kits. A 3/25 Warning Letter says the specific violations were: * failure
Devices
FDA has opened the selection phase of its Reducing Readmissions through Device Innovation for the Home (READI-Home) innovation challenge, which is intended to accelerate patient access to medical device technologies aimed at reducing hospital readmissions. An agency post invites innovators to pursue potential participation in the challenge by providing
Devices
FDA has cleared an Anumana 510(k) for an artificial intelligence–based tool designed to detect early signs of pulmonary hypertension, a serious and often underdiagnosed cardiovascular condition. The company’s software-as-a-medical-device algorithm is intended to analyze standard 12-lead electrocardiograms (ECGs) to identify subtle indicators
Devices
FDA’s updated guidance on incorporating patient preference information (PPI) into regulatory decision-making for medical devices and biologics signals a constructive shift for the 510(k) pathway. By explicitly acknowledging the relevance of PPI in these submissions, the agency is opening the door to a more patient-centered evidentiary
Devices
FDA says it is “redoubling efforts to utilize real-world evidence (RWE) across a wider range of medical devices to support timely access to safe and effective technologies, foster innovation, and strengthen the foundation of regulatory decision-making.” To that end, the agency has published a new set of 73
Devices
FDA has denied a 2025 petition that asked the agency to exempt specific radiology computer-aided detection and/or diagnosis (CAD) devices and computer-aided triage and notification devices (CADt) from 510(k) requirements. The agency denial letter says the petition asked for exemption from the premarket notification requirements for
Devices
A 4/29-6/18/2025 FDA inspection at the Physitemp Instruments facility in Clifton, NJ, found multiple violations in the firm’s manufacturing of clinical electronic thermometers, clinical temperature monitoring probes, and a needle microprobe. A just-released 11/12/2025 Warning Letter said specific Quality System Regulation violations
Devices
FDA has issued a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle. The document was mandated under the medical device user fee program to provide insight and address common questions for those interested in the voluntary use of PPI in regulatory submissions. The
Devices
FDA has cleared a Medtronic 510(k) for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures, extending the reach of a platform the company is positioning as a unified navigation and robotics hub across surgical specialties. The latest clearance follows an earlier nod for spine
Devices
Erbe USA has recalled (Class 1) its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury or death. To date, there have been five serious injuries linked to the malfunction, FDA says. According to Erbe USA, the issue stems from insufficient adhesive applied
FDA Policy/General
University of Southern California Price School of Public Policy associate professor Genevieve Kanter says policymakers should consider conflict of interest policies to be part of a broader strategy of building public trust by being more trustworthy as an agency. “This includes providing comprehensive scientific justification for decisions, being transparent about
Drugs
The National Association of Manufacturers (NAM) is petitioning FDA to follow the statutory and regulatory procedures governing advisory committees under regulations and the Federal Advisory Committee Act “to allow for mandatory and all other stakeholders to comment on current and upcoming regulatory policies and procedures that FDA is discussing during
Devices
A 10/20-10/30/2025 FDA inspection at Longhorn Vaccines and Diagnostics in Bethesda, MD, found multiple violations in the firm’s work as a specification developer of the PrimeStore MTM (molecular transport medium) device intended for the stabilization, transportation, and inactivation of infectious unprocessed nasal washes suspected of
Devices
Manufacturers developing weight-loss devices should carefully review FDA’s 3/2026 final guidance closely, particularly the effectiveness thresholds, adverse event grading system, and evaluation matrices that will shape pivotal study design and premarket strategy. That’s the recommendation of Hogan Lovells attorneys Kristin Duggan and Megana Sarkaran, writing in
Devices
A 10/6-10/17/2025 FDA inspection at the IsoTis OrthoBiologics facility in Irvine, CA, found Quality System Regulation violations in the firm’s manufacturing of resorbable calcium salt bone void filler devices branded under the Accell family of products. A just-released 2/24 Warning Letter says the