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
Devices
A 2/6 CDRH Warning Letter to ExThera Medical Corp. said the company distributed unapproved devices to hospitals without obtaining FDA approval to do so under its open IDE. Writing in an online post, Mintz attorneys Joanna Hawana and Benjamin Zegarelli say ExThera is the sponsor of certain clinical research
Devices
FDA approved a LivaNova PMA for its aura6000 System, a novel implantable device designed to treat adults with moderate to severe obstructive sleep apnea. The device uses proximal hypoglossal nerve stimulation, a neurostimulation approach that activates muscles controlling the airway to prevent obstruction during sleep, according to the company. LivaNova
Devices
A 2/19-3/11/2025 FDA inspection at Avertix Medical in Eatontown, NJ, found multiple violations in the firm’s manufacture of The Guardian System, an implantable coronary syndrome event detector. A just-released nine-page 9/3/2025 Warning Letter lists these Quality System Regulation violations: * failure to
Devices
Minutes from the 2/11 and 2/18 MDUFA 6 negotiating sessions between FDA and industry representatives indicate agreement was reached on several issues, with others needing further discussion. The 2/18 minutes say the two sides have agreed to proposals on patient science, digital health, third-party 510(k)
Devices
FDA has issued an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet, citing risks of improper insulin delivery. The alert applies to specific lots of the company’s Omnipod 5 Pods, a tubeless insulin delivery system used by people with diabetes. The FDA
Devices
Integra LifeSciences has recalled certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component used during procedures to monitor brain pressure. The recall affects specific lots of the Codman Microsensor Basic Kit and Cerelink ICP Sensor Basic Kit, devices commonly used to measure intracranial pressure in patients
Devices
Insulet has initiated a Class 1 device correction for certain lots of its Omnipod 5 Automated Insulin Delivery System pods after identifying a manufacturing issue that could affect insulin delivery, according to an FDA notice. Some pods from specific lots may contain a small tear in the internal tubing used
Devices
FDA has approved Johnson & Johnson’s Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens for use in cataract surgery, giving surgeons a new option designed to improve visual range while maintaining strong visual quality. According to Johnson & Johnson, the lens is the first FDA-approved
Devices
FDA has released a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations outlining recommendations for companies developing devices intended to support weight management or weight loss, and detailing the types of information manufacturers should include in premarket submissions. The guidance applies to several categories of