Devices
FDA has approved SetPoint Medical’s SetPoint System, a first-of-its-kind neuroimmune modulation device to treat adults with moderate to severe rheumatoid arthritis who are not adequately managed by, or can’t tolerate, existing advanced therapies such as biological and targeted synthetic disease-modifying anti-rheumatic drugs. A
Devices
FDA has cleared a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals. These signals are intended to offer clinicians a more complete picture of heart function, including insights into cardiac mechanics, blood flow, and hemodynamics, according
Devices
FDA has published a guidance, Medical Device User Fee Small Business Qualification and Determination, describing the process for how a business may request a determination that it qualifies as a small business for the purpose MDUFA provisions about reduced fees for such businesses. The document says that a business that
Devices
A 2/4-4/4 FDA inspection at Onkos Surgical in Parsippany, NJ, determined that the firm is a specification developer of the ELEOS Limb Salvage System, indicated for use in total knee and hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature
Devices
FDA has cleared a Stereotaxis 510(k) for its MAGiC Sweep catheter, which it describes as the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter for diagnosing and treating complex arrhythmia patients. “High density mapping has transformed the EP field, enhancing cardiac ablation procedures by enabling more
Devices
Ethicon Endo-Surgery is recalling (Class 1 device correction) its Echelon Flex Powered Vascular Stapler to correct the product’s inadvertent lockout during surgical procedures. The device will momentarily activate but will not cut or staple tissue, a recall notice says. “Additional steps will be required to open it and
Devices
Medline Industries is recalling (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm. Integra LifeSciences has recalled the perforators due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure, a recall
FDA Policy/General
Former and current FDA employees who have used the agency’s new internal generative artificial intelligence (AI) tool Elsa report that it can’t be trusted. An online Gizmodo post says three employees told CNN that Elsa makes up nonexistent studies, something commonly referred to in AI as “hallucinating.” The
Devices
Baxter Healthcare has recalled (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attachment. The company says that the Q-link 13 component could allow for false latching of the quick-release hook used on sling bars and other accessories. “The
Devices
FDA has issued an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump, following reports of underinfusion, overinfusion, and two patient deaths. According to Baxter, the device may deliver insufficient medication or fluids when transitioning from a lower to a significantly higher flow
Biologics
An 8/23-8/31/2023 FDA inspection at the O3UV facility in Grand Ledge, MI, documented multiple violations in the firm’s illegal manufacturing of autohemotherapy devices. A 7/7 Warning Letter says the firm’s products are adulterated because the company does not have an approved PMA or
Devices
Maquet Critical Care AB, a subsidiary of Getinge, is recalling (Class 1 device correction) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients. The devices can be used with several different patient circuits
Devices
Integra LifeSciences is recalling (Class 1) its MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilization location transfer documentation, both of which help ensure the products were adequately sterilized. “The use of affected product may cause serious adverse health consequences, including inflammation, infection, and death,” a recall notice says.
Devices
SunMed Holdings is recalling (Class 1) its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter. “The use of affected product may cause serious adverse health consequences, including lack of oxygen to the body (hypoxia), build-up of carbon dioxide in the blood (hypercapnia), organ failure,
FDA Policy/General
While FDA updates and improves its Elsa internal generative artificial intelligence (AI) tool, questions and concerns persist in the industry that FDA is potentially using a tool that might not have passed the agency’s own expectations for the validation, governance and transparency of such tools when used for FDA-
Devices
FDA says Whoop, Inc., Boston, MA, is marketing its Blood Pressure Insights (BPI) medical device without agency approval and despite agency assertions that Blood Pressure Insights is legally considered to be a medical device that requires premarket approval. A 7/14 Warning Letter says the firm’s Web site indicates
Devices
FDA has cleared a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operative guidance for transcatheter heart valve implantation. The device is intended to enhance implant procedure precision and improve patient outcomes, according to the company, adding that the
Devices
BD and subsidiary CareFusion have issued an “Urgent Medical Device Recall (Correction)” letter about performance issues, under certain use cases, for the BD Alaris Pump Module model 8100 when used with a subset of compatible pump infusion sets. “BD stated that they have identified a subset of compatible pump infusion
Devices
FDA has granted Artera a breakthrough device designation for its ArteraAI Prostate, an artificial intelligence-based tool designed to assist clinicians in personalizing treatment decisions for patients with localized prostate cancer. The company says the device’s software uses multimodal artificial intelligence to analyze digital pathology images from a patient’
Devices
AirLife is recalling certain lots of its Broselow Pediatric Emergency Rainbow Tape because they were manufactured with incorrect information on the tape. “Incorrect joules in the cardioversion and defibrillation section are printed in the red zone of the tape,” a recall notice says. “Using the incorrect information in this section
Devices
A University of Illinois law school scholar who specializes in the ethical and legal challenges of artificial intelligence (AI) for health care says FDA needs to develop labeling standards for AI-powered medical devices. A university news release says Sara Gerke suggests that the labeling follow the format of mandatory
Devices
The Foundation for Defense of Democracies (FDD) says that medical devices such as pacemakers, insulin pumps, and vital signs monitors that are already in use in healthcare settings are vulnerable to hacking despite a new FDA guidance. An FDD paper says the guidance doesn’t have a requirement that companies