Devices
FDA is cautioning health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices following reports of serious injuries and deaths tied to their use. In a recent safety communication, the agency urges providers to strictly follow manufacturers’ instructions and to reinforce fire prevention measures when
Devices
AdvaMed and other device stakeholders are urging the Centers for Medicare & Medicaid Services (CMS) to overhaul how it covers new device technologies, warning that patients are waiting years too long for access to innovations approved and cleared by FDA. In a recent letter to CMS administrator Mehmet Oz, the
Devices
FDA has cleared a Signos 510(k) for what the company says is the first over-the-counter glucose monitoring system designed specifically for weight management. The device pairs Dexcom’s Stelo glucose biosensor with Signos’ artificial intelligence-driven platform to provide consumers real-time insights into how diet, exercise,
Devices
Researchers from several academic medical centers say that only half of artificial intelligence (AI)- and machine learning (ML)-enabled devices authorized by FDA for Alzheimer’s disease and related dementias (ADRD) have demographic details reported for their training or validation datasets. Writing in a JAMA Research Letter, the authors say
Devices
FDA has published a guidance, Animal Studies for Dental Bone Grafting Material Devices, with 510(k) recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices. The document says the recommendations reflect current practices and are intended to promote consistency
Devices
FDA has issued enVVeno Medical a not-approvable letter for its PMA on VenoValve, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI). The agency concluded that data submitted from the SAVVE study were insufficient to establish a favorable benefit-risk profile, the company says.
Devices
Since its 2015 inception, the FDA Breakthrough Devices program has granted 1,176 breakthrough device designations, 1,157 from CDRH and 19 from CBER. Updated program metrics also show that the agency has granted 160 marketing authorizations since 2015.
Devices
FDA has suggested possible ways forward for CytoSorbents’ DrugSorb-ATR after denying the company’s appeal of the agency’s 4/25 denial of a de novo application for the antithrombotic removal system. In denying the appeal, FDA said it found no issues with device safety, a company statement says,
Devices
FDA has published a guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, recommending that such a plan describe the planned artificial intelligence-enabled device software function (AI-DSF) modifications, the associated methodology to develop, validate, and implement those modifications, and an
Devices
FDA has cleared a NeuroOne Medical Technologies 510(k) to market its OneRF Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for treating pain, or for lesioning nerve tissue for functional neurosurgical procedures. “This clearance leverages the company’s proprietary OneRF Ablation System RF generator platform
Devices
A 3/14-4/1 FDA inspection at Les Encres LLC in Lenoir City, TN, found multiple violations in the firm’s work as a specification developer of Les Encres absorbable polydioxanone surgical suture devices. A just-released 7/30 Warning Letter says Quality System regulation violations were: * failure to
Devices
Tandem Diabetes Care has recalled (Class 1 device correction) for certain t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. “The error, which appears as a Malfunction 16 alarm to the user, will stop insulin
Devices
FDA has issued an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notification to users that the devices’ software should be corrected before continued use. The issue is related to software anomalies that may result in a blank
Devices
FDA has issued an alert after becoming aware that Medtronic recently sent a letter to customers recommending that certain DLP Left Heart Vent Catheters be removed from where they are used or sold. Reports have been received about affected products resisting shape retention when being bent, according to the alert,
Devices
Thoratec has recalled (Class 1) its HeartMate Mobile Power Unit AC power cords due to unintended power disruptions. According to a just-posted recall notice, a misaligned V-Lock feature on the cords may cause an unintended disconnect. Customer advisory letters were recently sent stating that affected cords will be
Devices
FDA has granted de novo authorization for the ArteraAI Prostate test, the only artificial intelligence (AI)-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. A company statement says the authorization establishes a new product code category for future AI-powered digital pathology risk-
Devices
DeepSight Technology says it has received 510(k) clearance for its NeedleVue LC1 Ultrasound System, a device designed to deliver high-precision imaging for image-guided medical procedures. The device works by “leveraging” the company’s proprietary NeedleVue and OnPoint Imaging technologies to provide “real-time, highly accurate, ultrasound-based
Devices
A 9/10-9/13/2024 FDA inspection at the Spectra Therapy facility in Port Huron, MI, found multiple types of violations in the firm’s manufacturing of the LASERwrap system of therapeutic heating infrared lamps. A 7/22 Warning Letter says Quality System Regulation violations were: * failure to establish
Devices
Draeger is recalling (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide (CO₂) readings. The filters are used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination. A recall notice says that misleading carbon dioxide readings could result in healthcare
FDA Policy/General
Infactory CEO Brooke Hartley Moy says she was not surprised when FDA’s internal artificial intelligence tool Elsa started producing fake research data. Interviewed for an online Cybernews report, Moy says AI models are still far from perfect and are known to hallucinate facts, oversimplify nuance, and generate confident nonsense.
Devices
Medical device manufacturers should be using FDA Warning Letters as a source of strategic intelligence that highlights recurring patterns, systemic gaps, and evolving priorities that can be used to strengthen compliance and drive operational excellence. That’s the view of “independent expert” Marcelo Trevino, writing in a MedDevice Online column.
Devices
FDA has approved Nyxoah’s Genio system, a hypoglossal nerve stimulation (HGNS) therapy for certain patients with moderate to severe obstructive sleep apnea. The device is intended for adults with an Apnea-Hypopnea Index (AHI) between 15 and 65 events per hour. The company says Genio offers HGNS treatment by