Devices
Ambu is recalling (Class 1) its SPUR II resuscitators due to the manometer port being blocked, which causes the manometer to become non-functional. “This defect can lead to an increased risk of harm caused by pressure changes (barotrauma) and delayed ventilation, since the ventilation pressure applied with Ambu SPUR
Devices
Hamilton Medical is recalling (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage of production that may lead to a crack in the inner blue limb of the circuit. “The inner blue limb delivers fresh gas to
Devices
Integra LifeSciences is recalling (Class 1) its Extended Tip Applicators because the products may have high levels of harmful substances and may not have gone through a fully documented sterilization process. “Use of the affected product may cause serious adverse health consequences, including inflammation, infection, and death,” a recall notice
Devices
FDA has issued an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella controllers be removed from where they are used or sold. The company stated that affected devices have a pump driver circuit assembly that does not meet current specifications. “These pump
Devices
A 1/27-1/30 FDA inspection at the Uscom Kft facility in Budapest, Hungary, determined that the company is illegally manufacturing and marketing several spirometers for which it does not have an approved PMA or IDE in effect. A just-released 7/30 Warning Letter also lists these Quality
Devices
A 3/4-4/16 FDA inspection at the LeMaitre Vascular facility in North Brunswick, NJ, found Quality System Regulation violations in the firm’s manufacturing of Artegraft Collagen Vascular Grafts. An 8/11 Warning Letter says the specific Quality System violations were: * failure to establish and maintain procedures to
Devices
A 3/31-4/23 FDA inspection at the Miach Orthopaedics facility in Westborough, MA, identified 11 Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of the Bridge-Enhanced ACL Restoration implant intended to treat anterior cruciate ligament injuries. An 8/19 Warning Letter says
Devices
FDA has granted Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, treatment-resistant systemic lupus erythematosus. This is the second time the device has earned the designation, following earlier recognition for treating sepsis. NucleoCapture is described as an extracorporeal apheresis column designed to
Devices
FDA has granted Quest Diagnostics a breakthrough device designation for its Haystack MRD test, a liquid biopsy designed to detect minimal residual disease (MRD) in patients with Stage II colorectal cancer after curative surgery. Quest says it introduced a laboratory-developed version of Haystack MRD in late 2024 and has
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