Devices
FDA has granted Anumana a breakthrough device designation for its ECG-AI algorithm, which is designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure. “The use of AI algorithms to identify subtle signals in [electrocardiograms] ECGs that are imperceptible to humans
Devices
FDA commissioner Robert Califf says the agency has met with officials of the leading ChatGPT companies “and they want to be regulated. But even they don’t really have good suggestions now on how to do it.” Califf commented at a recent Biotechnology Innovation Organization convention, as reported by Bloomberg
Drugs
FDA has launched a voluntary pilot program to help cut risks in using laboratory-developed tests (LDTs) to identify cancer biomarkers. An online statement says the agency has become increasingly concerned that some tests made by laboratories and not authorized by FDA may not provide accurate and reliable test results
Devices
A 1/24-1/31 FDA inspection at Vitang Technology in Tustin, CA, determined that the firm is marketing the misbranded and adulterated UniSmile Clear Aligner, a Class 2 dental aligner that was cleared under a 510(k). A 6/12 Warning Letter says the medical device is misbranded because
Devices
FDA has approved Surmodics’ SurVeil drug-coated balloon (DCB) and its use in percutaneous transluminal angioplasty. The device is intended to be used for treating de novo or restenotic lesions (less than 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7
Devices
Philips has issued an urgent field safety notice about its Azurion and Allura Xper systems installed with the FlexMove option, which could pose a risk for patients and bystanders. It says that “due to the forces applied during the movement of the C-Arc of the Azurion and Allura systems,
Devices
FDA has approved Premia Spine’s TOPS System as an alternative to spinal fusion for treating certain patients with degenerative spondylolisthesis with moderate to severe lumbar spinal stenosis. The implant is designed to attach to the spine, and unlike a spinal fusion procedure, the TOPS System allows motion in the
Devices
FDA has cleared an American Laboratory Products 510(k) for its Calprotectin Immunoturbidimetric Assay and its in vitro diagnostic use as an aid in diagnosing inflammatory bowel disease (IBD), specifically Crohn’s disease and ulcerative colitis. It also aids in the differentiation of IBD from irritable bowel syndrome when used
Devices
FDA has cleared a Surmodics 510(k) for its Pounce LP (Low Profile) Thrombectomy System. The device was originally cleared in 2021 for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter, according to the company.
Devices
NeuroOne Medical Technologies has submitted a 510(k) for its OneRF Ablation System. The device uses already-implanted stereoelectroencephalography electrodes to record brain activity and allow for ablation of nervous tissue when connected to a proprietary radio frequency generator, NeuroOne says. The device has real-time temperature monitoring capabilities, it
Devices
FDA has published a guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, to give the industry information about the documentation the agency recommends be included in premarket submissions for software devices, including standalone software applications and hardware-based devices that incorporate software. The document
Devices
An FDA update says GE HealthCare has conducted preliminary testing on its newly manufactured neonatal incubators that suggests the potential for higher levels of formaldehyde that rapidly decrease over one week. The update is part of the agency’s ongoing evaluation of published literature that found elevated levels of formaldehyde,
Devices
FDA has granted Futura Medical a de novo marketing authorization for over-the-counter MED3000, a topical gel formulation for treating erectile dysfunction (ED) . MED3000 works through a “unique evaporative mode of action,” according to the company. The non-medicated hydro-alcoholic gel's authorization is based on data
Devices
BearCare has recalled (Class 1) its rechargeable Walnut Wearable Smart Thermometer due to reports about skin burns and irritation from using the devices. “Potential overheating and leakage of corrosive chemicals from the device could cause skin irritation, burns, other serious injuries, or death,” a recall notice says. To date, the
Devices
FDA has cleared a GE HealthCare 510(k) for the Sonic DL – a deep learning-based technology designed to dramatically accelerate image acquisition in magnetic resonance imaging (MRI). “Sonic DL enables new imaging paradigms, such as high-quality cardiac MRI in a single heartbeat,” the company says. The device is
Devices
FDA is alerting health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall by Getinge/Maquet of its Quadrox oxygenators and certain Getinge/Maquet venous hardshell cardiotomy reservoirs due to potentially compromised packaging sterility that may result in the risk of infection and
Devices
FDA has cleared a SurGenTec 510(k) for its TiLink-L Sacroiliac Joint Fusion System, a device that can be implanted from a lateral or posterior/oblique approach. The company says the device’s design allows for superior compression across the joint, and it features SurGenTec’s proprietary Nanotex surface
Drugs
Novartis says a current FDA guidance on patient preference information (PPI) pertains only to medical device development. “A common guidance on PPI that applies to devices, drugs, and drug-device combinations would help medicine developers in consistently applying the same principles and methods throughout medical product development,” the company says
Devices
FDA has approved an Avita Medical PMA supplement for use of its Recell System to treat full-thickness skin defects. “The expanded indication represents a broad label of full-thickness skin defects, such as wound injuries after traumatic avulsion (e.g., degloving), surgical excision (e.g., necrotizing soft tissue infection)
Devices
FDA has cleared a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire – a bipolar temporary device designed specifically for use during transcatheter aortic valve replacement and bicuspid aortic valve procedures. It offers dual functionality, supporting both valve delivery and ventricular bipolar pacing during procedures, the company says. “From its
Devices
AdvaMed says it agrees with five questions FDA proposes adding to a proposed future revision of a guidance on voluntary submission of patient preference information (PPI) in PMAs, HDEs, and de novo requests. The association’s comment letter also recommends adding an additional question about the characteristics of the respondents
Devices
An 8/15-8/19/22 and 11/3-11/8/22 FDA inspection at Steiner Biotechnology in Henderson, NV, found multiple violations in the firm’s manufacturing and labeling of several dental bone grafting products. A just-released 5/19 Warning Letter says specific Quality System Regulation violations were: