Devices
FDA has cleared a Johnson & Johnson MedTech 510(k) for its Monarch Quest, which the company describes as its latest advancement in navigation technology for robotically assisted bronchoscopy. The company notes that almost half of early-stage cancer lesions are located in the periphery of the lung, which it
Devices
FDA has cleared a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer. The integrated clinical chemistry and immunoassay analyzer is designed to enhance laboratory efficiency by offering high throughput and processing up to 800 clinical chemistry tests and 100 immunoassay tests per hour, according to the company.
Devices
Dexcom says it was issued on 3/4 an FDA Warning Letter following inspections at the company’s facilities in San Diego, CA and Mesa, AZ. The letter cited deficiencies contained in response letters sent by Dexcom after receiving Form FDA-483 from the inspections. “The Warning Letter describes observed
Devices
FDA has cleared a Zimmer Biomet 510(k) for its Persona Revision SoluTion Femur, a revision knee implant as an alternative for patients with sensitivities to certain metals (nickel, cobalt, and chromium). The device “leverages a proprietary surface-hardening treatment designed to enhance wear performance, which offers surgeons an array
Devices
FDA says the Nuwellis 12/11/2024 recall of certain lots of its AquaFlexFlow UF 500 Plus extracorporeal blood circuits is Class 1. The company said the affected units may indicate “ultrafiltrate weight mismatch” or “excessive weight mismatch” alarms while in use. “If too many weight mismatch alarms occur,” the
Devices
Medtronic’s Micro Therapeutics unit has recalled (Class 1) its Pipeline Vantage Embolization Device with Shield Technology after it determined that the use of the embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and braid deformation. A recall notice says that these
Devices
FDA has granted both Breakthrough Device and Targeted Acceleration Pathway designations to Phantom Neuro’s Phantom X platform. The company describes the platform as a “minimally invasive neural interface providing intuitive control of prosthetics and robotic devices.” It says Phantom X uses sophisticated algorithms to decode natural human movement, providing
Devices
FDA has published a medical device early alert about an issue with the Baxter Sigma Spectrum Infusion System and Spectrum IQ Infusion System. The alert says Baxter has contacted affected customers recommending that certain Spectrum infusion pumps be removed from where they are used or sold. The notice says Baxter
Devices
AdvaMed says FDA should clarify in its draft guidance on protocol deviations for clinical investigations of drugs, biological products, and medical devices that derived deviations may be used in FDA reporting of protocol deviations. In a comment letter, the trade group also suggests defining key terms at the beginning of
Devices
FDA has cleared a Damae Medical 510(k) for its deepLive, described by the company as an artificial intelligence-based imaging tool that provides real-time, three-dimensional visualization of the skin. The clearance is based on data from three years of clinical experience with the device and its intuitive
Devices
Boston Scientific is recalling (Class 1) its Accolade pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers because of the possibility for them to enter “Safety Mode” during remote data collection (telemetry). “If the device enters Safety Mode, early device replacement is needed,” a recall notice says. “Once a device
Devices
Philips is recalling (Class 1) its Tack Endovascular Systems due to customer complaints, including events where additional interventions were required to retrieve or remove the implant. A recall notice recommends that customers should stop using the device immediately. Philips says it will no longer distribute the system for use. “The
Devices
Olympus is recalling certain models of its endoscope single use guide sheath kits after receiving complaints about the radiopaque tip falling off into patients. “Olympus’s preliminary findings show that the tip detaches from the guide sheath when excessive force is applied as instruments are inserted into the guide sheath,
Devices
ROi CPS is recalling (Class 1) its newborn kits after receiving an Urgent Field Safety Notice for a kit component from supplier Mercury Medical. The component is Mercury’s Neo-Tee T-Piece resuscitator, which is being removed due to an undersized spring in the controller that may prevent the
Devices
Reps. Brad Finstad (R-MN) and Dan Crenshaw (R-TX) have introduced the Freedom for Laboratory Innovation and Testing Act to block FDA from regulating laboratory-developed tests (LDTs). The representatives also wrote to HHS secretary Robert Kennedy asking that he revoke the FDA rule that was adopted during the
Devices
Ventec Life Systems has recalled (Class 1) its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which have the potential to cause unexpected shutdown. A recall notice says that using an active circuit with the device could result in inaccurate tidal volume monitor, less inspiratory volume,
Devices
FDA has cleared an Abanza 510(k) for its WasherCap Mini fixation system for soft tissue repair, including meniscal root repair and anterior cruciate ligament reconstruction. “The WasherCap Mini is the first suture and tape fixation device that offers surgeons a knotless, bidirectionally tension-adjustable solution — regardless of bone quality,
Biologics
Two stakeholders have submitted specific, line-by-line, technical comments on an FDA draft guidance on protocol deviations for clinical investigations of drugs, biological products, and devices. The comments were submitted by Labcorp and AstraZeneca.
Devices
FDA has cleared Tandem Diabetes Care’s next-generation automated insulin delivery algorithm, Control-IQ+ technology (Control-IQ+), for use in people with Type 2 diabetes ages 18 and older. The technology was previously 510(k) cleared for use in Type 1 diabetes. The Type 2 version includes enhancements to
Devices
Texas federal court judge Sean Jordan says a ruling will be issued in the consolidated suits against FDA over its final rule regulating laboratory-developed tests (LDTs) “as soon as the court can.” In a LinkedIn post, regulatory attorney Christine Bump, who attended the three-hour hearing on the suits,
Devices
FDA has cleared an Ezra 510(k) for its Ezra Flash AI model for MRI imaging. The latest version of the device is intended to enhance imaging for neuro, abdomen and pelvis MRI images. It improves image quality by reducing noise within the image while maintaining diagnostic integrity, the company
Devices
FDA has granted PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers (DFU). SkinTE is a human cellular and tissue-based product derived from a patient’s own skin to regenerate full-thickness skin with all of its layers (epidermis, dermis and hypodermis) and