Devices
FDA has granted 510(k) clearance to the Orthofix Forza titanium TLIF spacer system. The company says the Forza spacer with nanovate technology is a titanium 3D-printed interbody featuring an optimized design, porosity, and surface that allows bone to grow into and through the spacer. “Interbody implants are spacers
Devices
FDA has approved Medtronic’s Pipeline Flex embolization device with Shield Technology. The company says it developed Shield Technology, a proprietary breakthrough in biomaterial science, to advance flow diversion therapy by introducing the first surface-modified implant device that demonstrates a reduction in material thrombogenicity. The Pipeline device has been
Devices
FDA has cleared a LivaNova 510(k) for B-Capta, an in-line, blood-gas monitoring system integrated into its S5 heart-lung machine. The device is designed to monitor arterial and venous blood gas parameters during long and complex pediatric and adult cardiopulmonary bypass procedures, the company says. B-
Devices
FDA has cleared a Johnson & Johnson Vision 510(k) for its next generation Veritas Vision System, a phacoemulsification (cataract surgery) device that allows surgeons to guide through any lens density with less surge and more stability, according to the company. The new system also is intended to improve ergonomics
Devices
FDA says a Medtronic 3/3 recall of 93 units of its Bio-Console 560 extracorporeal blood pumping console due to possible electrical failure causing the pump to stop is a Class 1 recall. An agency notice says the units were distributed between 4/1/09 and 2/12. The
Devices
FDA has cleared a Zimmer Biomet 510(k) for the Rosa Partial Knee System for robotically-assisted partial knee replacement surgeries. The device features proprietary 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on soft-tissue and bone anatomy to improve bone cut accuracy and
Devices
AdvaMed says an FDA action plan on artificial intelligence/machine learning-based software as a medical device (SaMD) should clarify which aspects of the plan also apply to software in a medical device (SiMD). “We generally believe FDA should apply the same policies to SiMD as it does for SaMD
Devices
At the second MDUFA 5 reauthorization meeting between FDA and industry, held on 3/17, seven items were discussed. A meeting summary lists the items as: * Stakeholder feedback on MDUFA reauthorization from a 10/27/20 public meeting; * FDA perspective on MDUFA 4 performance, noting that the agency disagrees with
Devices
CDRH director Jeffrey Shuren says FDA has issued an amendment for many molecular diagnostic Covid-19 tests that had received an emergency use authorization. Under the amendment, if a test developer has self-certified it has validated its test for pooling, FDA will add that test to a list of
Drugs
The DC Circuit Court of Appeals has affirmed in a 4/16 decision a district court decision that FDA is not afforded discretion when a combination product meets the definition of both a device and a drug. At issue in Genus Medical Technologies v. FDA was that having a product
Devices
Tenacore is recalling Alaris Pumps it serviced because the bezel repair posts may crack or separate leading to inaccurate delivery of fluids to patients. The separation of one or more bezel repair posts may result in free flow of fluids to patients, fluid over delivery or under delivery, fluid interruption
Devices
FDA has sent Block Scientific a Warning Letter after reviewing the firm’s Web site (www.blockscientificstore.com) and determining it is marketing Covid-19 test kits without agency approval, clearance, or authorization. FDA also said the products are misbranded because Block failed to notify the agency of its intent
Devices
Becton Dickinson has recalled (Class 1) its CareFusion 303 Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry. The issue could lead to keys that become unresponsive or stuck, and this may lead to an infusion delay or interruption, a recall notice says.
Devices
FDA has granted Perimeter Medical Imaging AI a breakthrough device designation for its Optical Coherence Tomography Imaging System coupled with ImgAssist AI. The device is designed to offer advantages over existing alternatives for intra-operative evaluation of margins during breast cancer lumpectomy, according to the company. Perimeter says it is
Devices
CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say the Covid-19 pandemic has caused “unprecedented workload demands” on Center staff and resulted in delays in the Center’s “conventional” workload, including some tasks covered by MDUFA time commitments. Writing in an online post,
Devices
FDA has selected Intertek as an accredited testing laboratory under the agency’s Accreditation Scheme for Conformity Assessment Pilot Program. With the selection, 12 affiliates within Intertek’s global lab network are authorized to help manufacturers around the world with medical device premarket testing to access the U.S market,
Devices
FDA has lifted a partial clinical hold against a Panbela Therapeutics Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treating patients with metastatic pancreatic ductal adenocarcinoma. Panbela says that due to recently observed serious visual adverse
Devices
FDA has granted Qorvo an emergency use authorization for the Qorvo Omnia SARS-CoV-2 Antigen Test. The test is authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of Covid-19. The diagnostic uses high-frequency
Devices
CDRH has posted new modules on its multi-media Web page CDRH Learn. The Center says learning modules describe many aspects of medical device and radiation emitting product regulations, covering both premarket and postmarket topics. The tool is intended to provide industry with information that is comprehensive, interactive, and easily
Devices
FDA has cleared an expanded indication for the use of the Avitus Bone Harvester technology to debride and capture infected, necrotic, or diseased cancellous bone, such as in the removal of osteomyelitis and cancellous bone tumors. Avitus Orthopaedics says the device is a suction-powered surgical instrument that enables surgeons
Devices
FDA has classified as Class 1 a Medtronic recall of all unused Valiant Navion thoracic stent grafts due to stent fractures and endoleak concerns. “Following device implantation, patients may experience stent ring enlargement beyond design specification, stent fractures, holes in the graft fabric (Type III endoleaks), life-threatening bleeding, aortic
Devices
Smisson-Cartledge Biomedical has recalled (Class 1) its ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a cassette that warms fluids directly with an aluminum plate may leak aluminum into the fluids and expose patients to high levels of the metal. The recall is specific to the disposable cassette