CVRx (Nasdaq:CVRX) announced today that the FDA approved magnetic resonance (MR) conditional labeling for its Barostim system. The Barostim neuromodulation system for treating the symptoms of heart failure now includes instructions to allow for safe MRI scans of the head and lower extremities, offering heart failure patients implanted with Barostim more diagnostic options. Minneapolis-based CVRx […]
FDA
FDA clears Philips’ MR 7700 imaging system
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its new MR 7700 3.0T MR imaging system. Amsterdam-based Philips said it designed the MR 7700 system to provide high accuracy to support clinical diagnostics through high-quality diffusion imaging and advanced neuroscience. The company said in a news release that MR 7700 expands scanning […]
FDA clears Abbott’s test for simultaneously detecting four sexually transmitted infections
Abbott (NYSE:ABT) announced today that it received FDA clearance for its Alinity m STI (sexually transmitted infection) assay. The Abbott Park, Illinois–based company designed its test to simultaneously detect and differentiate four common STIs: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG). According to a news release, the first-of-its-kind multiplex […]
Orthofix wins FDA PMA for bone growth stimulation device
Orthofix (Nasdaq:OFIX) announced today that it received FDA premarket approval (PMA) for its AccelStim bone healing therapy device. Lewisville, Texas-based Orthofix designed the AccelStim device to provide a safe and effective nonsurgical treatment for indicated fresh fractures and for fractures that have not healed (nonunions). According to a news release, the device generates a low-intensity […]
FDA may order Philips to resolve respiratory devices recall
The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices. FDA’s proposal regards the June 2021 recall of millions of certain Philips ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement […]
FDA signals careful approach in authorizing COVID-19 vaccines in young children
FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months […]
FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes
The FDA is evaluating the risk of Medtronic (NYSE:MDT) silicone-based electromyogram (EMG) endotracheal tubes following reports of deaths and serious adverse events. The FDA issued the warning last week in a letter to healthcare providers concerning the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes. They are the only silicone-based EMG […]
Medtronic investigates HVAD pump welds after patient deaths
Medtronic (NYSE:MDT) is investigating a new problem with its HeartWare Ventricular Assist Device (HVAD) nearly one year after halting sales and new implantations of the device. Fridley, Minnesota-based Medtronic said it received three complaints of suspected pump thrombosis in patients. Two of the patients died after their heart pumps were exchanged. Medtronic found a malfunction when inspecting […]
Ear-puffing device for migraine treatment wins FDA breakthrough designation
A handheld device that treats migraine attacks with puffs of air in a patient’s ears has been designated a breakthrough device by the FDA. Tempe, Arizona-based Nocira said it is the first company to announce breakthrough device designation for treating migraine attacks in both chronic and non-chronic migraine patients ages 18 and up. The device […]
FDA clears Onera Health’s at-home sleep diagnostic
Onera Health announced today that it received FDA 510(k) clearance for its Onera STS system for polysomnography (PSG) studies. Eindhoven, The Netherlands–based Onera’s patch-based technology aims to transform the outdated, cumbersome and expensive process of traditional sleep testing. Onera said in a news release that its clinical-grade technology can offer an upgrade on the traditional […]
FDA approves Transmedics OCS Heart organ transplant system
TransMedics (Nasdaq:TMDX) announced today that it received FDA premarket approval (PMA) for its OCS Heart system. FDA PMA allows Andover, Massachusetts-based TransMedics to expand the pool of eligible heart donors in the U.S. to organs from donors after circulatory death (DCD). The company had previously received PMA for the OCS Heart system for use with […]