Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing. Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing […]
FDA
Neurolief wins FDA breakthrough nod for wearable neuromod for depression
Neurolief announced today that it received FDA breakthrough device designation for its Relivion DP system for treating major depression. Relivion is a wearable, non-invasive, multi-channel brain neuromodulation device designed as an adjunctive treatment to pharmaceutical management of major depressive disorder (MDD) in adults who haven’t experienced satisfactory improvement from antidepressant medications, according to a news […]
Report: Will Dr. Hahn crack under political pressure?
Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration, according to a New York Times report. Hahn […]
FDA issues EUA for Helix COVID-19 NGS test
Helix announced today that it received FDA emergency use authorization (EUA) for its Helix COVID-19 next-generation sequencing (NGS) test. San Mateo, Calif.-based Helix’s NGS test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 (the virus causing coronavirus) in upper respiratory specimens from individuals suspected of having COVID-19 by their healthcare provider, according […]
FDA revokes Autobio antibody test EUA
The FDA issued a letter announcing that it revoked the emergency use authorization (EUA) for a COVID-19 test from Autobio Diagnostics. Autobio’s SARS-CoV-2 rapid antibody test received EUA on April 24 for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood or serum. Authorization for the […]
FDA clears LifeSpine anterior lumbar spacer system
Spinal disorder treatment developer Life Spine announced that it received FDA clearance for its Plateau-A Ti anterior lumbar spacer system. Huntley, Ill.-based Life Spine’s Plateau-A Ti system can be used for anterior fusion procedures, offering multiple footprint sizes in various heights to accommodate individual anatomies and pathologies, according to a news release. The system also […]
Siemens Healthineers wins FDA clearance for in-bed CT head scans
Siemens Healthineers (ETR:SHL) announced today that the FDA cleared its Somatom On.site mobile head computed tomography (CT) scanner. Malvern, Pa.-based Siemens Healthineers’ Somatom On.site scanner enables critically ill patients to receive CT head imaging in the intensive care unit (ICU) while remaining in bed, eliminating costly transports to the radiology department, according to a news […]
FDA issues EUA for Abiomed Impella heart pumps for COVID-19 therapy
Abiomed (NSDQ:ABMD) announced today that the FDA issued emergency use authorization (EUA) for its Impella heart pumps in COVID-19 therapy. The EUA covers the left-sided Impella pumps in providing left ventricular unloading, supporting COVID-19 patients who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and develop pulmonary edema or myocarditis, according to a news release. Impella, the […]
FDA approves new Medtronic neurostim leads
Medtronic (NYSE:MDT) announced today that it received FDA approval for its InterStim Micro neurostimulator and SureScan MRI leads. Fridley, Minn.-based Medtronic’s InterStim Micro device for delivering sacral neuromodulation (SNM) therapy is used in treating overactive bladder, fecal incontinence and non-obstructive urinary retention. According to a news release, it is the smallest rechargeable device of its kind. […]
J&J’s Ethicon wins FDA breakthrough nod for microwave ablation tech
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon announced that it received FDA breakthrough device designation for its microwave ablation technology. The transbronchial microwave ablation technology, which is currently under development, utilizes robotic-assisted bronchoscopy. Johnson & Johnson’s acquisitions of NeuWave Medical and Auris Health allowed the company to bring the robotic surgical and microwave ablation technology together to […]
New Quest lab method gains FDA nod
Quest Diagnostics (NYSE:DGX) announced that it received FDA emergency use authorization (EUA) for a new laboratory technique for extracting viral RNA. Secaucus, N.J.-based Quest Diagnostics’ new technique is designed to speed up the process of extracting viral RNA from specimens in an effort to expand daily capacity of COVID-19 molecular diagnostic tests in the U.S., according […]