The FDA today issued a field safety notice deeming a recall of Abiomed Impella 5.5 heart pumps as Class I, the most serious kind. Abiomed — bought by Johnson & Johnson for $16.6 billion last year — recalled 466 affected devices. It distributed these Impella 5.5 with SmartAssist devices between Sept. 28, 2021, and March […]
FDA
FDA approves Zoll therapy for sleep apnea with MRI
Zoll Medical announced that it received FDA approval for its Remedē system for conditional use with magnetic resonance imaging (MRI). Chelmsford, Massachusetts-based Zoll designed its Remedē system as an implantable, transvenous phrenic nerve stimulation therapy. It treats adults with moderate to severe central sleep apnea (CSA). Full-body MRI approval applies to all models of the […]
ICU Medical recalls certain infusion pump replacement batteries
The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind. ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems. The infusion systems […]
FDA clears automated insulin pump from Beta Bionics for type 1 diabetes
The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software. FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas. Using an […]
Virtual Incision submits surgical robot for FDA de novo review
Virtual Incision announced that it submitted its MIRA surgical robot to the FDA for de novo review. Lincoln, Nebraska-based Virtual Incision seeks authorization to market MIRA for use in bowel resection procedures. The submission follows a completed FDA investigational device exemption (IDE) study. FDA approved the IDE supplement for MIRA in April 2022. MIRA could […]
Paradromics raises $33M, wins FDA breakthrough nod for brain-computer interface tech
Paradromics announced today that it raised $33 million in a Series A funding round and garnered an FDA breakthrough device designation. Austin, Texas-based Paradromics develops a high data-rate brain-computer interface (BCI). The company sees its latest financial and regulatory progress as a positive step into the competitive BCI market. Paradromics plans to use the funding […]
FDA clears insertable cardiac monitor from Abbott
Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM). The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio of connected health devices for managing and treating patients remotely. The device could potentially rival the Medtronic Linq system. […]
FDA clears AI software for MRSA diagnostics from BD
BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its new Kiestra imaging application that uses AI. The Kiestra methicillin-resistant staphylococcus aureus (MRSA) imaging application uses AI to interpret bacterial growth and release negative specimens with minimal human interaction. Franklin Lakes, New Jersey-based BD designed the Kiestra MRSA application to utilize AI to […]
FDA approves expanded label for Abbott Eterna spinal cord stimulation tech
Abbott (NYSE:ABT) announced today that the FDA approved expanded MRI labeling for its Eterna spinal cord stimulation (SCS) system. The expanded labeling includes new leads that are MR (magnetic resonance) conditional. It means people with chronic pain can undergo MRI scans within approved, outlined conditions with a wider selection of lead options for full-body scans. […]
Cue Health submits RSV molecular test to FDA for de novo clearance
Cue Health (Nasdaq:HLTH) announced today that it made a de novo submission to the FDA for clearance of its RSV molecular test. The submission aims to garner full clearance of the test for at-home and point-of-care use. According to Cue Health, no respiratory syncytial virus (RSV) tests exist on the market for home use. Pending […]
FDA approves ophthalmic spray from Eyenovia
Eyenovia (Nasdaq:EYEN) announced today that the FDA approved its Mydcombi treatment for use with the Optejet delivery device. New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. It marks the first approved fixed-dose combination of tropicamide and […]