Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication. The FDA approved Tandem’s 510(k) application for the use of Mobi in individuals two years of age and older. In an SEC filing dated April 1, the company said the decision came through on March 21. Previously, […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA clears Baxter Novum IQ large-volume infusion pump, Dose IQ safety software
Baxter (NYSE:BAX) announced today that the FDA granted 510(k) clearance for its Novum IQ large-volume infusion pump (LVP) with Dose IQ safety software. Clearance adds the LVP to the Novum IQ platform, which already includes the Baxter syringe infusion pump (SYR). It enables clinicians to utilize a single, integrated system across a variety of patient […]
FDA clears sleep monitoring software from Beacon Biosignals
Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring. SleepStageML automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings. It aids in the diagnosis and evaluation of sleep and sleep-related disorders. Boston-based Beacon Biosignals said in a news release that the software could enable […]
Neuralink may be getting some scrutiny on Capitol Hill
Reuters reports that U.S. Rep. Earl Blumenauer (D-OR) issued a letter to the FDA questioning its inspection practices related to Neuralink. The report said Blumenauer asked why the FDA decided not to investigate the Elon Musk-backed brain chip maker before allowing in-human trials. This relates to repeated questions around animal practices at the company. Reuters […]
Synaptive Medical wins FDA nod for near-infrared fluorescence in robotic exoscope
Synaptive Medical announced today that it received FDA 510(k) clearance for its near-infrared fluoresence visualization module on its robotic exoscope. The Toronto-based company can now add its Modus IR module to the existing fluorescence offering on the 4K, 3D Modus X system. Modus IR bolsters the capabilities of the exoscope across all neurosurgical procedures, as […]
SyntheticMR wins FDA clearance for 3D brain scanner
SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance. Linköping, Sweden-based SyntheticMR said in a news release that the regulatory nod “marks a significant advancement in quantitative MRI technology.” The company says its SyMRI 3D offering provides “unprecedented resolution and accuracy in brain imaging.” Approval marks the second […]
FDA wants to ban electrical stimulation devices for self-injurious, aggressive behavior
In a rare move, the FDA is taking steps to ban electrical stimulation devices (ESDs) for self-injurious or aggressive behaviors. Owen Faris, acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, announced the proposal this week, marking the second attempt by the agency to […]
FDA approves next-gen Evolut TAVR system from Medtronic
Medtronic announced today that the FDA approved its next-generation Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The FDA’s approval covers the treatment of symptomatic aortic stenosis. Medtronic says the latest version of the Evolut valve maintains the performance of the Evolut platform with a design that facilitates coronary access. Evolut FX+ TAVR offers larger […]
FDA clears redesigned kidney stone treatment tech from Calyxo
Calyxo announced today that it received FDA clearance for its new, redesigned CVAC system for minimally invasive kidney stone treatment. Pleasanton, California–based Calyxo’s CVAC system uses irrigation and aspiration to remove kidney stones. The design aims to minimize residual stone burden. CVAC’s original design, which used steerable ureteroscopic renal evacuation (SURE) already successfully treated more […]
GE HealthCare to distribute newly FDA-cleared remote patient support tech
GE HealthCare today announced it will distribute Ionic Health’s nCommand Lite, now that the tech has secured FDA 510(k) clearance. Ionic Health designed nCommand Lite to support remote patient scanning, image viewing/review and real-time guidance from remote experts during scanning procedures. It aims to address staffing shortages in radiology departments. GE Healthcare will exclusively distribute […]
FDA clears Neuronetics’ neurostim for adolescents with depression
Neuronetics (Nasdaq:STIM) announced today that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as an adjunct treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. Neuronetics said clearance makes NeuroStar the first and only transcranial magnetic stimulation (TMS) treatment cleared for […]