Intuitive (Nasdaq:ISRG) announced that the FDA cleared an integration of imaging technology with the Ion robot-assisted bronchoscopy system. The integration covers a mobile cone-beam CT (CBCT) imaging technology, developed by Siemens Healthineers, called Cios Spin. Cios Spin offers integrated functionality with Ion to provide 2D and 3D imaging during procedures to help physicians gain confidence […]
Food & Drug Administration (FDA)
GE Healthcare’s Carescape ventilator battery recall is Class I
The FDA issued a notice today labeling the recall of GE Healthcare’s (NYSE:GE) Carescape R860 ventilator as Class I, the most serious kind. GE Healthcare recalled the Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so. If the ventilator is running on […]
‘Multiple disruptions’ slow timeline for Titan Medical’s Enos robotic surgery platform
Titan Medical (Nasdaq:TMDI) announced today that it updated the FDA submission timeline for its Enos robotic surgery platform. “Multiple disruptions” have resulted in an updated FDA investigational device exemption (IDE) submission timeline for the Enos robotic single access surgery system, with the Toronto-based company now expecting the IDE submission to come in mid-2023, rather than […]
Philips updates on testing results for recalled ventilators
Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after […]
Varian wins FDA IDE for Flash radiation therapy
Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical research program. Flash therapy, an experimental treatment modality, was designed to deliver radiation therapy at ultra-high dose rates in typically less than one second. The Siemens Healthineers company will conduct the feasibility study of Flash therapy for the treatment […]
Virpax to pursue over-the-counter pathway for topical spray treatment for osteoarthritis pain
Virpax Pharmaceuticals (Nasdaq:VRPX) announced today that it will pursue a direct to over-the-counter (OTC) regular pathway for Epoladerm. Berwyn, Pennsylvania–based Virpax designed the Epoladerm investigational pre-filled topical spray analgesic product for the non-addictive management of chronic pain associated with osteoarthritis (OA) of the knee. Get the full story at our sister site, Drug Delivery Business News.
FDA clears Acutus’ AcQCross system for use with Boston Scientific’s Watchman
Acutus Medical (Nasdaq:AFIB) announced today that it launched an expanded suite of left-heart access products. Following expanded FDA clearance, Acutus launched the suite to now include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Boston Scientific Watchman left atrial appendage closure device. Carlsbad, California-based Acutus designed the AcQCross […]
Baxter’s Volara lung therapy system recall is Class I
The FDA issued a notice today labeling the recall of the Baxter (NYSE:BAX) Volara lung therapy system as Class I, the most serious kind. Earlier this month, Baxter announced that it issued an urgent medical device correction for its Volara system for oscillation and lung expansion (OLE) therapy. To date, there has been one complaint […]
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff […]
3Spine wins FDA IDE for spine implant
3Spine announced today that it received FDA investigational device exemption (IDE) for its Motus spinal implant device. Chattanooga, Tennessee-based 3Spine designed the Motus device for use in the BalancedBack total joint replacement procedure. 3Spine’s BalancedBack procedure is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level […]
FDA grants breakthrough nod for Carthera’s SonoCloud-9
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound […]
