Inari Medical has updated its instructions for using some ClotTriever XL catheters in a Class I recall due to injury and death reports. The company recalled and updated use instructions after discovering serious adverse events caused by the device entering or blocking the lung arteries. The use of affected products could continue to cause serious […]
Food & Drug Administration (FDA)
Clearmind Biomedical wins FDA clearance for Neuroblade minimally invasive neuroendoscopy tech
Clearmind Biomedical announced today that it received FDA 510(k) clearance for its Neuroblade neuroendoscopy system. The novel system enables minimally invasive procedures with integrated features such as visualization, illumination, irrigation, suction, coagulation, and powered debridement. San Jose, California-based Clearmind also announced the first completed U.S. surgery using Neuroblade. Dr. Christopher Kellner performed the procedure at […]
SurGenTec wins FDA nod for bone marrow aspirate kit
SurGenTec announced today that it received FDA 510(k) clearance for its proprietary B-MAN bone marrow aspirate kit. Boca Raton, Florida-based SurGenTec says its B-MAN kit offers a cutting-edge approach to bone marrow aspiration. It utilizes a centrifuge-free method to collect high-quality aspirate with minimal contaminants. The kit’s integrated, diamond-tip trocar works simultaneously with CELLect filtration […]
Medtronic earns expanded MRI labeling for DBS systems
Medtronic announced today that the FDA approved expanded MRI labeling for its deep brain stimulation (DBS) systems. The FDA approved expanded labeling for the Medtronic Percept PC and RC, as well as the Activa PC, RC and SC systems. This labeling approval, exclusive to Medtronic DBS systems, allows for additional active scan time for scans […]
Si-Bone wins FDA clearance, breakthrough nod for pelvic fixation implant
Si-Bone this week announced it received FDA 510(k) clearance and FDA breakthrough device designation for its iFuse Torq TNT Implant System. The Santa Clara, California-based orthopedic company designed the TNT implant for pelvic fragility fracture fixation and sacroilliac joint fusion. TNT (through and through) is designed to meet the specific anatomical and bone mineral density […]
FDA approves label expansion for Abbott HeartMate 3 LVAD to remove aspirin from treatment regimen
Abbott announced today that the FDA approved a label change for its HeartMate 3 left ventricular assist device (LVAD). The label expansion eliminates aspirin as part of routine patient management. This update exclusively applies to patients with a HeartMate 3 pump and also has Canadian and European approval. HeartMate 3 helps the heart pump blood […]
FDA clears next-gen surgical robot from Procept Biorobotics
Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA 510(k) clearance for its next-generation Hydros robotic surgery system. Hydros delivers the San Jose, California-based company’s Aquablation therapy. The company received FDA investigational device exemption (IDE) for its Aquablation procedure in September 2023. Aquablation uses waterjet resection to precisely eradicate prostate tissue. It provides the potential […]
Stereotaxis wins CE mark for next-gen surgical robot, submits to FDA
Stereotaxis (NYSE:STXS) announced that it obtained CE mark in Europe and submitted an FDA 510(k) application for its next-generation surgical robot. The GenesisX system is the latest iteration of Stereotaxis’ Genesis robotic magnetic navigation (RMN) system. It builds upon the company’s technology while reducing the complexities and barriers to hospital adoption. Stereotaxis said in a news […]
FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Siemens Healthineers announced today that it received FDA clearance for its Acuson Origin ultrasound system and AcuNav Lumos 4D ICE catheter. Acuson Origin, a new, dedicated cardiovascular ultrasound includes AI-powered features. It can help physicians perform cardiac procedures more efficiently in the areas of diagnostics, structural heart disease and electrophysiology. The AcuNav Lumos 4D ICE […]
Globus Medical stock slides in response to FDA warning letter centered around surgical robot tech
The FDA today published a warning letter issued to Globus Medical alleging violations at a Pennsylvania facility. Shares of Globus Medical — one of the largest orthopedic device companies in the world — fell more than 8% to $66.83 apiece in midday trading today. (MassDevice‘s MedTech 100 Index was up slightly.) The warning letter, dated […]
Surgical Planning Associates wins FDA nod for mixed-reality hip arthroplasty system
Surgical Planning Associates announced today that it received FDA 510(k) clearance for its HipInsight 2.0 mixed-reality guidance system. Boston-based Surgical Planning Associates developed the system for hip arthroplasty in collaboration with orthopedic giant Zimmer Biomet. It provides support for the essential steps of both primary and complex revision arthroplasty. HipInsight effectively gives surgeons “X-ray vision” […]
