Aerin Medical announced today that it received FDA 510(k) clearance and launched its next-generation RhinAer stylus. Sunnyvale, California-based Aerin designed the system as a non-invasive, temperature-controlled radiofrequency technology. It treats the causes of rhinorrhea (runny nose), post-nasal drip and congestion associated with chronic rhinitis in a single session. The new RhinAer provides physicians with improved […]
FDA
FDA clears Medtronic RespArray patient monitor for procedural sedation and medical-surgical units
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its RespArray patient monitor. Fridley, Minnesota-based Medtronic designed RespArray for procedural sedation and medical-surgical units. It features Nellcor pulse oximetry and Microstream capnography. RespArray also offers electrocardiogram (ECG), non-invasive blood pressure (NiBP) and temperature monitoring. Algorithms help to detect respiratory compromise early and reduce […]
FDA approves expanded label for Boston Scientific Watchman FLX
Boston Scientific (NYSE:BSX) announced today that the FDA approved expanded labeling for its Watchman FLX LAAC device for stroke prevention. The approval includes labeling with a 45-day dual anti-platelet therapy (DAPT) option for the left atrial appendage closure device (LAAC). DAPT represents an alternative to 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of […]
FDA clears new Viz.ai algorithm for measuring ventricles in identifying pulmonary embolism
Viz.ai announced today that it received FDA 510(k) clearance for its automated RV/LV ratio algorithm as part of the Viz PE solution. San Francisco-based Viz.ai designed its algorithm to quickly and accurately measure the diameter of the ventricles of the heart. The measurements provide the ratio of the maximum right ventricle (RV) diameter versus left […]
Integra’s CereLink ICP Monitor recall is Class I
The FDA has labeled the recall of the Integra LifeSciences (Nasdaq:IART) CereLink system as Class I, the most serious kind. Integra designed its CereLink system for intracranial pressure (ICP) monitoring. Last week, the company announced an immediate, voluntary global product removal of the systems. An FDA notice classified the U.S. recall, initiated by Integra on […]
FDA clears syringe infusion pump with Dose IQ software from Baxter
Baxter (NYSE:BAX) announced today that the FDA issued 510(k) clearance to its Novum IQ infusion pump with Dose IQ safety software. Deerfield, Illinois-based Baxter designed its new Novum IQ syringe infusion pump (SYR) to deliver small amounts of fluid at low rates. It includes a technologically integrated user experience with enhanced safety features. The system offers […]
Philips Respironics has a new recall for certain ventilators
Philips (NYSE:PHG) has a new recall for its ventilators, adding to recall issues that have plagued the company for a year. The FDA issued a notice alerting patients, caregivers and providers that certain Philips Respironics bi-level positive airway pressure (BiPAP or BPAP) machines may contain a plastic contaminated with a non-compatible material. If such plastic […]
CereVasc completes first eShunt procedure in U.S.
CereVasc announced today that it completed the first procedure with its eShunt device in the U.S. as part of a pilot study. Boston-based CereVasc’s first eShunt procedure was completed as part of a U.S. pilot study of the system in normal pressure hydrocephalus (NPH) being conducted under FDA investigational device exemption (IDE). Approval for the […]
FDA clears Surgalign’s Cortera spinal fixation system
Surgalign (Nasdaq:SRGA) announced today that it received FDA 510(k) clearance for its Cortera spinal fixation system. Deerfield, Illinois-based Surgalign said in a news release that the new flagship Cortera product represents a key product portfolio piece. Surgalign officials see Cotera driving the company’s future growth. It could ensure market gains in the posterior fixation market. […]
7 brain-computer interface companies you need to know
Blackrock Neurotech, BrainGate, ClearPoint Neuro, Neuralink, Synchron and more race to bring brain-computer interface (BCI) tech to market. They’re using a multitude of methods — and developing their own systems that would allow patients to control a computer with their brain. Such technology could potentially enable countless immobile people someday to control a mouse cursor, […]
FDA approves Abbott’s next-gen spinal cord stimulation therapy
Abbott (NYSE:ABT) announced today that the FDA approved its new Proclaim Plus spinal cord stimulation (SCS) system with FlexBurst360. The FlexBurst360 therapy is the next generation of Abbott’s proprietary BurstDR stimulation. Abbott designed it to provide pain coverage across up to six areas of the trunk and/or limbs. It has programming that adjusts as a […]