CeloNova Biosciences said today that the FDA approved an expansion of the on-going clinical trial for its Cobra PzF nano-coated coronary stent with 14-day dual antiplatelet therapy in complex patients, like people who are at a high risk of bleeding. The company touted its Cobra Reduce trial as the first randomized control trial to study 14-day […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Iradimed wins FDA nod for MR-compatible patient monitoring system
iRadimed (NSDQ:IRMD) said today that it won 510(k) clearance from the FDA for its 3880 MR-compatible patient monitoring system. The 3880 device is designed to allow patients to be transported from critical care units for magnetic resonance imaging scans without interruption to vital signs monitoring. Winter Springs, Fla.-based Iradimed claims it as the smallest and most-portable […]
FDA warns UVLrx Therapeutics over clinical trial missteps
The FDA this week released a warning letter it sent to UVLrx Therapeutics over issues with an unapproved study of an intravascular catheter, citing failures to obtain approval for the trial alongside a number of other violations. The federal watchdog said that concerns were raised after an inspection performed between March 27 and April 4 […]
FDA expands indication for Attune Medical’s Enso esophageal temperature management device
Attune Medical said today that it won an expanded indication from the FDA for its Enso esophageal temperature management device. Formerly known as Advanced Cooling Therapy, Chicago-based Attune said the new indication covers extended duration of use for up to 72 hours. The triple lumen system is designed to be inserted into the esophagus, with two lumens […]
FDA approves pivotal trial for Insightec’s Exablate Neuro in Parkinson’s
Insightec said today that it won FDA approval for a pivotal trial of its Exablate Neuro device in treating refractory Parkinson’s disease. Haifa, Israel-based Insightec said the the study will evaluate using Exablate Neuro’s MR-guided focused ultrasound to ablate portions of the globus pallidus in the brain, which helps regulate voluntary movement. The trial, led by […]
FDA head Gottlieb touts release of 1st medical device development tool
The FDA today announced its 1st qualified medical device development tool as part of the agency’s Medical Innovation Access Plan announced by Commissioner Scott Gottlieb earlier this year. The tool is a 23-item questionnaire designed to measure health information which is reported directly by patients with heart failure. The questionnaire is intended to be used […]
FDA clears Acutus Medical’s AcQMap cardiac mapping tech
Acutus Medical said today that it won 510(k) clearance from the FDA for its AcQMap high-resolution imaging & mapping system and the 3D mapping catheter that goes by the same name. Carlsbad, Calif.-based Acutus said it plans to have the system on the U.S. market early next year. It’s designed to detect and display standard voltage-based […]
Medineering touts EU approval of its robotic positioning arm
Medineering, the German maker of surgical robotics, disclosed that its positioning arm won CE Mark approval from the European Commission. Approval means the company’s positioning arm is now OK’d for holding and positioning passive adapters and robots in otolaryngology (ear, nose & throat), neurosurgery and spinal surgery. The positioning arm “is the base of a […]
Renishaw wins FDA approval for neurosurgery planning software
Renishaw, a British engineering company, received approval by federal officials to sell the latest version of its neurosurgery planning software in the U.S. The FDA granted 510(k) clearance for Renishaw’s neuroinspire software that blends MRI and CT datasets into a 3D volume, enabling neurosurgeons to identify and outline regions of interest. The approach is designed to minimize […]
FDA warns Magellan Diagnostics on lead tests
The FDA today warned Meridian Bioscience (NSDQ:VIVO) subsidiary Magellan Diagnostics based on the Class I recall of its lead poisoning tests, accusing the company of failing to protect patients after it learned of problems with the tests. The May recall, which was expanded in July, involves Magellan’s LeadCare, LeadCare II, Ultra and Plus products. The tests may underestimate blood lead levels […]
OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years
Just last week, OptiScan Biomedical announced that its OptiScanner 5000 glucose monitoring system won 510(k) clearance for use in surgical intensive care units. The regulatory win was supported by eight rigorous clinical trials, CEO Peter Rule told Drug Delivery Business News, and represents a victory for a technology that the company hopes to expand into a platform system. Get the […]