The FDA today issued an alert related to a potentially high-risk device issue with certain Conavi Novasight Hybrid catheters. Its communication comes as part of its pilot to enhance the medical device recall program. The FDA said it became aware of the issue after Conavi sent a letter to affected customers recommending the removal of […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Sanoculis wins CE mark for minimally invasive glaucoma treatment device
Sanoculis announced that it received CE mark for its MINT (minimally invasive nasal trabeculostomy) product. MINT, a stent-free platform, helps treat adult patients undergoing glaucoma angle surgery. The system utilizes a unique mechanical, semi-automated trephination technology. Its cutting-edge diameter of 0.14 mm creates precise openings in the pigmented trabecular meshwork. Tel Aviv, Israel–based Sanoculis said […]
BVI Medical wins FDA nod for laser endoscopy ophthalmic system
BVI Medical announced that it received FDA 510(k) clearance for its Leos (laser endoscopy ophthalmic system) for treating glaucoma. Waltham, Massachusetts–based BVI designed Leos for a more intuitive laser endoscopic cyclophotocoagulation (ECP) procedure. It aims to integrate seamlessly into the surgical workflow while treating glaucoma. The company says Leos is the only laser system that […]
Luma Vision wins FDA clearance for cardiac visualization platform
Luma Vision recently announced that the FDA has cleared its Verafeye catheter-based cardiac imaging system. The company — based in Dublin, Ireland, and Munich, Germany — describes Verafeye as a novel catheter-based imaging system that provides real-time, two and four-dimensional, 360-degree visualization, enhancing clinician precision and confidence during complex electrophysiology and structural heart procedures. Luma […]
Solo Pace wins FDA clearance for temporary pacing during TAVR
Solo Pace announced today that it received FDA clearance for its SoloPace Control System for temporary pacing in TAVR procedures. Along with FDA clearance, the company announced the first-in-human use of the system in a transcatheter aortic valve replacement (TAVR). Designed with standardized workflows, the system improves TAVR temporary pacing efficiency and reduces patient risks. […]
Adagio Medical wins FDA breakthrough nod for cryoablation tech
Adagio Medical (Nasdaq:ADGM) announced today that it received FDA breakthrough device designation for its vCLAS cryoablation system. The Laguna Hills, California–based company based its vCLAS cryoablation catheter on its proprietary ultra-low cryoablation technology (ULCT). It aims to address the challenges of ventricular tachycardia (VT) ablations, comprising part of the Adagio VT cryoablation system. The system’s […]
Precision Neuroscience wins FDA clearance for BCI cortical interface
Precision Neuroscience announced today that it received FDA 510(k) clearance for its Layer 7 cortical interface for BCI technology. The Layer 7 thin-film brain-computer interface (BCI) features 1,024 electrodes embedded in a flexible film that conforms to the brain surface. The film comes in at one-fifth the thickness of a human hair. This device aims to help […]
DESKi wins FDA clearance for HeartFocus software
DESKi today announced FDA clearance of HeartFocus, its AI-enabled heart exam software. Bordeaux, France–based DESKi says it only takes a few hours of training for any healthcare professional, including novices, to perform clinical-quality heart scans from any compatible device using HeartFocus. The FDA also signed off on DESKi’s Predetermined Change Control Plan (PCCP) for HeartFocus’ […]
EBR wins FDA nod for leadless pacing system
EBR Systems announced that it received FDA approval for its wireless cardiac pacing device for heart failure. The FDA approved its WiSE cardiac resynchronization therapy (CRT) system through the premarket process. Australia-based EBR Systems — which has its U.S. base in Sunnyvale, California — says WiSE is the world’s only wireless cardiac pacing device for […]
CeriBell earns FDA nod for pediatric seizure detection software
CeriBell (Nasdaq:CBLL) announced today that it received FDA 510(k) clearance for its next-generation Ceribell Clarity algorithm. Clarity detects electrographic seizures in patients ages one and older. The company says this makes it the first and only AI-powered point-of-care electroencephalography (EEG) system cleared to detect electrographic seizures in patients at that age and to fully cover […]
Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment
Innoblative Designs announced today that it received FDA investigational device exemption (IDE) for its Sira RFA electrosurgical device. Chicago-based Innoblative Designs’ SIRA device holds FDA breakthrough device designation. It designed SIRA for use in breast cancer patients undergoing breast-conservation surgery (BCS/lumpectomy). SIRA uses radiofrequency ablation (RFA) through a unique spherical shape that circumferentially delivers RF energy. […]
