Neovasc (NSDQ:NVCN) announced today that it enrolled the first patient in the Cosira-II clinical trial for its Neovasc Reducer. Vancouver, Canada-based Neovasc’s Cosira-II (coronary sinus reducer for the treatment of refractory angina) pivotal trial will study the safety and effectiveness of the Reducer in reducing angina symptoms in those with refractory angina. According to a […]
Pre-Market Approval (PMA)
Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’
Senseonics (NYSE:SENS) announced that it anticipates the FDA to decide within weeks on approval of its new CGM system. The company seeks a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy. The next-generation Eversense matched performance levels compared to the current […]
FDA approves Urotronic’s Optilume drug coated balloon for urethral strictures
Urotronic today announced that it received FDA approval for its Optilume urethral drug-coated balloon for male urethral strictures. Plymouth, Minnesota–based Urotronic designed the paclitaxel-coated balloon to inhibit new scar tissue growth that can occur after endoscopic dilations. Urethral strictures are scars in or around the urethra that can restrict urine flow from the bladder. Get […]
The advantages of an AI/ML-enabled search engine for FDA records
The FDA’s new list of artificial intelligence and machine learning-enabled devices highlights opportunity for improvement. Craig Coombs and Qiang Kou, Nyquist Data The FDA released a list of cleared or approved artificial intelligence and machine learning-enabled devices in September, documenting much of the agency’s work in the innovative area of AI/ML. Extracting this information from […]
Delphinus wins FDA approval for whole breast ultrasound tomography system
Delphinus Medical Technologies announced today that it received FDA premarket approval (PMA) for its SoftVue system. Novi, Michigan-based Delphinus develops the SoftVue 3D whole breast ultrasound tomography system for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue, according to a news release. The company said SoftVue […]
FDA issues final rule to make de novo classification process easier
The FDA has issued a final rule aimed at simplifying the de novo classification process for medical devices. In publishing the final rule yesterday, the FDA established procedures and criteria for submitting and withdrawing a de novo request while also setting guidelines for the FDA to decide on such a request. The changes matter because […]
Abbott wins FDA approval for next-gen Amplatzer Talisman
Abbott (NYSE:ABT) announced today that the FDA has approved its Amplatzer Talisman PFO occlusion system for stroke prevention. In addition, the FDA cleared the Amplatzer Talisman delivery sheath. The Amplatzer Talisman is a next-generation version of the company’s Amplatzer PFO occluder, originally approved in 2016. The Talisman has an additional 30 mm device size, and […]
FDA approves Transmedics’ OCS Liver preservation system
TransMedics (NSDQ:TMDX) today announced that it has received FDA premarket approval for its OCS Liver system for use with organs from donors after brain death and circulatory death. Andover, Massachusetts–based Transmedics designed the device to preserve and monitor the hemodynamics and metabolic function. It allows for ex-vivo assessment of liver allografts from brain dead and circulatory […]
Abbott enters U.S. TAVR market with FDA approval of its Portico with FlexNav
Abbott (NYSE:ABT) today announced U.S. FDA approval of its Portico with FlexNav TAVR system. The approval launches Abbott into a U.S. TAVR space that Edwards Lifesciences and Medtronic have dominated. (Check out our recent DeviceTalks Weekly podcast that recounted Edwards Lifesciences’ pioneering work in the space.) Boston Scientific is out of the TAVR market for […]
FDA approves TransMedics’ OCS Heart system
TransMedics (NSDQ:TMDX) announced today that it received FDA premarket approval for its OCS Heart system. Andover, Massachusetts-based TransMedics designed its OCS Heart system for use with organs from donors after brain death with indication for preserving donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic […]
Glaukos submits supplemental PMA application for iStent Infinite
Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system. San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy. Get […]