Medtronic (NYSE:MDT) announced today the FDA approved its Intellis and Vanta neurostimulator for treating chronic pain. The approval covers the Intellis rechargeable neurostimulator and the Vanta recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy. The new indication offers DPN patients access to Medtronic’s spinal cord stimulation (SCS) portfolio of both […]
Pre-Market Approval (PMA)
FDA approves expanded labeling for Nevro spinal cord stimulation
Nevro (NYSE:NVRO) today said it received FDA approval for expanded labeling of its Senza spinal cord stimulations system to treat non-surgical refractory back pain (NSRBP). Redwood City, California–based Nevro designed the 10 kHz therapy to improve pain relief and reduce opioid use. The 12-month results from a study of the system showed that patients who […]
FDA approves Cochlear Nucleus Implant for unilateral hearing loss, single-sided deafness
Cochlear Ltd. (ASX:COH) today announced that it received FDA approval for extended applications of its Nucleus implants. Sydney, Australia-based Cochlear designed the Nucleus implants to treat unilateral hearing loss (UHL) and single-sided deafness (SSD). The implants were already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. UHL is characterized by hearing loss […]
Neovasc enrolls first patient in refractory angina treatment trial
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 […]
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 […]
