The FDA said today it wants to hear from surgical mask and gown manufacturers that might be able to increase or speed production to prevent shortages in the U.S. during the COVID-19 outbreak. The agency said it may expedite review of manufacturing site changes or premarket submissions of personal protective equipment, including protective clothing, gowns, […]
CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system
CardioFocus is seeking a PMA supplement with FDA so that it can launch its next-gen HeartLight X3 endoscopic ablation system in the U.S. The move comes more than 10 months after Marlborough, Mass.–based won a CE Mark in Europe for the device, which is used to treat AFib. CardioFocus plans to launch HeartLight X3 in […]
Contura wins FDA premarket approval for hydrogel injection
Contura announced that it won FDA premarket approval for its Bulkamid hydrogel injection for treating stress urinary incontinence (SUI). Bulkamid is Contura’s proprietary device designed for treating SUI due to intrinsic sphincter deficiency in adult women with SUI or stress predominant mixed incontinence. According to a news release, the product is currently marketed in more […]
Abbott wins expanded indication for Infinity DBS system
Abbott (NYSE:ABT) today announced FDA approval of an expanded indication for the company’s Infinity deep brain stimulation system. Abbott boasts that Infinity is now the only directional DBS system approved for all major targets used to treat movement disorders, Parkinson’s disease and essential tremor. The new indication is for targetting the brain’s internal globus pallidus (GPi), […]
BREAKING: Medtronic wins FDA approval for Micra AV
Medtronic (NYSE:MDT) has won FDA approval for its Micra AV — greatly expanding the number of people who could potentially benefit from leadless pacemaker technology. The medical device giant plans to start offering the Micra AV in a limited number of implanting centers in the coming weeks, with a full launch expected in the spring. FDA […]
Neovasc Reducer gains FDA PMA review
Neovasc said it received FDA administrative acceptance review notification for its Reducer device. Reducer is designed to treat refractory angina, which occurs when the coronary arteries deliver an inadequate supply of blood to the heart. “I would like to reiterate my thanks to the entire Neovasc team for their tireless efforts to complete the submission […]
Abbott LVAD wins FDA approval for implantation without open heart surgery
Abbott (NYSE:ABT) today announced that FDA has approved implantation of its HeartMate 3 LVAD via lateral thoracotomy — a less invasive approach than open-heart surgery. The approval comes about a year and a half after Medtronic (NYSE:MDT) won a similar approval for the competing HeartWare HVAD pump. Lateral thoracotomy involves a surgeon making an incision between a person’s […]
Medtronic wins dismissal of Pennsylvania couple’s DBS lawsuit
Medtronic has prevailed in a personal injury lawsuit over a deep-brain stimulation implant approved by the FDA to treat neurological disorders. A federal judge in Philadelphia on Monday granted the company’s motion to dismiss the lawsuit filed by Edward Walls and his wife, Tonya Chavis-Walls. The couple had claimed in Pennsylvania state court that two […]
FDA approves Medtronic balloon to treat lesions hindering dialysis
Medtronic (NYSE:MDT) has secured FDA approval for its IN.PACT AV paclitaxel-coated balloon, meant to treat reoccurring blood vessel narrowing that delays people with end-stage renal disease from receiving needed dialysis. “In many cases, AV fistula are considered lifelines for patients with [end-stage renal disease] as they are the primary access point for life-saving dialysis treatment. When […]
FDA approves CooperVision’s contact lens to slow nearsightedness in kids
The FDA has approved the first contact lens indicated to slow the progression of nearsightedness in children between the ages of 8 and 12 years old. The MiSight contact by CooperCompanies’ (NYSE:COO) CooperVision lens is a single-use, disposable, soft contact lens that is discarded at the end of each day and is not intended to be worn […]
Axonics wins FDA approval for sacral neuromodulation device
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA premarket approval for its r-SNM sacral neuromodulation system for the treatment of overactive bladder and urinary retention. The implantable, rechargeable sacral neuromodulation device is the first of its kind approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device […]
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