Vaporized Hydrogen Peroxide Sterilization Gets FDA Established Category A Status
An Established Category A sterilization method has a long history of safe and effective use on medical devices, putting VHP on the same level as EtO and radiation.
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Continue Reading »Abbott launches first human trials of its pulsed field ablation system for afib as the sector grows
Abbott announced it has begun conducting the first human procedures using its new Volt system, through a study of more than 30 patients in Australia.
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Continue Reading »FDA approves Medtronic’s rechargeable deep brain stimulator for Parkinson’s, epilepsy and more
Barely a month after Medtronic announced the European clearance of its rechargeable Percept RC neurostimulator, it has racked up a U.S. approval, too.
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Continue Reading »Nanowear collects FDA OK for wearable AI blood pressure monitor
The maker of a wearable garment for tracking heart rate, breathing and physical activity has obtained an FDA clearance for artificial intelligence-powered software that enables continuous monitoring of blood pressure without an inflatable cuff.
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Continue Reading »FDA grants first clearance to AI program for diagnosing idiopathic pulmonary fibrosis
The AI developer Imvaria has claimed a de novo clearance from the FDA for a digital diagnostic that analyzes chest CT scans for the signs of IPF.
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Continue Reading »Congressional Watchdog to Launch Probe into FDA Medical Device Recall Oversight
Two prominent senators called for an inquiry into the agency’s handling of device recalls through an open letter published last month.
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Continue Reading »Cognito opens biomarker study of neuromod device for Alzheimer’s
As it races toward FDA review of its light- and sound-based neuromodulation device, Cognito Therapeutics is taking an even closer look at the tech.
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Continue Reading »FDA clears vibrating belt to boost brittle bones in women facing osteoporosis
The FDA has granted a clearance to its first prescription medical device to help treat low bone density, with a wearable vibrating belt designed for postmenopausal women.
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Continue Reading »FDA clears AI-powered handheld that checks moles for skin cancer
Designed for use by primary care providers, the noninvasive system can help identify melanoma, basal cell carcinoma and squamous cell carcinoma.
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Continue Reading »FDA, CMS issue joint letter supporting increased oversight of lab-developed tests
“CMS does not have the expertise to assure that tests work; the FDA does,” wrote leaders from both federal agencies.
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