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Flawless Beauty and Skin is importing and marketing unapproved devices, according to a warning letter the FDA sent the Ocean, N.J., firm following an inspection at that facility Nov. 16, 2021, through Jan. 19, 2022. Read More
Most machine learning-enabled medical devices are cleared by the FDA without efficacy demonstrated in a randomized clinical trial, researchers at the Harvard-MIT Health Sciences and Technology program reported in the journal JAMA Network Open. Read More
The FDA has released three final guidances spelling out its product review goals and timing under user fee commitments negotiated with industry for the Medical Device User Fee Amendments (MDUFA) program reauthorized by Congress on Sept. 30. Read More
The FDA handed American Contract Systems a Form 483 for validation issues and other quality lapses observed during an inspection of its Temple Terrace, Fla., facility April 5-8. Read More
A first-in-human feasibility trial of SpyGlass Pharma’s combination product to treat glaucoma led to a 45 percent drop in patients’ mean intraocular pressure at three months without the need for additional therapy, the company said at the American Academy of Ophthalmology annual meeting in Chicago. Read More
If exploited, an attacker could access patient information and obtain additional access to various services associated with Vitrea View, said Trustwave Spiderlabs. Read More
The new EU rules are “designed to improve product safety, ensuring greater openness, traceability and clinical safety evidence,” the company noted. Read More
The FDA rapped Zoll Medical in a Form 483 for not properly validating its processes and for inadequate controls at its Rumford, R.I., plant to ensure products conformed to specifications. Read More
The FDA expects to gain insights from the real-world perspective of Veterans Health Administration (VHA) clinicians and scientists under a newly announced collaboration between the agencies aimed at interoperable medical devices. Read More