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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
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
Eyenuk’s EyeArt artificial intelligence (AI) system had a sensitivity of 96.4 percent in identifying more than mild diabetic retinopathy (mtmDR) while dilation eye exams had a 27.7 percent sensitivity in the identical study group, researchers reported at the American Academy of Ophthalmology's annual meeting in Chicago. Read More
Legislation to reauthorize the FDA’s user fee programs passed the House of Representatives on Friday in a vote of 230 to 201 as part of a continuing resolution (CR) to fund the federal government through Dec. 16. The CR passed in the Senate the night prior in a bipartisan vote of 72 to 25. Read More
Patients using Beta Bionics’ iLet Bionic Pancreas had an average lower blood glucose level and 11 percent more time in the target blood sugar range, according to study results published in the New England Journal of Medicine (NEJM).Read More
It is all too easy for a consumer or healthcare professional complaint about a drug or device to snowball into a nightmare of damaging publicity, recalls, regulatory fallout and even lawsuits from customers and shareholders. Prompt, careful and correct responses to complaints can mean the difference between a company avoiding these landmines or picking up the pieces after the explosion. Read More