Teva Pharmaceuticals USA Inc.’s quest to get the U.S. Supreme Court to overturn the Federal Circuit and preserve label carveouts, or so-called skinny labels, continued Oct. 3 with the high court asking the solicitor general to weigh in.
The American Academy of Ophthalmology (AAO) annual meeting in Chicago Sept. 30 to Oct. 3 covered the waterfront in the ophthalmic market, with positive signs for continued or improving health as supply kinks work out. Hurricane Ian’s impact on the other side of the country was also a topic, as Florida accounts for a disproportionate percentage of cataract surgeries, which may be delayed as a result of the destruction in the state. We provide some highlights from the conference, analysts’ meetings with company executives and some timely new developments in the sector.
The U.S. Congress passed a five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system's implementation in 2002, after many months of back and forth with the med-tech industry. The extension passed as part of a temporary spending bill needed to avoid a partial government shutdown ahead of Friday’s deadline. The spending bill passage gives lawmakers a reprieve until after the midterm elections when they'll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023.
Stryker Corp. reported the launch of its Q Guidance system for spine applications. The system leverages new optical tracking options via a redesigned camera with the advanced algorithms of the newly released Spine Guidance software.
The individual and population-level health impact of type 2 diabetes is well documented, a fact which recently drove the U.S. Preventive Services Task Force (USPSTF) to ask whether screening among asymptomatic individuals aged younger than 18 years would be worth the effort. The answer is that the task force simply does not know, simply because the agency’s literature search turned up no studies that prospectively evaluated the benefits of screening in this population, signaling a missed opportunity for drug and device makers to intervene in this massively costly disease.
The saga of U.S. FDA regulation of clinical decision support (CDS) software has spanned six years since the passage of the 21st Century Cures Act, yielding two FDA draft guidances and a final guidance that emerged only Sept. 27, 2022. Regulatory attorney Brad Thompson blasted the final guidance for its addition of “time-critical decision making” to the definition of a regulated medical device, one of several features he argued are extra-statutory and which effectively handcuff both developers of CDS and the physicians who use their products to aid in selecting drug and device treatments.
The COVID-19 pandemic may or may not be over, depending on which member of the U.S. government’s executive branch one asks, but the FDA’s device center has drawn much tighter lines around its emergency use authorization (EUA) program for COVID-19 tests.
As part of its obligations under the 21st Century Cures Act, the U.S. FDA is proposing two new rules to harmonize sections of its regulations on human subject protection and institutional review boards with the revised Common Rule, which provides for the protection of human subjects in federally funded research.
Clearpoint Neuro Inc. said Clinical Laserthermia Systems AB (CLS), snared a 510(k) from the FDA for a laser interstitial therapy system that will be marketed in the U.S. as part of the Clearpoint Prism Neuro system. This product package adds to a growing Clearpoint footprint in the neurological disorders space, adding to an inventory that already consists of targeted drug delivery and deep brain stimulation systems.
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