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NoneAVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable MarketCANCUN, Mexico (AP) — Brayon Freeman had 26 points in Bethune-Cookman's 79-67 victory over North Dakota on Tuesday night. Freeman added three steals for the Wildcats (2-4). Tre Thomas added 17 points while shooting 4 for 12 (4 for 5 from 3-point range) and 5 of 6 from the free-throw line while he also had six rebounds. Daniel Rouzan went 5 of 10 from the field to finish with 10 points. Javascript is required for you to be able to read premium content. Please enable it in your browser settings.
The Bold XPeng Plan! New Models and Record-Breaking MilestonesEarlier this week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) released its long-anticipated final guidance (the “Guidance”) on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence/machine learning (“AI/ML”) software. FDA’s stated goal for the Guidance is to “to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices,” and it represents notable progress in the Agency’s scramble to keep with – or at least prevent being too far outpaced by – the rapid pace of AI/ML innovation, as used in digital health technology. A. The AI Challenge FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical devices, including, more specifically, medical device modifications . Since the Medical Device Amendments of 1976, FDA has kept a relatively firm grasp on post-market device modifications by requiring manufacturers of legally-marketed devices that originally required 510(k) clearance, De Novo classification, or premarket approval (“PMA”) to submit a supplemental 510(k) notification, De Novo request, and/or approval application for post-market modifications that significantly change or modify the device design, components, method of manufacture, or intended use (i.e., modifications “that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device”).[1] However, regulating AI-DSF, which are designed to constantly self-modify, clearly requires a different approach. FDA has publicly contemplated such an approach since at least 2019, when it published its first discussion paper on the subject.[2] Now, almost six years later, FDA’s first final guidance is here. B. New PCCP Framework The Guidance begins by acknowledging that the development of AI-DSF is an “iterative process” and that its new PCCP framework is designed to provide a “reasonable assurance” of safety and effectiveness. Rather than requiring AI-DSF manufacturers to receive clearance and/or approval for significant modifications after a device is legally marketed, FDA will require that AI-DSF manufacturers include a PCCP with the initial marketing submission (i.e., 510(k) notification, De Novo request, or PMA application). As part of the pre-market review process, FDA will review the PCCP “to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.” Rather than review each modification as it occurs – which would be impossible to monitor and assess – FDA will review the human-defined objectives (i.e., algorithms) intended to guide the technology’s ongoing self-modifications. The Guidance outlines FDA’s recommendations on the content of a marketing submission for a AI-DSF PCCP, which generally includes: (i) a detailed description of the specific, planned device modifications (i.e., the “Description of Modifications”); (ii) the associated methodology to develop, validate, and implement those modifications in a manner that ensures the continued safety and effectiveness of the device across the intended use populations (i.e., the “Modification Protocol”); and (iii) the assessment of the benefits and risks of the planned modifications and risk mitigations (i.e., the “Impact Assessment”). At a lengthy 49 pages, the Guidance goes into granular detail on each of the three elements of a PCCP (i.e., Description of Modifications, Modification Protocol, and Impact Assessment) but caveats that manufacturers should not rely on the Guidance for a “a complete description of what may be necessary to include in a marketing submission for an AI-DSF” – that is, FDA is careful to clarify that the PCCP is only one piece of a marketing submission for an AI-DSF.[3] The PCCP requirement outlined in the Guidance is broad and applies to both automatic AI-DSF modifications (i.e., modifications that are implemented automatically by software, also known as “continuous learning”), and manual AI-DSF modifications (i.e., modifications involving steps that require human input, action, review, and/or decision-making and therefore are not implemented automatically). Although the Guidance does not explicitly state as much, it is presumed to apply to all future marketing submissions, as it does not include any indication that the requirement would apply retroactively. C. Looking Ahead There is no doubt that the fate of FDA policy, especially policy that is implemented solely through informal guidance (rather than notice-and-comment rulemaking) is a bit up in the air in the face of the incoming administration, which has promised big changes and is centered on a platform of de-regulation. In what may have been an attempt to insulate its new policy from reversal during the upcoming administration, the Guidance goes to great lengths to detail all of the stakeholder input that FDA received and considered in constructing the proposed framework between 2019 and 2024 – a move that we usually see when the Agency issues a final rulemaking, but is less common in informal guidances. However, given that FDA’s first discussion paper (addressing the need to regulate AI-DSF in digital health technology) was published during the previous Trump administration, coupled with the greater push to regulate AI across all industries, this is a rare subset of FDA’s regulatory scheme that could enjoy largely bipartisan support. It remains to be seen whether the upcoming administration will memorialize FDA’s PCCP policy via formal rulemaking, or whether regulators and other key stakeholders will, instead, call on Congress to set the policy for AI-DSF. Either way, the policy outlined in the new Guidance stands, at least for now, and manufacturers of medical devices that utilize AI/ML should begin integrating the preparation of Modification Descriptions, Modification Protocols, and Impact Assessments into their overall product development plans. FOOTNOTES [1] See 21 CFR 807.81(a)(3) . [2] See Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback . [3] See, e.g ., 21 CFR 807.87 , 21 CFR 860.220 , 21 CFR 814.20 .
Stock market today: Wall Street drifts to a mixed close in thin trading following a holiday pause Stock indexes drifted to a mixed finish on Wall Street as some heavyweight technology and communications sector stocks offset gains elsewhere in the market. The S&P 500 slipped less than 0.1% Thursday, its first loss after three straight gains. Alex Veiga, The Associated Press Dec 26, 2024 1:14 PM Share by Email Share on Facebook Share on X Share on LinkedIn Print Share via Text Message FIL:E - People photograph the New York Stock Exchange in New York's Financial District on Dec. 23, 2024. (AP Photo/Peter Morgan, File) Stock indexes drifted to a mixed finish on Wall Street as some heavyweight technology and communications sector stocks offset gains elsewhere in the market. The S&P 500 slipped less than 0.1% Thursday, its first loss after three straight gains. The Dow Jones Industrial Average added 0.1%, and the Nasdaq composite fell 0.1%. Gains by retailers and health care stocks helped temper the losses. Trading volume was lighter than usual as U.S. markets reopened following the Christmas holiday. The Labor Department reported that U.S. applications for unemployment benefits held steady last week, though continuing claims rose to the highest level in three years. Treasury yields fell in the bond market. THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below. Stocks wavered on Wall Street in afternoon trading Thursday, as gains in tech companies and retailers helped temper losses elsewhere in the market. The S&P 500 was up less than 0.1% after drifting between small gains and losses. The benchmark index is coming off a three-day winning streak. The Dow Jones Industrial Average was up 10 points, or less than 0.1%, as of 3:20 p.m. Eastern time. The Nasdaq composite was up 0.1%. Trading volume was lighter than usual as U.S. markets reopened after the Christmas holiday. Chip company Broadcom rose 2.5%, Micron Technology was up 1.3% and Adobe gained 0.8%. While tech stocks overall were in the green, some heavyweights were a drag on the market. Semiconductor giant Nvidia, whose enormous valuation gives it an outsize influence on indexes, slipped 0.1%. Meta Platforms fell 0.5%, Amazon was down 0.4%, and Netflix gave up 0.7%. Tesla was among the biggest decliners in the S&P 500, down 1.4%. Health care stocks helped lift the market. CVS Health rose 1.4% and Walgreens Boots Alliance rose 3.9% for the biggest gain among S&P 500 stocks. Several retailers also gained ground. Target rose 3.1%, Ross Stores added 1.8%, Best Buy was up 2.5% and Dollar Tree gained 3.6%. Traders are watching to see whether retailers have a strong holiday season. The day after Christmas traditionally ranks among the top 10 biggest shopping days of the year, as consumers go online or rush to stores to cash in gift cards and raid bargain bins. U.S.-listed shares in Honda and Nissan rose 4.2% and 15.9%, respectively. The Japanese automakers announced earlier this week that the two companies are in talks to combine. Traders got a labor market update. U.S. applications for unemployment benefits held steady last week , though continuing claims rose to the highest level in three years, the Labor Department reported. Treasury yields turned mostly lower in the bond market. The yield on the 10-year Treasury fell to 4.58% from 4.59% late Tuesday. Major European markets were closed, as well as Hong Kong, Australia, New Zealand and Indonesia. Trading was expected to be subdued this week with a thin slate of economic data on the calendar. Still, U.S. markets have historically gotten a boost at year’s end despite lower trading volumes. The last five trading days of each year, plus the first two in the new year, have brought an average gain of 1.3% since 1950. So far this month, the U.S. stock market has lost some of its gains since President-elect Donald Trump’s win on Election Day, which raised hopes for faster economic growth and more lax regulations that would boost corporate profits. Worries have risen that Trump’s preference for tariffs and other policies could lead to higher inflation , a bigger U.S. government debt and difficulties for global trade. Even so, the U.S. market remains on pace to deliver strong returns for 2024. The benchmark S&P 500 is up roughly 26% so far this year and remains near its most recent all-time high it set earlier this month — its latest of 57 record highs this year. Wall Street has several economic reports to look forward to next week, including updates on pending home sales and home prices, a report on U.S. construction spending and snapshots of manufacturing activity. ___ AP Business Writers Elaine Kurtenbach and Matt Ott contributed. Alex Veiga, The Associated Press See a typo/mistake? Have a story/tip? This has been shared 0 times 0 Shares Share by Email Share on Facebook Share on X Share on LinkedIn Print Share via Text Message More National Business Boxing Day shoppers take advantage of tax holiday amid cost of living crisis Dec 26, 2024 12:08 PM Israel strikes Houthi rebels in Yemen's capital while the WHO chief says he was meters away Dec 26, 2024 10:25 AM Canada’s women’s pro sports landscape transformed with arrival of PWHL, NSL and WNBA Dec 26, 2024 8:50 AM Featured FlyerALBANY, N.Y. – Governor Kathy Hochul has signed legislation that will increase the accessibility of home heating aid and help identify more seniors who are eligible for the Home Energy Assistance Program. HEAP is a federal program available to New Yorkers that helps low-income homeowners and renters afford costs associated with heating and cooling. Through this legislation, applicants and participants of the Elderly Pharmaceutical Coverage Program will be provided information and instructions for enrollment in HEAP. Applications for the Regular HEAP benefit opened November 1. Details on eligibility and links to apply can be found https://mybenefits.ny.gov/mybenefits/begin. Seniors who require assistance filling out their HEAP applications can contact their local office for the aging or the NY Connects helpline at 1-800-342-9871. The Madison County Office of the Aging: 138 Dominic Bruno Blvd, Canastota, 315-697-5700. Other resources: Herkimer County DSS 301 N. Washington St., Ste. 2110, Herkimer, 315-867-1291. Madison County DSS N. Court St. Bldg. 1, Wampsville, 315-366-2211. Oneida County DSS: 800 Park Ave., Utica, 315-798-5700. “Programs like HEAP help put money back in the pockets of hard-working New Yorkers, helping heat their homes in the dead of winter,” Hochul said. “From raising the minimum wage to our proposed inflation refund checks, we’re doing everything we can to tackle the affordability crisis head-on.” The legislation relates to the provision of HEAP information to EPIC program participants. The New York State Department of Health oversees EPIC and its applications. The department will provide HEAP information and enrollment information with each EPIC application and also through an annual notice to EPIC participants. Hochul has worked to expand coverage and funding for New Yorkers to receive heating assistance this winter. On Nov. 12, she announced that additional funding was available for seniors and low- and middle-income households to help lower their heat and energy bills. HEAP can provide up to $996 to eligible households and has put over $397 million back in the pockets of New Yorkers. “Governor Hochul understands that having a safe and comfortable home, protected from the elements, is a social determinant of health that is foundational to improved health outcomes,” New York State Health Commissioner Dr. James McDonald said. “New York sees some of the coldest temperatures during the winter and this important legislation will ensure New York’s most vulnerable senior citizens are safeguarded from the cold without facing the added costs of heating their homes.”