wild casino ag bonus codes Wake up the ghosts! Texas, Texas A&M rivalry that dates to 1894 is rebornEarlier 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 .

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TAMPA, Fla. (AP) — Bucky Irving isn’t choosy. The rookie running back relishes any opportunity he gets to contribute to the success of the Tampa Bay Buccaneers, who have to climb back into a tie for first place in the NFC South. Irving leads NFL rookies in rushing with 732 yards, averaging 5.5 yards per carry while sharing the workload with starter Rachaad White and third-stringer Sean Tucker, who have combined to ease some of the burden on quarterback Baker Mayfield. A fourth-round draft pick out of Oregon, Irving is coming off rushing for a season-best 152 yards and a touchdown in last week’s 26-23 overtime win over the Carolina Panthers. He had another 33 yards receiving, giving him a rookie-leading 1,017 total yards from scrimmage through 12 games. The Bucs (6-6) on Sunday host the Las Vegas Raiders (2-10), who have an outstanding newcomer of their own with Brock Bowers on the verge of breaking the league’s record for catches by a rookie tight end. Bowers leads all players, regardless of position, with 84 receptions. He’s fourth with 884 yards receiving and second behind Irving among rookies with 895 total yards from scrimmage. “I don’t really like taking all the credit. It’s those guys up front,” Irving said, deferring to Tampa Bay’s improved offensive line. “I think I have to do something special for those guys for Christmas because they’re getting the job done.” The Bucs are eighth in the NFL in rushing at 137.2 yards per game. They’ve gained 100-plus yards on the ground in nine of 12 games after only doing it nine times in 34 games over the past two seasons. Irving, whose ability to make defenders miss and accelerate in the open field, has provided a spark to an offense that sputtered without injured wide receivers Mike Evans and Chris Godwin during a four-game losing streak. It doesn’t seem to bother the rookie that he still sits behind White on the depth chart. The starter had a 38-yard run in overtime to set up the winning field goal last week. Coach Todd Bowles continues to stress that the Bucs, tied with Atlanta for the NFC South lead, need both Irving and White to be successful. “In our room, all our success is one,” said Irving, who in the past two weeks became the first rookie since Miles Sanders in 2019 to string together consecutive games with 150-plus yards from scrimmage. “If I’m having success,’’ Irving added, “everybody in the room is having success.” Bracing for a challenge Tampa Bay’s porous secondary figures to be tested by Bowers, the first tight end to lead the league in catches after Week 13 since Todd Christenson in 1986. The first-round draft pick out of Georgia needs three receptions to break Sam LaPorta’s season record (86 in 2023) for catches by a tight end. He’s 116 yards away from joining Mike Ditka (1,076 in 1961) and Kyle Pitts (1,026 in 2021) as the only rookie tight ends to finish with 1,000-plus yards receiving. “I thought he was one of the best tight ends coming out in a long time – not just this draft, but in a long time,” Bowles said. “He’s living up to expectations. He can play wideout, he can play tight end, he can do some fullback, he can run jet sweeps,” the Bucs coach added. “They do a lot of things with him and he’s a very talented guy.” Getting ready for Baker The last time the Raiders went against Mayfield was two seasons ago when he came off a plane to play for the Los Angeles Rams. Despite having minimal time with the playbook and just one brief practice, Mayfield rallied the Rams to a 17-16 victory on a 23-yard touchdown pass with 10 seconds left. Raiders coach Antonio Pierce was the team’s linebackers coach at the time. “He plays the game kind of like Brett Favre, who I played against in (the) league,” Pierce said. “He’s very fiery. He’ll do whatever it takes to make a play. The play’s never dead with him. You’ve got to keep your eyes on him and then stay in coverage, so that’ll be a challenge.” Return to action Raiders quarterback Aidan O’Connell didn’t look as though he had missed nearly six weeks because of a broken thumb when he almost led Las Vegas to a victory at Kansas City last week. He completed 23 of 35 passes for 340 yards and two touchdowns in the Raiders’ 19-17 loss to the Chiefs. But O’Connell had a hard time looking at the positives given how close the Raiders came to beating the two-time defending Super Bowl champions. “Definitely some good plays, but it just stinks more than anything,” O’Connell said. “It was just a really hard loss. Even sometimes when you have a game right after, it’s easier to move on. But we had a longer week this week and so kind of really got to sit in it and it’s no fun.” ___ AP Sports Writer Mark Anderson in Las Vegas contributed to this report. ___ NFL:

Managed Security Services Market to Grow by USD 33.86 Billion (2024-2028), Cloud Adoption Drives Revenue, Report Highlights AI's Impact on Trends - TechnavioStock indexes drifted to a mixed finish on Wall Street as some heavyweight technology and communications sector stocks offset gains elsewhere in the market. The Standard & Poor’s 500 index slipped less than 0.1% on Thursday, its first loss after three straight gains. The Dow Jones industrial average added 0.1%, and the Nasdaq composite fell 0.1%. Trading volume was lighter than usual as U.S. markets reopened following the Christmas holiday. Chip company Broadcom rose 2.5%, Micron Technology climbed 1.3% and Adobe gained 0.8%. Although 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 slipped 0.4% and Netflix gave up 0.7%. Tesla was among the biggest decliners in the S&P 500, down 1.4%. Healthcare 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 climbed 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 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. Trading was expected to be subdued this week with a thin slate of economic data on the calendar. Still, U.S. markets have historically received 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. 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% this year and remains near its most recent all-time high it set earlier this month — its latest of 57 record highs this year. Veiga writes for the Associated Press. AP Business Writers Elaine Kurtenbach and Matt Ott contributed.

Each week, Yardbarker is monitoring the 2025 NFL Draft, scheduled for April 24-26 in Green Bay. From Ohio State's star-studded backfield to a Texas ballhawk, here are five players we are tracking. How are Ohio State stars Quinshon Judkins and TreVeyon Henderson distinguishing themselves as top RBs? In his Wednesday column, the Draft Network's Ryan Fowler noted Henderson and Judkins' attention to detail separates them from other RBs in the class. "Both players are household names thanks to their explosive talent," wrote Fowler. "However, what sets the two apart isn't just their natural ability to create with the ball in their hands, it's a dedication and attention to the finer aspects of the game that makes them such interesting case studies." Per Pro Football Focus , Henderson (5-foot-10, 208 pounds) and Judkins (6-foot, 219 pounds) have allowed zero sacks on 50 combined pass-block snaps in 10 games. The duo has 1,385 rushing yards collectively. The tandem must quash the Hoosiers' stingy run defense when Ohio State hosts Indiana on Saturday. Indiana — No. 5 in the College Football Playoff rankings — leads the Big Ten in rushing yards allowed (72.2). Indiana's Kurtis Rourke could be a sleeper QB Could Rourke — an Ontario, Canada native — be one of the most underrated QB prospects in the 2025 class? "In a top-heavy quarterback class for the 2025 NFL Draft, Indiana Hoosiers QB Kurtis Rourke is the unheralded sleeper who could turn into a legitimate starter at the next level," wrote The 33rd Team's Tyler Brooke on Thursday. The 6-foot-5, 223-pounder plays a pivotal role in Indiana's second-ranked scoring offense (43.9 PPG). Through nine starts, he has the FBS' second-best QBR (88.1) and is tied for the 16th-most TD passes (21). Per ESPN's Football Power Index , the Hoosiers' strength of schedule is 106th out of 134 FBS teams. Excelling against the No. 2 Buckeyes would prove Rourke isn't just dominating weak competition and should boost his stock. Colorado QB Shedeur Sanders' commitment to the East-West Shrine Bowl is significant On Wednesday , Sanders (6-foot-2, 215 pounds) accepted his invitation to the East-West Shrine Bowl, scheduled for Jan. 30 at AT&T Stadium. The annual college all-star game allows NFL clubs to scout top prospects before the draft. "The Colorado star would be wise to take every opportunity during the draft process to make his case for QB1 status and as a first-round prospect," wrote The Athletic's Dane Brugler . "Maybe even more important than what happens on the field, the Shrine Bowl will be an important week for Sanders as he interviews with NFL teams to answer any questions and sell himself." In September, a former general manager told The Athletic's Jim Trotter he had questions about Sanders' maturity and ability to bond with teammates. If he alleviates these concerns during Shrine Bowl interviews, some teams may tab the 22-year-old as their QB1. Through 10 starts, he ranks third in the FBS in completion percentage (72.9 percent) and is tied for second in TD passes (27). As of Thursday, ESPN's Football Power Index gives Colorado (8-2) the best chance (43.6 percent) to win the Big 12. Texas DB Jahdae Barron's impressive senior season has him climbing draft boards Returning for a fifth season is paying off for Barron (5-foot-11, 200 pounds). In 10 games, he has career highs in interceptions (four) and passes defensed (eight). "Jahdae Barron can play wide and in the slot," wrote Pro Football Focus' Trevor Sikkema , who ranked the Texas star as his No. 1 slot corner. "He was a high-impact player in the slot over the past two years and is now an interception machine on the outside." On Tuesday , the Jim Thorpe Award — given to the best DB in college football — named Barron a semifinalist for a second consecutive season. Barron is certainly an ascending prospect and could land in the first round. In his latest mock draft, ESPN's Matt Miller has the Green Bay Packers taking him with pick No. 26.Prime Minister Keir Starmer to meet John Swinney and other leaders in Scotland