Tariff-driven disruptions in regulatory compliance
When tariffs are imposed on imported materials or components, manufacturers may be forced to adjust their supply chains, either by switching suppliers, modifying components or relocating production facilities. While these changes may be necessary to maintain cost efficiency, they often result in regulatory consequences.
The US Food and Drug Administration requires that manufacturers submit new 510(k) notifications or supplements to existing approvals if there are significant modifications to a device's design, materials or manufacturing process. Even small changes in internal circuitry may require revalidation and regulatory resubmission, delaying product availability and increasing compliance costs. For example, for companies such as Medtronic in the diabetes care space, where 88.89% of diabetes care devices are wholly manufactured in the US, the immediate exposure to tariffs may be lower but the broader impact is still felt. Many components or raw materials may still be imported and subject to tariffs, creating potential bottlenecks and compliance triggers if alternatives are introduced.
Companies operating internationally must also consider how such changes affect their regulatory obligations in multiple jurisdictions. An adjustment made in response to tariffs may require parallel filings with the European, Canadian or other global authorities. This multiplies administrative workload and extends timelines, diverting resources away from innovation and toward compliance maintenance. Abbott Laboratories offers a clear example of these tariff pressures. With key components of its FreeStyle Libre CGM system manufactured abroad, the company experienced cost hikes following US-China tariff escalations. In response, Abbott began exploring US-based production alternatives to mitigate trade exposure. However, this shift required regulatory revalidations and documentation updates for multiple global markets, straining internal compliance resources and delaying enhancements to its product pipeline.
In essence, tariffs, though designed as economic tools, have ripple effects that extend deeply into the regulatory framework of the medical device sector. Maintaining compliance while navigating supply chain disruptions and evolving trade landscapes requires strategic agility. Balancing innovation, cost containment and regulatory integrity has become increasingly complex, particularly for multinational manufacturers striving to ensure uninterrupted access to life-sustaining technologies.
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'While we are very optimistic with ... growth opportunities, we have also seen disruptions in federal contracts from efficiency efforts this quarter, most notably in programs that support the U.S. Army, as they seek to consolidate and modernize their data architecture and in turn, we have adjusted our full-year guidance this quarter to reflect these disruptions,' CEO Kevin McAleenan said in the earnings release. Listen to earnings call live on the stock page. (BBAI) stock tumbled 20% after the company reported a wide earnings and revenue miss and lowered its revenue guidance. Here's what the AI software firm reported compared to estimates, according to S&P Global Market Intelligence: BigBear, which provides software to the US government, noted that Department of Government Efficiency (DOGE) cuts weighed on the business. 'While we are very optimistic with ... growth opportunities, we have also seen disruptions in federal contracts from efficiency efforts this quarter, most notably in programs that support the U.S. Army, as they seek to consolidate and modernize their data architecture and in turn, we have adjusted our full-year guidance this quarter to reflect these disruptions,' CEO Kevin McAleenan said in the earnings release. Listen to earnings call live on the stock page. Plug Power stock falls on earnings miss Primary hydrogen player Plug Power (PLUG) continues to grow its top line, but a larger-than-expected loss disappointed in the second quarter. Plug Power reported a $0.20 loss per share, a wider loss than the $0.15 per share Wall Street expected, according to S&P Global Market Intelligence. The company posted $174 million in revenue, a 21% increase year over year, above estimates for $157 million, and on the high end of its previous forecast for between $140 million and $180 million in Q2 revenue. The company's gross margin remained negative at -31%, though it marked an improvement from the -92% margin in the same quarter a year ago. Plug Power said it expects to achieve breakeven in its gross margin run rate in Q4 2025. Plug also held $140 million in unrestricted cash and cash equivalents at the end of the quarter. The stock fell more than 5% in after-hours trading. Year to date, the stock is down 25%, though investors grew more bullish on the stock in July following the passage of the One Big Beautiful Bill Act, which Plug Power called "a major policy win." The tax and spending law extended the hydrogen production tax credit, providing a 30% credit on fuel cell purchases and more certainty to the industry. Listen to the earnings call live here. Primary hydrogen player Plug Power (PLUG) continues to grow its top line, but a larger-than-expected loss disappointed in the second quarter. Plug Power reported a $0.20 loss per share, a wider loss than the $0.15 per share Wall Street expected, according to S&P Global Market Intelligence. The company posted $174 million in revenue, a 21% increase year over year, above estimates for $157 million, and on the high end of its previous forecast for between $140 million and $180 million in Q2 revenue. The company's gross margin remained negative at -31%, though it marked an improvement from the -92% margin in the same quarter a year ago. Plug Power said it expects to achieve breakeven in its gross margin run rate in Q4 2025. Plug also held $140 million in unrestricted cash and cash equivalents at the end of the quarter. The stock fell more than 5% in after-hours trading. Year to date, the stock is down 25%, though investors grew more bullish on the stock in July following the passage of the One Big Beautiful Bill Act, which Plug Power called "a major policy win." The tax and spending law extended the hydrogen production tax credit, providing a 30% credit on fuel cell purchases and more certainty to the industry. Listen to the earnings call live here. stock falls 24% on sales miss, CEO health struggles Inc. (AI) stock tumbled as much as 30% after the software company reported a steep sales miss that it attributed to its founder's health issues. Bloomberg reports: Read more here. Inc. (AI) stock tumbled as much as 30% after the software company reported a steep sales miss that it attributed to its founder's health issues. Bloomberg reports: Read more here. Micron raises forecast, stock pops Micron Technology (MU) stock rose around 4% in early trading on Monday after the semiconductor company raised its forecast for fourth-quarter revenue and adjusted profit, citing surging demand for its memory chips used in artificial intelligence infrastructure. Micron is expected to reported fiscal fourth quarter earnings on Sept. 24. Read more here. Micron Technology (MU) stock rose around 4% in early trading on Monday after the semiconductor company raised its forecast for fourth-quarter revenue and adjusted profit, citing surging demand for its memory chips used in artificial intelligence infrastructure. Micron is expected to reported fiscal fourth quarter earnings on Sept. 24. Read more here. AMC tops revenue estimates as blockbuster titles boost theater attendance AMC (AMC) stock jumped 8.8% in premarket trading after the movie theater chain reported attendance in the second quarter grew nearly 26% as blockbusters drew in moviegoers. The company also reported a narrower-than-expected loss per share of $0.01, compared to estimates of a loss of $0.06 per share. Reuters reports: Read more here. AMC (AMC) stock jumped 8.8% in premarket trading after the movie theater chain reported attendance in the second quarter grew nearly 26% as blockbusters drew in moviegoers. The company also reported a narrower-than-expected loss per share of $0.01, compared to estimates of a loss of $0.06 per share. Reuters reports: Read more here. stock tanks following earnings (MNDY) stock fell as much as 20% after the project management software company missed earnings estimates. In the second quarter, reported earnings of $0.03 per share and revenue of $299 million. While revenue beat analyst expectations of $293 million, GAAP profits fell short, as Wall Street was looking for $0.20 per share, per S&P Global Market Intelligence. Investors have been looking for signs that economic uncertainty is pushing companies to pull back their spending on technology and software. The Israeli-based company's operating loss fell to $11.6 million from $1.8 million a year ago, and the operating margin fell to negative 4% from 1% last year. kept its full-year forecast roughly the same. It expects total revenue to grow about 26% to a range of $1.224 billion to $1.229 billion in 2025. 'This quarter demonstrated our relentless focus on driving highly efficient growth at scale, and I'm energized by the momentum in our business and the opportunities we see ahead,' CFO Eliran Glazer said in the earnings release. 'As we navigate the shifting landscape, we remain focused on the factors we can control — executing on our innovation roadmap, bolstering our go-to-market efforts to serve customers of all sizes, driving best-in-class operational efficiencies, and delivering products people love.' (MNDY) stock fell as much as 20% after the project management software company missed earnings estimates. In the second quarter, reported earnings of $0.03 per share and revenue of $299 million. While revenue beat analyst expectations of $293 million, GAAP profits fell short, as Wall Street was looking for $0.20 per share, per S&P Global Market Intelligence. Investors have been looking for signs that economic uncertainty is pushing companies to pull back their spending on technology and software. The Israeli-based company's operating loss fell to $11.6 million from $1.8 million a year ago, and the operating margin fell to negative 4% from 1% last year. kept its full-year forecast roughly the same. It expects total revenue to grow about 26% to a range of $1.224 billion to $1.229 billion in 2025. 'This quarter demonstrated our relentless focus on driving highly efficient growth at scale, and I'm energized by the momentum in our business and the opportunities we see ahead,' CFO Eliran Glazer said in the earnings release. 'As we navigate the shifting landscape, we remain focused on the factors we can control — executing on our innovation roadmap, bolstering our go-to-market efforts to serve customers of all sizes, driving best-in-class operational efficiencies, and delivering products people love.' Earnings have been mostly solid According to FactSet's tally, 90% of S&P 500 companies have reported second quarter earnings so far, meaning the end of earnings season is in sight (though certainly not complete until Nvidia's (NVDA) report on Aug. 27). It's been a good earnings season: More than 8 in 10 companies have reported both a positive earnings per share surprise and a positive revenue surprise. Some other key updates from FactSet's senior earnings analyst John Butters: Read more here. According to FactSet's tally, 90% of S&P 500 companies have reported second quarter earnings so far, meaning the end of earnings season is in sight (though certainly not complete until Nvidia's (NVDA) report on Aug. 27). It's been a good earnings season: More than 8 in 10 companies have reported both a positive earnings per share surprise and a positive revenue surprise. Some other key updates from FactSet's senior earnings analyst John Butters: Read more here. Wendy's gloomy 2025 outlook sends shares lower Wendy's beat Wall Street's estimates on the top and bottom lines on Friday; however, the company issued a weaker full-year financial outlook, sending shares about 1% lower in premarket trading. This year, the company sees adjusted earnings per share in a range of $0.82 to $0.89, lower than its previous forecast of $0.92 to $0.98. Global systemwide sales are also now projected to come in lower than previously expected for a decline of 3% to 5%, compared to the previous outlook of flat sales to a 2% decline. In the second quarter, sales decreased 1.8% to $3.7 billion, led by a 3.3% decline in the US market. The fast food chain reported revenue of $560.9 million, topping estimates of $558 million. Earnings per share were $0.29, also a beat against estimates of $0.25 per share. On Wednesday, McDonald's (MCD) reported a return to sales growth after economic uncertainty and inflation weighed on consumers and eroded the restaurant chain's value perception. Listen to the earnings call live here. Wendy's beat Wall Street's estimates on the top and bottom lines on Friday; however, the company issued a weaker full-year financial outlook, sending shares about 1% lower in premarket trading. This year, the company sees adjusted earnings per share in a range of $0.82 to $0.89, lower than its previous forecast of $0.92 to $0.98. Global systemwide sales are also now projected to come in lower than previously expected for a decline of 3% to 5%, compared to the previous outlook of flat sales to a 2% decline. In the second quarter, sales decreased 1.8% to $3.7 billion, led by a 3.3% decline in the US market. The fast food chain reported revenue of $560.9 million, topping estimates of $558 million. Earnings per share were $0.29, also a beat against estimates of $0.25 per share. On Wednesday, McDonald's (MCD) reported a return to sales growth after economic uncertainty and inflation weighed on consumers and eroded the restaurant chain's value perception. Listen to the earnings call live here. Trade Desk tumbles after CEO warns of tariff impact on large brand advertisers Trade Desk (TTD) stock fell by a third during premarket trading on Friday — putting it on track to wipe roughly $12 billion from its market cap — after CEO Jeff Green warned that tariff uncertainty began to weigh on some leading global advertisers. Reuters reports: The Trade Desk's second quarter earnings of $0.18 per share were in line with analyst estimates. Revenue of $694 million beat analyst estimates of $686 million, according to S&P Global Market Intelligence. The company expects third quarter revenue of at least $717 million, roughly in line with estimates. Read more here. Trade Desk (TTD) stock fell by a third during premarket trading on Friday — putting it on track to wipe roughly $12 billion from its market cap — after CEO Jeff Green warned that tariff uncertainty began to weigh on some leading global advertisers. Reuters reports: The Trade Desk's second quarter earnings of $0.18 per share were in line with analyst estimates. Revenue of $694 million beat analyst estimates of $686 million, according to S&P Global Market Intelligence. The company expects third quarter revenue of at least $717 million, roughly in line with estimates. Read more here. SoundHound stock soars on record revenue fueled by AI, automation demand SoundHound AI (SOUN) reported record revenue in its second quarter results, as its expansion into new verticals, such as restaurants and hospitals, helped fuel 217% year-over-year revenue growth. The stock rocketed 24% higher in premarket trading on Friday. SoundHound develops artificial intelligence solutions that businesses use for automation and to create conversational experiences for their customers. In Q2, SoundHound reported strong growth in its automation, automotive, and enterprise AI for customer service verticals. The company posted a GAAP loss of $0.19 per share on $42.7 million in revenue. Last year, SoundHound reported a loss of $0.11 per share and revenue of $13 million. SoundHound also raised its 2025 revenue outlook to $160 million to $178 million, up from its previous forecast of $157 million to $177 million. "The investments we are making are already showing high returns," SoundHound CFO Nitesh Sharan said on the company's earnings call. Sharan noted that the company sees a path to profitability "in the near-term horizon. Listen to the earnings call here. SoundHound AI (SOUN) reported record revenue in its second quarter results, as its expansion into new verticals, such as restaurants and hospitals, helped fuel 217% year-over-year revenue growth. The stock rocketed 24% higher in premarket trading on Friday. SoundHound develops artificial intelligence solutions that businesses use for automation and to create conversational experiences for their customers. In Q2, SoundHound reported strong growth in its automation, automotive, and enterprise AI for customer service verticals. The company posted a GAAP loss of $0.19 per share on $42.7 million in revenue. Last year, SoundHound reported a loss of $0.11 per share and revenue of $13 million. SoundHound also raised its 2025 revenue outlook to $160 million to $178 million, up from its previous forecast of $157 million to $177 million. "The investments we are making are already showing high returns," SoundHound CFO Nitesh Sharan said on the company's earnings call. Sharan noted that the company sees a path to profitability "in the near-term horizon. Listen to the earnings call here. Under Armour forecasts downbeat quarterly sales, shares drop Under Armour (UA) stock slumped by 12% before the bell on Friday after the sportswear maker forecast second-quarter revenue below Wall Street estimates. The company is grappling with muted demand in North America due to still-high inflation and tariff uncertainty. Reuters reports: Read more here. Under Armour (UA) stock slumped by 12% before the bell on Friday after the sportswear maker forecast second-quarter revenue below Wall Street estimates. The company is grappling with muted demand in North America due to still-high inflation and tariff uncertainty. Reuters reports: Read more here. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Bloomberg
13 minutes ago
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How China Is Bringing Hong Kong's IPO Market Back to Life
Never miss an episode. Follow The Big Take Asia podcast today. After a years-long slump, Hong Kong's IPO market is roaring back to life, thanks to a growing number of Chinese companies that are raising billions of dollars in the city.
