Voluntary recall notifies Medtronic insulin pump users of potential risk of shortened battery life

 Customers are being notified of the importance of checking built-in alerts and alarms for battery status and to contact Medtronic for pump replacement if affected by this issue

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump. Medtronic began investigating this issue upon receiving customer reports of shortened battery life and a comprehensive analysis found that pumps that have been dropped, bumped, or experienced physical impact even once may result in shortened battery life due to damage to internal electrical components. This electrical issue also causes battery alerts to occur when less battery life remains than the User Guide states. This may result in the pump stopping insulin delivery significantly sooner than usually expected and could lead to health risks like hyperglycemia or diabetic ketoacidosis (DKA), potentially requiring medical intervention. Most recently, Medtronic has received 170 reports of hyperglycemia >400mg/dL and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US potentially related to this issue. The FDA has classified this action as a class I recall.

https://www.prnewswire.com/news-releases/voluntary-recall-notifying-medtronic-insulin-pump-users-of-potential-risks-of-shortened-pump-battery-life-302267456.html

After Helene: in North Carolina, most find they're uninsured

 Few of the North Carolina victims of Hurricane Helene will have help from federal insurance to rebuild.

A Reuters analysis of government data shows only around 1 in 200 people in the state’s flood-stricken west are covered by the National Flood Insurance Program.

That’s a far lower rate than the coastal or riverside areas it’s meant to serve.

The Brosseaus, living near Asheville, weren’t among the insured.

"It came up to here. I'm surprised it didn't come through the windows. I mean it was pretty close, and the water was coming up from that way, which nobody would have expected that."

Pamela Brousseau and her husband were beginning a long clean-up job on Thursday.

"I cried. I still cry. You walk into a place that you know what it looks like and then it's not there. It's pretty hard, but thankful that we had, you know, ourselves here to take care of things, to assess it, and I don't know, it was pretty hard."

When they first moved in, the two were required to have flood insurance

But after three years, Libre, Pamela’s husband, said the flood maps were redrawn and their home was no longer required to have it.

“…we were no longer included in the flood plain, the 100-year flood plain. There was mention of a thousand-year flood plain. But at any rate, the requirement of the bank was no longer mandatory to have the flood insurance. We're not wealthy people, so we opted out of that coverage."

The insurance wasn't required because the federal program is mostly focused on the flood risks posed by rising seas and swelling rivers.

It doesn’t anticipate the threat posed by the sort of extreme rainfall brought on by Helene.

Asheville is the largest city in the area.

It had actually gotten a reputation as a climate refuge in recent years – with people moving there from storm-prone areas.

The federal government even moved its national data center for environment records there.

And private insurance companies see the area as relatively safe.

The industry asked state regulators earlier this year to approve a 99% rate increase for coastal areas, but only asked for a 4% hike for some of the mountain counties that Helene went on to hit.

Yet as the storm approached, insurance was very much on the Brosseaus’ minds.

"Yeah, it is. It was probably one of the first things we discussed as the storm was coming. Like holy crap. But if it's $600 a month and you have a mortgage on top of that, it's just really hard to do.”

https://finance.yahoo.com/video/helene-north-carolina-most-theyre-082604363.html

'Walz promises Muslims an equal role in Harris administration'

 Tim Walz, Democratic presidential candidate Kamala Harris's running mate, on Thursday promised Muslim Americans an equal role in their administration should they win the election, as Democrats scramble to win back Muslim backing that has eroded over U.S. support for Israel.

Vice President Harris and Walz, the governor of Minnesota, are trying to woo Muslim voters furious over President Joe Biden's administration's staunch backing of Israel during its year-old war in Gaza against Hamas.

Harris has pledged continued support for Israel while emphasizing her push for a ceasefire, words Walz echoed on Thursday, while promising a role for Muslims.

"Vice President Harris and I are committed that this White House... will continue to condemn in all forms anti-Islam, anti-Arab sentiments being led by Donald Trump, but more importantly, a commitment that Muslims will be engaged in this administration and serve side by side," Walz said during an online meeting organized by Emgage Action, a Muslim American advocacy group that recently endorsed Harris.

The Nov. 5 election between Harris and Republican Trump is expected to be tight, especially in battleground states like Michigan, home to a large Muslim American population. The U.S. continues to back Israel as it targets Hezbollah in Lebanon.

Though Emgage has endorsed Harris, other Muslim groups have urged supporters not to back her in the election, especially after Democrats rejected requests for a Palestinian speaker at the party convention in August.

Harris has offered no substantive policy differences on Israel from Biden, who stepped aside as presidential candidate in July.

Trump has said he would reinstate a "travel ban" he imposed as president restricting the entry into the United States of people from a list of largely Muslim-dominant countries. Biden rolled back the ban shortly after taking office in 2021.

"The scale of death and destruction in Gaza is staggering and devastating," Walz said. Harris is working to ensure "the suffering in Gaza ends now, and the Palestinian people realize the right to dignity, freedom and self determination."

The Israeli military offensive in Gaza has killed more than 41,000 Palestinians, Palestinian health authorities say. Israel was responding to an incursion by Hamas gunmen on Oct. 7, 2023, which Israel says killed around 1,200 people and abducted about 250 hostages.

Gaza has suffered a humanitarian crisis with nearly all its 2 million people displaced and widespread hunger in the enclave.

Other speakers at the event included Democratic U.S. Senator Chris Van Hollen from Maryland and Minnesota Attorney General Keith Ellison, who both suggested that Harris could represent a shift from Biden's approach in the Middle East.

"I know she is a listener. She is able to change her mind," Ellison said, adding Harris was not born in the 1940s, as Biden and Trump were.

"I'm not promising you a rose garden" if Harris is elected, Ellison said. "But we'll be pushing on a door that's not locked."

It was unclear whether Walz, the first speaker, remained on the Zoom call to listen to other remarks. He took no questions.

While other Muslim groups have not supported Republican candidate Donald Trump, some are backing Green Party candidate Jill Stein.

https://www.yahoo.com/news/walz-promises-muslims-equal-role-003453079.html

Kushner has discussed U.S.-Saudi diplomacy with Saudi crown prince

 Jared Kushner, son-in-law of former U.S. President Donald Trump, has discussed U.S.-Saudi diplomatic negotiations involving Israel with Saudi Arabia’s Crown Prince Mohammed bin Salman multiple times since leaving the Trump White House, said a source familiar with the discussions.

The source did not identify when the talks took place and whether they occurred before or after the start of the Gaza conflict. But they included discussions on the process of normalizing relations between Israel and Saudi Arabia, a key diplomatic objective of both the Biden and Trump administrations, the source said.

Kushner, 43, has a close relationship with Saudi Arabia, which congressional investigators say has invested $2 billion in his private equity fund, Affinity Partners, which Kushner set up after leaving the White House.

The news that Kushner and Saudi Arabia’s de-facto leader discussed a peace accord that U.S. President Joe Biden also has tried to broker illustrates the importance both Republicans and Democrats place on the increasingly unstable Middle East amid a razor-close presidential election. The talks also signal how Trump might manage the crisis in the region if voters return him to power – and renew questions about whether Kushner’s financial ties with Riyadh could influence U.S. policy under his father-in-law.

Saudi Arabia’s investments in Kushner’s fund have been criticized by ethics experts, Democrats in Congress and even some Republicans, who have expressed concern that Saudi Arabia’s stake can look like a payoff since Kushner worked on Saudi issues before leaving Trump’s White House.

In a Sept. 24 letter to Affinity, Democratic Senator Ron Wyden, chair of the Senate Finance Committee, wrote that investments by Saudi Arabia in Kushner’s fund raise “obvious conflicts of interest concerns.”

Affinity and Kushner have denied that Saudi Arabia’s investments are a payoff or a conflict of interest. Affinity said Wyden and his Senate staff do not understand the realities of private equity. “The reason so many people go to Jared for his insights and his opinions is that he’s had such a record of successes,” said a spokesperson for Kushner.

The source close to Kushner declined to provide more details of the discussions with the crown prince, also known as “MbS, saying he did not want to violate the friendship between the two. “It wouldn’t be appropriate for me to share that,” the source said.

A spokesperson for the Saudi Embassy in Washington did not answer questions about Kushner’s discussions with MbS.

In a Sept. 18 speech, MbS said the kingdom would not recognize Israel without the creation a Palestinian state, suggesting a deal may be near impossible for the foreseeable future. That’s a shift from February when three sources told Reuters that Saudi Arabia was willing to accept a political commitment from Israel to create a Palestinian state, rather than anything more binding, in a bid to get a defense pact with Washington approved before the U.S. presidential election.

To encourage Saudi Arabia to recognize Israel, the Biden administration has offered Riyadh security guarantees, assistance with a civilian nuclear program and a renewed push for a Palestinian state. The deal could reshape the Middle East by uniting two long-time foes and binding the world's biggest oil exporter to Washington at a time when China is making inroads in the region.

But the Gaza conflict has thrown the talks into uncertainty. The war and humanitarian crisis have strengthened Arab and Muslim support for the Palestinians in their decades-long conflict with Israel over land and statehood, making it difficult for Riyadh to discuss recognizing Israel without addressing Palestinian aspirations.

The U.S. election is also a factor as Trump, a Republican, vies with Vice President Kamala Harris, a Democrat, in a historically tight race for the White House.

The Saudi relationship with Trump was notably close. Trump’s first foreign trip as president in 2017 was to Riyadh, accompanied by Kushner. After Saudi expatriate opposition journalist Jamal Khashoggi was murdered at the Saudi consulate in Istanbul, Trump stood by the crown prince in spite of a U.S. intelligence assessment that he had authorized the killing. MbS denied involvement.

Two sources familiar with Saudi strategy said that if Trump returns to the White House, the crown prince would welcome making a deal with Israel under his leadership. If Harris were to win, the agreement would still move forward, the sources said. Either way, the sources see it as a win-win for MbS, even if it requires a few more months of patience.

On Sept. 27, Israeli Prime Benjamin Netanyahu referred to the prospect of an agreement in positive terms. “What blessing such a peace with Saudi Arabia would bring,” he said in a speech to the UN General Assembly.

Normalizing Israeli-Saudi relations would mark an expansion of the “Abraham Accords” sealed when Trump was in office. The accords led to the normalization of relations between Israel and the United Arab Emirates, Bahrain, Morocco and Sudan. Kushner, who is close to Israel, led the negotiations as a senior adviser in Trump’s White House.

Three sources close to Kushner said that if Trump wins November’s presidential election, they expect Kushner to be involved in the Saudi talks, albeit in an unofficial capacity. A spokesperson for Kushner denied that he is seeking such a role.

If Kushner were to be involved in diplomatic talks as a private citizen in a second Trump term, it could pose a significant conflict of interest, ethics experts say, putting Kushner in the extraordinary position of conducting government-level negotiations with one of his major financial investors.

While Kushner and his wife, Ivanka Trump, have largely stayed away from Trump's campaign events, they were present at the Republican National Convention in July, sitting and clapping in the family box behind Trump.

https://www.yahoo.com/news/exclusive-kushner-discussed-u-saudi-101629564.html

Summit fast tracked on lung cancer therapy

 The US Food and Drug Administration (FDA) has granted fast track designation to ivonescimab for use in combination with platinum-based chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with an EGFR mutation, who have experienced disease progression following EGFR-TKI therapy.

https://finance.yahoo.com/news/summit-completes-subject-enrolment-phase-083234712.html

Exact Sciences: FDA OKs Next-Gen Non-Invasive Colorectal Cancer Screening

 Cologuard Plus™ test raises the performance bar with sensitivities of 95% for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity

Cologuard Plus test will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test

Company expects to launch Cologuard Plus test with Medicare coverage and guideline inclusion in 2025

https://www.businesswire.com/news/home/20241004761985/en

Sweden Could Soon Have 1 Million Illiterates, Largely Due To Mass Immigration

 Via Remix News,

The number of people who are illiterate in Sweden is expected to exceed 800,000 in winter of this year, with researchers expecting the number to soon reach 1 million, in large part due to mass immigration.

The most recent survey by Statistics Sweden shows there are currently around 780,000 people between the ages of 16 and 65 who are illiterate in Sweden, but this number is soaring.

“Each month, eight to ten illiterate students arrive,” said Rita Sommarkrans, SFI teacher in Västerås, to SVT. She added that if someone can’t read or write, it’s hard for them to find a place, pay their bills, or even book a doctor’s appointment. 

“If this trend continues, we risk having an entire generation of young people who are effectively functionally illiterate,” wrote Minister of Education Johan Pehrson and Minister of School Affairs Lotta Edholm in an introductory article.

However, Swedish publication Fria Tider notes that the ministers are failing to explain what the main cause behind the massive illiteracy problem is in the country, which is mass immigration of illiterate adults from the Third World, which the allegedly conservative ruling government is failing to stop.

However, many of these foreigners are bringing children or giving birth to children who are entering the Swedish school system. In some cities, Swedish children are already the minority in the school system, such as Mälmo. In fact, the situation has gotten so extreme in that city that city officials are proposing to teach in Arabic instead of Swedish, as Remix News reported in the past. However, such a move will only accelerate the problem of illiteracy and result in even deeper divisions in society.

Due to the falling literacy rates, Sweden is transforming its entire school system, making compulsory schooling 10 years instead of nine. In 2024, the number of students who were able to successfully complete the compulsory nine-year primary school continued to decrease.

Out of the slightly more than 120,000 Swedish students in primary school, 20,000 finished compulsory school in 2024 without graduating to upper secondary school. This segment of students will have little chance of getting a job or career, and as Swedish news portal Samnytt writes, many of them will turn to crime or welfare to get by.

“It is worrying that the results of 9th graders are decreasing. More students should complete primary school, not fewer. Failure to complete primary school is one of the main risk factors for unemployment and social exclusion,” said Anna Castberg, a department head at the Swedish Education Agency, in an official press release.

The Swedish National Education Office notes that the education level of the parents greatly influences the grades of the children. The lowest level of education is found among non-Western migrants, and consequently students of this group dominate among the worst performers. In addition, the education gap between Swedes and migrants is increasing instead of decreasing. 

Most new citizens come from non-EU Muslim countries

In fact, a new report from the Swedish Migration Agency now shows that Sweden has granted 660,362 migrants Swedish citizenship since 2015, with the vast majority coming from non-EU Muslim countries.

One of the top recipients of Swedish citizenship is Somalia, which is a country with one of the lowest levels of education in the world and an official illiteracy rate of 62.2 percent. In many cases, the people arriving from this country do not even know how to read and write in their own language, let alone Swedish. Data shows that 53,543 Somalians received citizenship since 2015, the second most of any country.

In first place was Syria, with 147,579 Syrians receiving citizenship since 2015, or 22 percent of the total.

Sweden’s performance in the PISA test has also drastically fallen, which will have dramatic results for Sweden’s economy over the coming years, as the country relies on a highly trained and high-tech workforce delivering high-value goods to the world market. In fact, the government was embroiled in a scandal in 2020 when its high PISA scores turned out to be a fraud.

At the time, Sweden’s Expressen wrote, “The latest PISA results showed an increase for Swedish students. Expressen can now reveal how a large number of foreign-born students were wrongly removed from the PISA selection, and that Sweden thereby violated the OECD’s official regulations. The figures also suggest that Swedish-born students with weak language skills were also removed.”

The paper further wrote that “If the rules had been followed, the Swedish results would have been significantly worse and Sweden would probably have gone backwards in all three subjects compared to the last exam.”

Swedish schools are now dangerous for teachers and students

Swedish schools are also becoming more dangerous. The Swedish Teachers’ Union (Sveriges Lärare) issued a warning about the increased threats and violence facing teachers in Stockholm.

The number of serious incidents increased 36 percent to 159 cases in 2023 compared to 2022.

“There are threats ranging from ‘I’ll kill you’ and ‘I’ll shoot you’ to direct acts of violence,” said Simon Sandström, the union’s security officer, in an interview with Swedish Radio.

https://www.zerohedge.com/political/sweden-could-soon-have-1-million-illiterates-largely-due-mass-immigration