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Wednesday, February 5, 2025

Amazon set to release long-delayed Alexa generative AI revamp

 Amazon is set to release its long-awaited - and delayed - Alexa generative artificial intelligence voice service, said three people familiar with the matter, and has scheduled a press event for later this month to preview it.

Once released, it would mark the most significant upgrade to the product since its initial introduction accelerated a wave of digital assistants more than a decade ago.


Amazon on Wednesday sent press invites to an event to be held on Feb. 26 in New York featuring the head of its devices and services team, Panos Panay. A spokesperson said the event is Alexa-focused, while declining to elaborate.

The new generative AI-powered Alexa represents at once a huge opportunity for Amazon, which counts more than half a billion Alexa-enabled devices in the market, and a tremendous risk. Amazon is hoping the revamp, designed to be able to converse with users, can convert some of its hundreds of millions of users into paying customers in an effort to generate a return for the unprofitable business.

The AI service will be able to respond to multiple prompts in sequence and, company executives have said, even act as an “agent” on behalf of users by taking actions for them without their direct involvement. That contrasts with the current iteration, which generally handles only a single request at a time.

Executives have scheduled a meeting, known as a "Go/No-go," for Feb. 14. There they will make a final decision on the "street readiness" of Alexa's generative AI revamp, according to the people and an internal planning document seen by Reuters.

Alexa's revamp carries with it all the challenges inherent in now-familiar generative AI chatbots from OpenAI, Alphabet and others including the possibility of fabricated answers, known as hallucinations. With access to Alexa available in cars, televisions, thermostats and mobile phones, it could become an essential daily tool for scheduling and even shopping.

Initially, Amazon plans to roll out the new Alexa service to a limited number of users and will not charge for it, the people said, though it has considered a $5 to $10 monthly fee. The company will also continue to offer what it is calling “Classic Alexa,” the version broadly available today for free. One of the people said Amazon has discontinued adding new offerings to Classic Alexa.


https://ca.finance.yahoo.com/news/exclusive-amazon-set-release-long-184225757.html

FDA Warns on Safety Alert Settings When Using Smartphone-Compatible Diabetes Devices

 The U.S. Food and Drug Administration is alerting patients of a safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems, that rely on a smartphone to deliver critical safety alerts. Users of these smartphone-compatible diabetes devices can configure alert settings, such as which alerts to receive, how often and how the alerts are delivered (e.g. audible, vibration, text only) through the app on their phone.

The FDA has received medical device reports in which users report these alerts are not being delivered or not being heard, in cases where the users thought they had configured the alerts to be delivered. In some cases, missing these alerts may have contributed to serious harm, including severe hypoglycemia (low blood sugar), severe hyperglycemia (high blood sugar), diabetic ketoacidosis (when the body does not have enough insulin to use blood sugar for energy) and death.

"Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them. However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected," said Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA's Center for Devices and Radiological Health. "Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected."

The FDA has identified, among others, the following hardware and software changes, updates and configurations that may lead to critical alerts not being received as expected:

  • software configuration issues, such as app notification permissions, using "do not disturb" or "focus mode" or the app entering "deep sleep" after a period of not being used;
  • connecting new hardware to the smartphone, such as connecting to car audio or using wireless earphones, that can change the default volume of alerts or prevent delivery of alerts; and
  • smartphone operating system updates that are not supported by the medical device application.

The FDA's safety communication provides recommendations, such as the following, for users of these devices:

  • Carefully follow the instructions provided by diabetes device manufacturers when installing, setting up or updating mobile medical apps on the smartphone;
  • turn off automatic operating system (OS) updates to the smartphone and do not update the phone's OS until confirming the diabetes device app is compatible with the new OS version;
  • after updating the phone's OS or adding a new accessory, such as wireless headphones, confirm alert settings then carefully monitor the medical device app to make sure alerts are received and can be heard as expected;
  • at least once a month, check that the smartphone alerts are configured as expected;
  • if alerts are not being received as expected from the mobile medical app, or cannot be heard, call the technical support number for the medical device for assistance; and
  • report any problems with the diabetes device to the FDA.

'US Diplomats Warn Trump That Sending Gazans To Egypt Will Destabilize Sisi Regime'

 Via Middle East Eye

Egypt will not be swayed to take in Palestinians from the Gaza Strip, US officials in the region have told the White House in recent days as they brace for the Trump administration to ramp up pressure on Cairo, Middle East Eye can reveal.

Trump has also said that Jordan will take in Palestinians ahead of King Abdullah II’s visit to Washington next week. The growing divide between diplomats and the White House has heightened tensions, pitting President Donald Trump and his closest advisers against career diplomats in the region, who are ferrying messages to Arab officials.

Displaced Gazans, via Crisis Group

In the case of Egypt, US officials warned the White House that the controversial proposal could destabilize a close ally and that Egypt would not be susceptible to financial incentivesa senior US diplomat in the region told MEE.

The notion that Palestinians can be moved to Egypt, Jordan or any third country is widely regarded as ethnic cleansing of the besieged enclave and would likely violate international law.

Another mid-level US diplomat in the region working on this issue told MEE that the White House appeared “tone deaf” to the assessments of US diplomats and remained intent on pursuing the plan to send Palestinians to Egypt.

Last week, US Secretary of State Marco Rubio raised the topic in a phone call with his Egyptian counterpart, Badr Abdelatty, one of the officials told MEE. Both US officials say they expect the rift between US embassies in the region and the White House to widen following Israeli Prime Minister Benjamin Netanyahu’s meeting with Trump on Tuesday.

'Pure demolition site'

Ahead of his meeting with Netanyahu at the White House, Trump reiterated his stance on Gaza, calling it a “demolition site” and saying that the best solution would be to “just clean out that whole thing”.

"It's a pure demolition site. If we could find the right piece of land, or numerous pieces of land, and build them some really nice places with plenty of money in the area, that's for sure. I think that would be a lot better than going back to Gaza," he told reporters.

Steve Witkoff, Trump’s Middle East envoy, said on Tuesday that “solving where people will go” had become a “big issue”. Trump had initially said Egypt could take in refugees temporarily, but Witkoff indicated otherwise. "It is unfair to have explained to Palestinians that they might be back in five years. That's just preposterous,” he said.

Both Trump and members of his administration said on Tuesday that it would take 10 to 15 years to rebuild Gaza, with Trump saying that it is "inhumane" to make people live in a place that's "uninhabitable".

Israel has made no secret of its desire for Egypt to accept Palestinian refugees from Gaza following its offensive on the enclave in response to the Hamas-led 7 October attacks. Egyptian officials at the time said accepting forcibly displaced Palestinians was a “red line”, and the discussion faded.

However, the ceasefire has shifted Israel’s priorities and the Trump administration’s public backing of the idea has emboldened Israel’s leadership. Trump’s son-in-law and former adviser, Jared Kushner, first proposed the forced displacement of Palestinians from Gaza in March 2024.

Egyptian officials remain publicly resolute in their refusal to accept Palestinians. President Abdel Fattah el-Sisi said last week that it was “an injustice that we cannot take part in”.

Egypt braced for cut in military aid

An Egyptian diplomat told MEE that Cairo is taking Trump’s rhetoric seriously and is preparing for the possibility that the $1.3bn in annual US security assistance could be suspended if the Trump administration attempts to use it as leverage.

Trump has generally maintained good relations with Sisi, whom he famously referred to as his “favorite dictator” in 2019.

According to the diplomat, Sisi has actually benefited from Trump’s rhetoric, as it has allowed him to embrace the popular Palestinian cause at a time when Egypt is struggling with debilitating economic crises.

The country has been grappling with currency devaluation and inflation. Last year, it secured a $7.6bn aid package from the European Union, split between grants and favorable loans.

Egyptian security services organized rare protests at the Rafah border crossing with Gaza on Friday in a show of defiance against Trump’s plea. The protests came two days after the US ambassador to Egypt, Herro Mustafa Garg, a career diplomat, visited the crossing.

Egypt has already taken in about 200,000 Palestinians from Gaza since the start of Israel's war on Gaza, the source said. A neighborhood referred to as "Little Gaza" has sprung up in Cairo.

The Palestinian ambassador in Cairo put the official number lower, saying between 80,000 and 100,000 Palestinians had entered Egypt. The Egyptian diplomat also told MEE that Cairo is considering organizing protests in front of the US embassy as well.

Sisi rules Egypt with an iron fist and popular protests are not tolerated. Sisi came to power in a 2013 coup that toppled Egypt’s first democratically elected president, Mohamed Morsi.

"If I were to ask this of the Egyptian people, all of them would take to the streets to say ‘no’," Sisi said last week. One Egyptian official with knowledge of the matter told MEE that while Sisi and his closest advisors have privately entertained the idea of accepting more Palestinians from Gaza, Egypt's military establishment is adamantly opposed to any discussion

https://www.zerohedge.com/geopolitical/us-diplomats-warn-trump-sending-gazans-egypt-will-destabilize-sisi-regime

RFK Jr odds on for HHS role after Finance Committee vote

 Robert F Kennedy Jr has cleared a key obstacle in his bid to become the next US Health and Human Services (HHS) Secretary after the Senate Finance Committee voted in his favour.

The Committee voted by 14 to 13 in favour of President Trump's controversial pick, split down party lines, with Republicans praising his determination to reform the US healthcare system while Democrats voiced concern about his track record on health, and particularly his prominent anti-vaccine stance in the recent past.

The vote was, however, tipped in favour of Kennedy by Republican Senator Bill Cassidy, a qualified gastroenterologist who said in the build-up that he had reservations about his ability to lead the agency, which administers a $1.7 trillion budget and plays a huge role in public health through its oversight of the FDA, Centers for Disease Control and Prevention (CDC), National Institutes of Health, and the Centers for Medicare & Medicaid Services (CMS).

Cassidy said after the vote that he had received assurances from Kennedy that he would not undermine immunisation programmes – for example, by removing statements on the CDC website that vaccines do not cause autism – and that they would work closely together if he is confirmed.

"With the serious commitments I've received from the administration and the opportunity to make progress on the issues we agree on, like healthy foods and a pro-American agenda, I will vote yes," he wrote on social media platform X.

The vote means that Kennedy's nomination now moves forward to the Senate floor for a vote. If the lawmakers vote according to their political allegiances that should take him through. He would be blocked if all Democrats and three Republicans vote against him, but that it now viewed as unlikely.

There's no doubt that Kennedy's political career has been marked by controversy, with outspoken views on various topics, including vaccine safety, which have often placed him at odds with mainstream political and scientific thinking.

At the same time, he has been a vocal proponent of healthcare reform under the Make American Healthy Again (MAHA) banner; for example, by limiting processed foods. He has also advocated for measures to ensure affordable and accessible healthcare for Americans and insisted that his views on vaccines are driven by concern about safety, rejecting claims he is a conspiracy theorist.

Meanwhile, Kennedy has been in favour of measures to slash prescription drug prices and implementing preventive care programmes to address public health challenges. Senate Finance Committee Chair Mike Crapo asserted ahead of the vote that he had "spent his career fighting to end America's chronic illness epidemic and has been a leading advocate for healthcare transparency both for patients and for taxpayers."

Senior Democrat Senator Elizabeth Warren took Kennedy to task during confirmation hearings last week, alluding to claims that he made $2.5 million in referral fees from a legal firm bringing lawsuits against pharma companies and that he gets a 10% contingency fee if they win.

That applies to an ongoing legal complaint against MSD over its Gardasil cervical cancer shot, for which Kennedy has already received referral fees.

Warren asked him to pledge not to receive any compensation from lawsuits against pharma companies as HHS secretary and four years after his term, which he declined to do. That led her to suggest he could profit from anti-vaccine lawsuits that he could influence as HHS Secretary.

After the hearing. Kennedy said he would divert any fees from the Gardasil litigation to his adult son, but Warren maintained that is an inadequate measure to offset the potential conflict of interest.

https://pharmaphorum.com/news/rfk-jr-odds-hhs-role-after-finance-committee-vote

'Lara Trump takes swanky job as host of brand new Fox News show'

 Lara Trump's next move is to join Fox News, DailyMail.com can confirm.

President Donald Trump's daughter-in-law is even starring in her own weekend show. The network will announce Mrs. Trump is joining their roster later on Wednesday.

Lara was co-chair of the Republican National Committee (RNC) last year and helped deliver widespread wins for the GOP in the 2024 election.

After her husband Eric's father won reelection in November, Lara stepped down from her post at the RNC. Soon after, she shut down rumors that she would seek to replace Sen. Marco Rubio and become a U.S. Senator in Florida.

Instead, she is taking a cushy spot with the right-leaning network.

President Trump was able to persuade some other Fox personalities – mainly Pete Hegseth and Sean Duffy – to join his administration. The former took a role as the Pentagon Secretary and latter is leading Trump's Department of Transportation.  

Lara's new show will help re-round out the network's team of high profile conservative hosts.

Her weekend slot will begin airing on Fox News on February 22.

https://www.dailymail.co.uk/news/article-14364721/Lara-Trump-job-host-Fox-News-show.html

GeneDx targeted in short report by Grizzly Research

 Grizzly Research has shorted GeneDx, a genetic testing company, accusing them of widespread fraud. GeneDx specializes in advanced genomic testing, with a focus on rare and ultra-rare genetic disorders. The company's stock has seen a substantial rise of over 2,500% since the beginning of 2024, making it one of the most prominent performers of the year. This increase is attributed to the company's reported success in substantially raising revenue while controlling its cash burn.

Grizzly Research, however, alleges that the company's growth is largely a result of fraudulent schemes and illegal tactics designed to exploit Medicaid and Medicare systems to artificially boost revenue. The firm cites testimonies from former employees and ongoing litigation as evidence that GeneDx has increased its revenue through an unlawful practice known as "code stacking." This practice, which has been prohibited since 2013, allows the company to bill insurance providers for services that do not meet the required criteria.

The company was sold by OPKO Health, owned by well-known microcap fraudster Phillip Frost, to Sema4 for around $330 million. Following the acquisition, Sema4's operations were almost entirely shut down. GeneDx, which was previously known as Sema4, is now valued at $2 billion on the stock exchange, almost seven times its selling price, just 1.5 years after the sale.

CEO Katherine Stueland and CFO Kevin Feeley have been consistently selling their shares immediately upon vesting, without ever buying in the open market. This behavior suggests that company insiders may be aware of a significant risk that could greatly affect the company.

In 2022, before changing its name from Sema4 to GeneDx, the company had a dispute with UnitedHealthcare, which resulted in a settlement to repay $42 million over four years. Grizzly Research's investigation suggests that the dispute was due to fraudulent code stacking, a fact that was not disclosed to investors.

Former employees have claimed that the company has continued the illegal code stacking practice, which is estimated to inflate revenue by approximately 25%. A former Vice President of the company stated that the scale of the code stacking scheme necessitates the active involvement of key executives, including CEO Katherine Stueland, CFO Kevin Feeley, and Chief Technology & Product Officer Matt Davis.

Grizzly Research anticipates that Medicare, Medicaid, and other health insurers will seek to recover overpayments made to GeneDx due to the illegal code stacking practices. The firm's research also revealed an undisclosed whistleblower action against GeneDx. Whistleblowers have claimed that the company is operating illegal "independent" counselor entities that direct patients exclusively to GeneDx testing services.

Industry sources suggest that the Department of Justice is increasing efforts to combat Medicare and Medicaid fraud, particularly focusing on billing practices. Over $800 million in fines have already been issued against perpetrators, and Grizzly Research believes that GeneDx could be next in line for a substantial fine.

Since the name change from Sema4 to GeneDx, former employees testify that the company's relationship with Mount Sinai, a renowned school and hospital network, has deteriorated. Former employees also claim that the company's previous healthcare data platform, Centrellis, was merely a facade. GeneDx was using it to present itself as a data company rather than a diagnostics company to gain a higher multiple on the stock market. Achieving the company's objectives for Centrellis would have required billions of dollars and several additional years of effort.

Clinical geneticists and industry experts have raised concerns that GeneDx's tests do not offer superior accuracy compared to competitors, and the company lacks any sustainable competitive advantage in the marketplace.

GeneDx is also facing internal morale issues after Katherine Stueland laid off more than half of the company's staff. Many former employees cite nepotism and favoritism towards ex-Invitae employees.

This article was generated with the support of AI and reviewed by an editor. 

https://www.investing.com/news/stock-market-news/genedx-targeted-in-short-report-by-grizzly-research-93CH-3851035

EyePoint Positive 6-Month Results for Phase 2 Trial for Diabetic Macular Edema

 

Meeting Primary and Secondary Endpoints

 Primary endpoint achieved by both DURAVYU doses (1.34mg and 2.7mg) with extended time to first supplemental injection versus aflibercept control –

- DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a 24-week gain of +7.1 letters and anatomical improvement of 76 microns reduction in CST paired with reduction in treatment burden of two-thirds

– Favorable safety profile continues with no DURAVYU-related ocular or systemic SAEs –

– Phase 3 non-inferiority pivotal program initiation anticipated by the end of 2025 –

https://www.globenewswire.com/news-release/2025/02/05/3021051/0/en/EyePoint-Announces-Positive-Six-Month-Results-for-the-Phase-2-VERONA-Clinical-Trial-of-DURAVYU-for-Diabetic-Macular-Edema-Meeting-Primary-and-Secondary-Endpoints.html