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Monday, May 11, 2026

Boston Scientific recalls pacemakers after 4 deaths, 2,500 injuries

 Boston Scientific issued a recall involving a correction on all 27 Accolade pacemakers and CRT-Ps, according to a May 7 FDA news release. The agency identified the recall as Class I.

Here is what to know.

1. A battery issue can cause the devices to permanently enter safety mode, which limits functionality and may leave the pacemaker unable to properly regulate heart rhythm. 

2. The FDA reported 2,557 serious injuries and four deaths related to this issue.

3. The recall involves correcting devices — not removing them from where they are used or sold. The FDA warns that the device may cause serious injury or death if it continues to be used without correction.

4. Boston Scientific is recommending all affected devices be upgraded to Brady SMR6 software and that physicians update the medical record for each patient with an affected device to ensure continuous awareness throughout the device’s remaining life.

5. In February 2025, the company recalled its Accolade pacemaker devices due to a manufacturing issue that could cause the devices to enter safety mode, requiring replacement. In December 2024, the FDA issued a safety alert for some Boston Scientific Accolade pacemakers after reports of a battery-related manufacturing issue causing the devices to initiate safety mode.  

https://www.beckershospitalreview.com/quality/patient-safety-outcomes/boston-scientific-recalls-pacemakers-after-4-deaths-2500-injuries/

Protein Supplement Tied to Better Outcomes for Patients on Dialysis

 Intradialytic oral protein supplementation was linked with improvements in several nutritional markers and real-world outcomes for patients on hemodialysis, according to a quality improvement study.

After 12 months, patients who received a liquid protein supplement at the end of each dialysis session had significant improvements in real-world outcomes. The frequency of hospitalizations dropped from 4.02 to 2.60 times per month and the average duration of hospital stays decreased from 5.71 to 4 days per month, reported Firouzeh Jazayeri, MSPH, RD, of UF Health in Gainesville, Florida.

This highlights the importance of integrating nutrition-focused interventions into routine dialysis care to improve overall patient outcomes, Jazayeri said at the National Kidney Foundation Spring Clinical Meeting.

Patients also demonstrated improved hemodialysis adequacy, with Kt/V rising from 1.56 to 1.69. This measurement indicates how effectively dialysis removes uremic toxins and the rise suggests improved treatment efficiency.

The normalized protein catabolic rate (nPCR) -- a measure of protein breakdown in the body -- also increased and remained above 1 g/kg/day. There was a significant positive correlation between nPCR and Kt/V (r=0.63, P=0.02), suggesting that higher protein intake is associated with better solute clearance and treatment efficiency.

"This initiative demonstrates that nutrition and dialysis adequacy are not separate targets, but closely interconnected," she noted. "Our findings suggest that intradialytic protein supplementation can improve nutritional status without compromising dialysis adequacy, and may even support better clearance outcomes."

Throughout the intervention, patients also had significant improvements in serum albumin (3.59 g/dL at baseline to 3.78 g/dL at month 12, P=0.02), with the largest gains occurring in the first 6 months. Albumin is the most abundant protein in the body and serves as a primary marker of protein energy wasting, she explained.

Serum creatinine -- an indirect marker of muscle mass -- also increased modestly from 8.46 mg/dL to 9.29 mg/dL. While this suggests a stabilization of muscle mass, the change did not reach statistical significance.

Low albumin is one of the strongest predictors of poor dialysis outcomes. Jazayeri explained that when protein energy wasting is present, it can negatively affect a patient's tolerance to treatment.

"As we all know, protein energy wasting is common and frequently under-recognized in this population," she said. It "starts at the very early stage of the renal failure and continues to progress as the kidney function declines. Protein energy wasting contributes to muscle loss, fatigue, reduced functional status, and poor recovery from illness."

Prior data have also tied a serum albumin level under 3.0 g/dL to an increased risk of mortality, including all-cause, cardiovascular, and infection-related mortality in dialysis patients.

While current guidance suggests that chronic kidney disease patients limit protein to a target intake of 0.6 to 0.8 g/kg of body weight so kidneys don't have to work overtime to remove excess waste, this recommendation is reversed once patients progress to dialysis. At that stage, a higher protein intake of 1 to 1.2 g/kg of body weight is necessary to maintain blood protein levels.

Because many patients struggle to meet this requirement through food alone, intradialytic supplementation provides a practical solution, said Jazayeri. By providing protein during the catabolic period, the intervention improves adherence and specifically targets high-risk patients.

The study followed 24 hemodialysis patients who had serum albumin levels below 4.0 g/dL for at least 3 months. Participants were given a 1-oz. liquid protein supplement containing 15 g of protein at the end of each session for 12 months.

Jazayeri concluded by noting the intervention was "very cheap" to implement.

Disclosures

What's Next for Hantavirus Cruise Passengers

 Passengers aboard the MV Hondius, the ship afflicted by a hantavirus outbreak, remain at sea, with plans to dock in the Canary Islands on Sunday.

James Lawler, MD, MPH, of the University of Nebraska Medical Center's Global Center for Health Security in Omaha, is an expert on outbreak response and led teams aboard the Diamond Princess cruise ship when it had an outbreak of COVID in the earliest days of the pandemic.

MedPage Today asked Lawler about what's expected to happen when the MV Hondius can finally dock, about how Americans who disembarked the ship weeks ago and returned to the U.S. are being monitored, and potential risks to healthcare workers. He also discusses a project that can help hospitals improve their infection prevention and control strategies.

An edited transcript of the conversation follows.

Why does it usually take so long for ships to dock when there's an infectious disease on board?

Lawler: Unfortunately it's a common occurrence when we have outbreaks of high-consequence infectious diseases. There's obviously a huge fear factor among the general population and then politicians and policymakers often respond to those pressures and ... many times end up making what are maybe not the best decisions, certainly in the interest of controlling the outbreak or in caring for the people who are affected.

That often works against the public health workers and healthcare workers trying to manage cases, trying to contain the outbreak. Delaying the ship's docking until Sunday not only means we won't be able to take people off of the ship until then if something happens, but it also means that responders and epidemiologists won't have access to the ship, which is going to be an important part of doing a full investigation.

Passengers who are currently symptomatic were evacuated, but if more people develop symptoms -- and this is a disease where you can decompensate pretty quickly -- not being able to get them critical care until Sunday seems like a big deal.

Lawler: It does. It is a little bit more of a difficult disease to manage in that sense because the incubation period is so long, 6 or 7 weeks in some cases, and because people do tend to decompensate quickly once they start going down that path.

Usually there are several days of prodromal illness where you don't have a lot of lung or respiratory involvement. But when the phase of disease hits where you start to get dysfunction of the cardiopulmonary system and people start experiencing shortness of breath or cough, in many cases those folks can decompensate within 24 hours, and that means that they may go from being OK, sitting around on room air, to being on a ventilator with a breathing tube down their throat.

You were aboard the Diamond Princess cruise ship in Japan during COVID. Can you talk a little bit about what the expected response would look like in this case?

Lawler: I think it's probably true that if you've seen one shipboard outbreak response, you've seen one shipboard outbreak response, and they're all going to be different depending on the ship, the circumstances, and the pathogen.

Things on the Diamond Princess were a bit unusual because it was very early in COVID. We really didn't understand a whole lot about that virus: how it was transmitted, how severe the disease was, what the most important environmental and human contact risk factors were. And there were a lot of different interpretations of what appropriate infection prevention control measures should be.

It was a large outbreak that involved Japanese and American assets. This will be quite a bit smaller. It's a much smaller ship, a much smaller group of passengers and crew. I think that the response teams will be smaller and probably a bit more organized, although it's still going to be somewhat make-it-up-as-you-go.

It helps a lot understanding what virus you're dealing with and what the predominant modes of transmission and risk are. So that makes it a bit easier, I think, for folks to essentially adopt the appropriate infection prevention control posture. Although I will add that there are still a lot of open questions we have about Andes virus in particular.

We've learned a lot over the last 6 years, particularly from COVID, but that also prompted us to reevaluate a lot of data on additional diseases that make us realize that maybe the very rigid approach we had to bucketing different types of infection risk probably didn't really reflect how things occur in nature and we need to think about more of a continuum.

What will the procedures for bringing these people home look like?

Lawler: There will probably be multiple countries [involved]. ... There will be an in-depth assessment of [individuals'] potential risk: Did they have contact with known cases? Did they have contact with people who were symptomatic?

Everybody's been on this ship together for weeks now, sharing meals, and it's not a large ship. There's pretty significant mixing of all of these people together. So it's going to be really hard in some instances to differentiate risk. I think it's almost impossible in this situation to say that somebody is at zero risk.

At the end of the day, I think anybody who was on that ship is probably going to need to be in quarantine, or at least under close observation, for a period of time. Often these decisions will end up being situational and individual.

For some people, it may make the most sense for them to have their quarantine period in an actual dedicated quarantine unit to be able to observe them. For others, they may have home monitoring, as long as they are not in a situation where others might potentially be at risk.

All of that assessment will be done, and then there will probably be some sort of choreographed movement of those persons who are repatriated on some sort of official aircraft. Historically, for the U.S., the State Department has run those operations and uses chartered aircraft with folks that have been trained and worked with their teams in moving high-risk exposed persons or even infected patients. That was done in the 2014 Ebola crisis and in a lot of different circumstances.

Many passengers have returned home already, including several Americans. Is it a concern that they've been back in the community without monitoring?

Lawler: It certainly is a concern and public health officials have been working hard to track down all of these folks to do risk assessments to make sure they're not symptomatic and to then put them in some sort of monitoring status.

Because the incubation period is so long, the period of risk goes out quite a long time, and some of these patients may have been on an aircraft with one of the symptomatic persons at that time.

Your clock starts for your incubation time and observation time at the last point of contact. That would be a point of contact that was not that long ago. They're still well within the incubation period window and will be potentially for another month or more.

I think the [World Health Organization] made it clear that this is not the next COVID pandemic. This is not a virus that has explosive transmission potential and is going to run through a community quickly. But it does present risk potentially to people who've had contact with ill folks. And certainly if people do get sick, it can cause very severe disease, which is difficult to manage, often requiring intensive care and high levels of supportive care to get folks through it if they can survive.

They could still seek care in the community. What are the risks to U.S. healthcare workers?

Lawler: It certainly is a concern if any of these people end up encountering healthcare, and particularly if they're symptomatic.

The risk in the healthcare setting, historically with this virus, has not been as severe as with many other viral diseases we deal with. The hemorrhagic fevers like Ebola, as well as SARS-CoV-2, or even influenza are much more transmissible in the healthcare setting. But there have been cases of transmission to healthcare workers and transmission to other patients in healthcare settings as well [with Andes virus].

If the passengers being monitored seek care per the correct protocols, how would they be treated?

Lawler: We would consider this a high-consequence pathogen. It has significant transmission risk from person-to-person. It has a very high lethality, about 30% for all-comers. We don't have specific medical countermeasures for it. And so all of those things combined put this in a special category along with Ebola, Marburg, and Lassa -- all the ones that we would monitor in a biocontainment unit.

I think in most cases, folks would want to move this case to a biocontainment unit where you have not only dedicated built infrastructure, but more importantly, you have a team that has been training on how to manage these cases, how to implement appropriate infection prevention control practices, how to use personal protective equipment [PPE] appropriately.

If somebody's sick with Andes virus infection, they probably are going to end up in one of the patient biocontainment units across the country. These are the 13 top-tier centers that have been developed since the 2014 Ebola crisis. There's now a second tier that's being reconstituted, so there are more facilities than just those 13 that certainly have the ability to care for them. But those 13 are the top-tier dedicated units that would be used for this.

It's important to recognize -- and obviously we saw this early in COVID -- we have nationally a very limited capacity for providing isolation care, particularly for high-consequence infections that require more aggressive infection prevention control posture precautions against contact droplet and airborne transmission. And so it is very demanding in terms of the resources required from a hospital to support this.

You're involved with a project that aims to improve U.S. capacity for managing high-consequence infectious disease patients. Tell us more about it.

Lawler: Having isolation rooms at hospitals is a big capital investment. Our PPE supply chains are relatively fragile still, and there's a waste management challenge. Finally, most hospitals don't have the resources for a dedicated biocontainment team. All of that means it's really difficult to take care of these patients using our current paradigm. And if it's this challenging in the U.S., you can only imagine how challenging it is in resource-limited settings in low- and middle-income countries.

So we were thinking about creative ways to change the game, so to speak. That's where we came up with the ISTARI project. Our partner, an engineering design firm out of San Francisco, had designed a prototype during the Ebola crisis in response to a DARPA [Defense Advanced Research Projects Agency] challenge.

They took the current paradigm of how healthcare workers put on PPE and we go interact with the patient and then we come back and we take it off. Our approach is, what if you were to put the protection around the patient? And then the healthcare worker could interact with the patient through that barrier, but not have to constantly don and doff.

We ended up developing four different products that fit different use cases, but the device that got pushed to the front was a smaller footprint device that could be used in an emergency department or a small clinic or hospital setting. We eventually took it through FDA clearance, which we got in 2024.

CareCubes started marketing the device just about a year ago to U.S. hospitals. They've had a number of hospitals that have made purchases, and some of the 13 [national biocontainment facilities] are going to be early adopters for this.

It's our hope that we can use those teams to be subject matter experts for some of the smaller hospitals in their regions, because it's not only for the potential Ebola case that comes back from West Africa. Many rural hospitals in the U.S. are seeing TB [tuberculosis] cases, and not uncommonly, drug-resistant TB cases. Unfortunately, they're seeing a lot more measles cases now, which are incredibly infectious and transmitted in healthcare settings. They're seeing flu, which you worry about in areas where there's heavy poultry and livestock production because of the risk of avian influenza. All of those would benefit from early and aggressive isolation care.

The intent of this was to make it easy enough to be integrated into routine care. So somebody comes in with a fever and a cough. Until they get worked up and characterized, you could care for them through one of these devices. And now your healthcare workers are safe. All of the other patients and bystanders around them are safe. It just allows you to deliver much better care in a way that limits opportunities for outbreaks and spread.

https://www.medpagetoday.com/special-reports/features/121181

"Friendly Local Assassin" Suspect In WHCD Pleads Not Guilty

 In a federal courtroom in Washington this morning, 31-year-old Cole Tomas Allen entered a not guilty plea to charges stemming from the April 25 shooting incident at the White House Correspondents’ Association (WHCA) Dinner. The plea sets the stage for a high-profile trial that could determine whether Allen faces life in prison for what authorities describe as an attempted assassination of President Donald Trump.

Allen was tackled by Secret Service after gunfire erupted just outside the ballroom packed with roughly 2,600 attendees - including the President, First Lady Melania Trump, Vice President JD Vance, and numerous Cabinet officials and journalists.

The night of April 25...

Around 8:36 p.m. EDT, as dinner service was underway, Allen - armed with a 12-gauge Maverick shotgun, an Armscor Precision .38 semi-automatic pistol, and multiple knives - rushed past a security checkpoint on an upper level of the hotel. He fired at least one shot (reports indicate possible additional rounds) in the direction of law enforcement before being tackled by Secret Service agents and other officers.

One Secret Service agent was struck in his bulletproof vest by buckshot; he was treated and released from the hospital. Allen sustained a knee injury after tripping during the confrontation but was not shot. No bystanders or attendees were injured or killed. President Trump was quickly surrounded by agents and evacuated - 10 seconds after JD Vance, and the dinner was halted and later rescheduled.

Surveillance footage captured the rapid sequence: Allen sprinting with weapons visible, the sound of gunfire, and swift law enforcement response. Allen had checked into the hotel as a guest days earlier, traveling by Amtrak from his home in Torrance, California.

Born April 11, 1995, Allen is a California native with an extensive academic background - earning a bachelor’s degree in mechanical engineering from the California Institute of Technology (Caltech) in 2017 and a master’s in computer science from California State University, Dominguez Hills in 2025. He interned at NASA, worked part-time as a tutor at C2 Education in Torrance (named “Teacher of the Month” in December 2024), and developed video games, including a 'non-violent fighting game' (lol) called Bohrdom that was later removed from Steam following his arrest.

Acquaintances and family described him as highly intelligent, polite, inquisitive, and generally “gentle” or “super stable,” with no prior criminal history. He lived with his parents and siblings, regularly practiced at shooting ranges, and had expressed anti-Trump political views online and in person—including a small donation to Kamala Harris’s 2024 campaign and attendance at protests.

The Manifesto and Alleged Motive

Approximately 10 minutes before the attack, Allen emailed a lengthy note titled "Apology and Explanation" to family members. In it, he apologized for “abusing” their trust and stated he did not expect forgiveness. He exhibited deep hatred of Trump, referring to himself in one passage as the "Friendly Federal Assassin" and outlining an intent to target “administration officials (not including Mr. Patel)” - widely interpreted as sparing FBI Director Kash Patel - from highest-ranking to lowest.

The document criticized specific actions such as federal operations against alleged drug boats and highlighted what Allen perceived as lax security at the hotel and event. Also for some reason FBI Director Kash Patel was not a target. 

Authorities have described the note and related materials recovered from his devices and hotel room as a manifesto reflecting political grievances and a belief that it was his “duty” to act. Investigators are still examining the full scope of his radicalization, but preliminary findings point to targeted political violence rather than random or personal animus.

Developments

Allen was charged days after the incident with attempting to assassinate the president, assaulting a federal officer with a deadly weapon, and multiple firearms violations (including interstate transportation of a firearm with intent to commit a felony and discharging a firearm during a crime of violence). A federal grand jury later returned a four-count indictment.

He has remained in federal custody in Washington. Early proceedings included concerns over his detention conditions - initially on suicide watch, later removed - prompting a federal magistrate judge to express alarm about his treatment, including reports of five-point restraints, and to demand explanations from jail officials (poor baby!). Allen’s defense team has filed motions, including one seeking the recusal of U.S. Attorney for D.C. Jeanine Pirro, and has highlighted what they describe as unusually harsh conditions compared to other high-profile detainees.

Today’s arraignment before Judge Trevor McFadden was the first formal opportunity for Allen to enter a plea on the indicted charges. With the not guilty plea entered, the case now proceeds toward trial, discovery, and potential pre-trial motions. If convicted on the lead count, Allen could face life imprisonment.

https://www.zerohedge.com/political/friendly-local-assassin-suspect-white-house-correspondents-dinner-shooting-pleads-not

Moderna Extends Rally After Two More Cruise Ship Passengers Test Positive For Hantavirus

 Moderna shares are up another 7% in premarket trading, as renewed alarm over the hantavirus-plagued MV Hondius cruise ship energizes investor focus on the company's vaccine pipeline.

The latest news catalystTwo passengers evacuated from the cruise ship on Sunday tested positive, reinforcing concerns that the outbreak remains active.

The Hondius is moored at a port in Spain's Canary Islands.

On Sunday, passengers were escorted off by personnel in protective gear before being flown home on government and military aircraft.

Seventeen Americans were taken to the University of Nebraska Medical Center, with one sent to the Nebraska Biocontainment Unit and the others placed in the National Quarantine Unit for monitoring.

The outbreak has killed three people, with five additional infections among passengers who had already left the ship.

Last Friday, we asked whether the vaccine trade is back, given news from beleaguered Moderna that it had started work on an early-stage vaccine targeting hantaviruses.

The surge in corporate media coverage of hantavirus has sent Moderna shares up nearly 20%. The latest news on Monday sent the stock up another 7% in premarket trading in New York.

Longer timeframe for Moderna stock:

Polymarket odds of a hantavirus pandemic this year are about 8%.

Hantavirus pandemic in 2026?
Yes 8% · No 92%
View full market & trade on Polymarket

Will hantavirus be enough to change Wall Street's neutral sentiment around the pharma stock? 

Global health officials are honing in on Argentina as the likely source of the virus, since the ship departed from there on April 1. Patient zero was a Dutch man who had traveled in Argentina and South America before boarding the ship. The Dutchman and his wife have since passed.

https://www.zerohedge.com/markets/moderna-extends-rally-after-two-more-cruise-ship-passengers-test-positive-hantavirus

China reaffirms its Iran stance ahead of Trump visit

 Chinese FM spokesperson Guo Jiakun said on Monday that Beijing will maintain a "consistent, constructive role" on Iran ahead of US President Donald Trump's visit to China this week, urging ceasefire efforts and dialogue. "On the Iran situation, China has repeatedly made clear its serious position. The urgent priority is to make every effort to prevent the conflict from reigniting, rather than using the war as a pretext to maliciously link and smear other countries," he said.

Guo also criticized recent US sanctions, stating China "firmly opposes illegal unilateral sanctions that lack basis in international law and are not authorized by the UN Security Council," after measures targeting a Chinese refinery and firms tied to Iran's oil trade.

His comments come after Israeli Prime Minister Benjamin Netanyahu alleged limited Chinese support for Iran's missile production, without providing evidence.

https://breakingthenews.net/Article/China-reaffirms-its-Iran-stance-ahead-of-Trump-visit/66262191

Galectin Phase 2b data show belapectin significantly reduced esophageal varice in MASH cirrhosi

 

Galectin Therapeutics: Hepatology NAVIGATE Phase 2b data show belapectin significantly reduced esophageal varice development in per‑protocol MASH cirrhosis patients

  • Peer‑reviewed Hepatology publication reports belapectin showed a favorable safety profile in the NAVIGATE Phase 2b MASH cirrhosis population.