Bimi International Medical Price Surges

 The stock price of Bimi International Medical Inc (NASDAQ: BIMI) increased by over 60% pre-market today. Investors are responding positively to the company’s unaudited financial results for the third quarter ended September 30, 2021.

Q3 2021 Highlights:

— Revenues for the three months ended September 30, 2021 increased to $13,777,494 from $3,091,071 in the comparable period in 2020, an increase of $10,686,423, or 345.7%.

— Gross profit for the three months ended September 30, 2021 increased to $2,029,109 from $257,278 in the comparable period in 2020, an increase of $1,771,831, or 688.7%.

— Net income (loss) – The net loss was $1,709,876 and $5,276,241 for the three and nine months ended September 30, 2021. And for the three and nine months ended September 30, 2020, BIMI had a net loss of $1,860,573 and net income of $ 611,090, respectively.

KEY QUOTES:

“We are glad to achieve significant revenue growth in the third quarter. The growth was mainly driven by the increase in sales of wholesale pharmaceuticals. Contributing to the increase in revenues for the three months ended September 30, 2021, was the operations of our recently-acquired five hospitals. Looking ahead, we plan to form partnerships with hospitals with regional reputations, with the goal of making quality medical care more accessible to the wider public, especially in less- developed areas, and to provide health management and healthcare services for both urban and rural residents in a more inclusive and coherent manner.”

https://pulse2.com/bimi-international-medical-nasdaq-bimi-stock-why-the-price-surged-today/

Califf has plenty of unfinished business at FDA

 Robert Califf, President Biden’s new pick to lead the Food and Drug Administration, doesn’t have much to show for his first tenure at the agency.

His grand plans for modernizing the way drug makers and the FDA collect patient data were shelved in 2017 after he left the agency’s top spot. His efforts to ban flavored tobacco products were foiled by the Obama White House. Even his push to finally fix the FDA’s hiring woes still hasn’t been fully implemented.

Now Califf, who Biden formally tapped on Friday to retake the FDA’s top job, will have another shot at delivering on those promises.

“Rob has a unique opportunity to have a more transformational impact that wasn’t possible at the tail end of an administration,” said Mark McClellan, a former FDA commissioner. Califf didn’t achieve everything he wanted to during his first stint at the agency, McClellan added.

It’s unclear if it was his short tenure or something else that kept Califf from delivering on all of his pledges to transform the country’s regulation of food and drugs — he was in the role for just 10 months. But former FDA officials and allies of Califf who spoke with STAT about his first stint at the agency were clear: He has plenty of unfinished business that he’ll want to tackle as soon as he’s confirmed.

Since he left the FDA in 2017, Califf has led clinical policy and strategy at Verily, the life sciences arm of Google parent company Alphabet, where he’s focused on guiding the organization’s efforts to modernize data collection and clinical trials, an endeavor he could continue at the FDA if he is confirmed. But he is best known for creating the world’s largest academic clinical research center, the Duke Clinical Research Institute. As the leader of that institute for a decade, Califf made a name for himself as a vocal advocate for transforming the way drug makers and academic researchers conduct clinical trials.

Amy Abernethy, a former FDA official who now works with Califf at Verily, described him as “one of the grandfathers of clinical trials in America and worldwide” and “a rockstar, grand poobah physician” who not only has advanced how medicine thinks about clinical research, but has put those ideas into practice.

“He really is able to be visionary and maestro at the same time,” Abernethy added.

Below STAT walks through some of Califf’s most notable pieces of unfinished business and how he might tackle those issues this time around. Califf declined an interview request.

Transforming the medical system’s use of data

It’s no secret that Califf is on a lifelong pursuit to transform the way drug makers, doctors, and the FDA use data.

In his 2015 confirmation hearing, he proclaimed the pursuit “my real professional love.” In a 2016 editorial with NIH Director Francis Collins and other top Obama administration officials, he laid out a plan to create a “learning health system” “that takes full advantage of digital data to help us make informed choices.”

Califf had some success implementing his plans at the FDA. He launched an initiative dubbed IMEDS in 2017, which allowed drug makers to mine patient safety data to identify potential red flags with their drugs.

But most of his ideas fizzled.

One of his first initiatives as FDA commissioner was creating a data clearinghouse called the National Medical Evidence Generation Collaborative, which, he thought, could help with everything from recruiting patients for clinical trials to detecting epidemics. Califf and a top deputy released a report outlining their vision for the collaborative, including various ideas on how to structure the organization and fund it but the idea never progressed past a concept paper.

Whether Califf decides to revive the collaborative remains to be seen, but it’s clear he hasn’t abandoned his overarching goal since leaving FDA.

Califf has spent the last several years holding two jobs focused on this exact pursuit: He has led a group at Duke University whose stated goal is to “free the data to enable actionable insights and measurements that will guide implementation efforts across health systems,” and he’s leading a team at Verily with a similar goal: “Making information work better so that healthcare works better.”

Covid-19 also seems to only have strengthened his resolve: Califf has co-authored articles claiming that the pandemic has “laid bare [that] our clinical trials ecosystem is inefficient and siloed and fails at critical moments.”

Fixing the FDA’s broken hiring system

Califf repeatedly told lawmakers and the press in 2016 that the only task more important to him than improving data was fixing the FDA’s broken hiring and HR systems.

Califf promised to work on a “corporate recruiting campaign” to lure top doctors and scientists to work at the FDA, and during his tenure as commissioner, he supported a bill known as the 21st Century Cures Act that gave the FDA the power to pay higher salaries more comparable to those paid in the drug industry and academia.

Five years later, the FDA is still facing many of the same hiring woes. A 2020 report commissioned by the FDA found major flaws in the agency’s recruitment and hiring process. The agency’s HR systems are so bad, the report said, that they prevented the consultant charged with writing the report, Booz Allen Hamilton, from fully reviewing them.

“Stakeholders overwhelmingly consider the hiring process to be inefficient and ineffective,” it states.

A separate May 2020 report from the Government Accountability Office also found that the FDA had yet to use the new hiring powers from the Cures law.

There’s some signs that the FDA’s long-standing hiring woes are improving. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, recently said that her center “has entirely pivoted to using that authority for all eligible positions.”

Getting tougher on tobacco

Califf might not get the credit, but he was actually one of the FDA officials at the center of the agency’s early efforts to regulate e-cigarette companies.

Califf served as the deputy FDA commissioner charged with overseeing tobacco products when the FDA was finalizing the fundamental e-cigarette regulations, and when he stepped up to commissioner, he was also charged with implementing that regulation and defending it in court.

But Califf’s efforts weren’t without missteps. Under his watch, the White House stepped in to overrule the FDA and strike out a provision of a vaping rule that would have banned the flavored products that eventually gave rise to the youth vaping epidemic. Califf told the New York Times in 2019 that he had no idea how the provision was deleted.

Now, Califf, if confirmed, will get a second shot at reshaping the e-cigarette industry: The FDA is currently in the process of reviewing marketing applications for several major e-cigarette makers, including Juul, and is locked in several legal battles that will decide whether smaller vape shops can stay in business.

In recent months, Califf has urged the Biden administration to get tough on tobacco companies.

“Tobacco use is becoming one of the most important markers of disparities in our economy and our health care system,” Califf said during a March panel discussion hosted by STAT. “I hope that this administration will have the courage to fight what will be tough battles.”

He has also laid out a sweeping plan for regulating tobacco products that, if implemented, would constitute the most aggressive plan for tackling tobacco use to date. Califf’s plan, which he detailed in a 2019 blog for the Association of American Medical Colleges, includes lowering the level of nicotine in cigarettes to non-addictive levels, banning all over-the-counter vape products, and mandating that any future e-cigarettes only be sold with a prescription as a way to quit smoking.

It’s unclear, however, whether he would push such a plan if confirmed, especially since the FDA has already given one vape company the green light to sell their products over the counter.

Finally starting from scratch on opioids

Califf didn’t even wait to be confirmed as FDA commissioner before unveiling a sweeping overhaul of how the agency reviews opioid drugs.

The plan, which Califf released while he was technically still serving as deputy FDA commissioner, included promises to reexamine the way FDA judges the benefits and risks of opioid drugs, to convene expert advisory panels any time the FDA considered approving certain new opioids, and to require opioid makers include new warnings on their drugs.

Califf did deliver a number of the reforms shortly after being confirmed. Most notably, the FDA announced in March that it was requiring all immediate-release opioids to include new warnings on their label.

But there are still major tasks Califf started in 2016 that aren’t complete.

Califf’s 2016 plan mandated that opioid makers submit new data testing whether opioids were safe to use long-term. Califf promised the order would “result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder.”

Much of those data still aren’t available. Opioid makers agreed to conduct 11 studies testing everything from the effectiveness of existing tests that spot addiction in patients to the risks of addiction for chronic pain patients treated with opioids, but only eight of the 11 studies have been completed, according to ClinicalTrials.gov.

Califf lamented the lack of good data on long-term opioid use in a March panel hosted by STAT.

Biden’s FDA commissioner, Califf insisted, should “demand that the evidence be generated.”

https://www.statnews.com/2021/11/12/biden-nominates-califf-to-helm-fda-an-agency-where-he-has-plenty-of-unfinished-business/

2nd person to be ‘naturally’ cured of HIV raises hopes for future treatments

 One evening in March 2020, a doctor walked out of a hospital in the Argentine city of Esperanza cradling a styrofoam cooler. He handed it to a young man who’d been waiting outside for hours, who nestled it securely in his car and sped off. His destination, a biomedical research institute in Buenos Aires, was 300 miles away, and he only had until midnight to reach it. That day, while his sister was inside the hospital giving birth to her first child, Argentina’s president had ordered a national lockdown to prevent further spread of the coronavirus, SARS-CoV-2, including strict controls on entering and leaving the nation’s capital. If the brother didn’t make it, the contents of the cooler — more than 500 million cells from his sister’s placenta — would be lost, along with any secrets they might be holding.

The woman was a scientific curiosity. Despite being diagnosed with HIV in 2013, she’d never shown any signs of illness. And traditional tests failed to turn up evidence that the virus was alive and replicating in her body. Only the presence of antibodies suggested she’d ever been infected. Since 2017 researchers in Argentina and in Massachusetts had been collecting blood samples from her, meticulously scanning the DNA of more than a billion cells, searching for signs that the virus was still hiding out, dormant, ready to roar to life if the conditions were right. They wanted to do the same with her placenta because even though it’s an organ of the fetus, it’s loaded with maternal immune cells — a target-rich environment to mine for stealth viruses.

As the scientists reported Monday in Annals of Internal Medicine, they didn’t find any. Which means that the woman, who they are calling the “Esperanza Patient” to protect her privacy, appears to have eradicated the deadly virus from her body without the help of drugs or a bone marrow transplant — which would make her only the second person believed to have cured herself of HIV, without drugs or any other treatment.

“This gives us hope that the human immune system is powerful enough to control HIV and eliminate all the functional virus,” said Xu Yu, an immunologist at the Ragon Institute of MGH, MIT, and Harvard and senior author on the new report. “Time will tell, but we believe she has reached a sterilizing cure.” The discovery, which was previously announced at the Conference on Retroviruses and Opportunistic Infections in March, could help identify possible treatments, researchers said.

Only two times in history have doctors effectively cured HIV — in 2009 with the Berlin Patient and in 2019 with the London Patient — both times by putting the virus into sustained remission with a bone marrow transplant from a donor with a rare genetic mutation that makes cells resistant to HIV invasion. Those cases proved a cure was feasible, but transplants are expensive and dangerous, and donors difficult to find.

“Curing HIV was always assumed to be impossible,” said Steven Deeks, a longtime HIV researcher and professor of medicine at the University of California, San Francisco who was not involved in the study. He and Yu have teamed up in the past to study HIV patients whose immune systems put up a fiercer fight than most. In a Nature study published last year, they found that such individuals had intact viral genomes — meaning the virus is capable of replicating — but they were integrated at places in the patients’ chromosomes that were far from sites of active transcription. In other words, they were squirreled away and locked up inside a dusty corner of the DNA archives.In one patient they examined, a 67-year old California woman named Loreen Willenberg, the researchers didn’t find any intact virus in more than 1.5 billion of her cells. Willenberg had maintained control of the virus for nearly three decades without the use of antiretroviral drugs. If the Esperanza Patient is the second person known to have been naturally cured of HIV, Willenberg is the first.

“With these possible natural cures providing a roadmap for a cure, I am hoping we can come up with an intervention that one day might work for everyone,” said Deeks.

About a decade into the AIDS pandemic, doctors began to find a handful of patients who tested positive for the HIV virus but experienced no symptoms, and were later found to have vanishingly low levels of the virus in their bodies. At the time, these case studies were presumed to be one-offs; maybe these fortunate few caught a glitchy strain of HIV that wasn’t particularly good at replicating, giving their immune systems a rare edge against a disease that was considered universally deadly until the first antiretroviral drugs were developed.

But the more doctors looked, the more such patients they discovered. The past few decades have revealed that people with unusually potent immune responses make up about 0.5% of the 38 million HIV-infected people on the planet. Scientists call these people “elite controllers,” and in recent years they have become the subject of intense international study.

Because their bodies represent a model of a cure for HIV, if researchers can figure out what makes them special, they might be able to bottle it up into medicines, gene therapies or other one-time treatments that could free millions from a lifetime of antiretroviral drug-taking. They might even find ways to boost the immune systems of non-responders — people whose natural defenses were so ravaged by HIV that they’re now hyper-susceptible to a host of other health woes.

One of HIV’s dirtiest tricks is that when it enters a cell — usually a T cell or other immune cell — it makes a DNA copy of itself that integrates into that cell’s genome. So when that cell’s protein-making machinery comes across that bit of viral code, it unwittingly builds more copies of the HIV invader. Antiretroviral drugs disrupt this process, buying patients’ immune systems time to find and kill these hijacked cellular factories. But some DNA copies of the viral blueprint persist — scientists call them proviruses. In theory, they could wake up and start making a virus at any time.

Paula Cannon, a molecular microbiologist who studies HIV and gene editing at the University of Southern California’s Keck School of Medicine, compares proviruses to embers lingering behind the fire of first infection, smoldering for years. If the wind kicks up just right, the fire rages to life. That’s why people need to take antiretroviral drugs for life and why they can never be cured; we have no way of attacking or wiping out these latent integrated HIV genomes. And until recently, there weren’t even good methods for detecting them. But Yu’s group has been at the forefront of developing methods that allow scientists to crack open billions of immune cells and sort through their DNA looking for the smoking remains of infections past.

“This paper is a nice showcase of the level of sophistication of the analyses that can be done now,” said Cannon. “Finding somebody who is an elite controller who not only is currently not exhibiting any HIV RNA viruses in her body, but also doesn’t look like she has the potential to do that any time in the future, isn’t exactly surprising, but it is exciting. The more we study people like this, the more I think some clues are going to come out that we’ll be able to apply to HIV-infected individuals more broadly.”

Deeks said he’s most curious to learn more about what happened during the first few days and weeks after the Esperanza Patient was infected. For some reason, her body didn’t develop antibodies to all the various HIV proteins one might expect. That suggests her natural defenses slammed the brakes on viral replication early, before the virus could spread and overwhelm her immune system. Usually, that only happens if someone starts antiretroviral drugs very early.

It can be a little tricky to study what happened in someone’s body nearly a decade ago. What’s left is the memory of the immune response the Esperanza Patient once mounted. Many of the immune system’s players are transient molecules, and unearthing evidence of them now may prove nearly impossible — like trying to find a fossil of a jellyfish or a flatworm. But Deeks said comparing her DNA or immune cell gene expression to other patients’ might reveal something interesting.

Those are the types of analyses Yu’s group is now working on, together with the Esperanza Patient’s physician, Natalia Laufer, an HIV researcher at El Instituto de Investigaciones Biomédicas en Retrovirus y SIDA in Buenos Aires who studies elite controllers. Their hope is that by combining data from their cohorts with others from around the world — including children in South Africa whose bodies have begun to control the virus after being on HIV drugs for most of their lives — that patterns of protection will begin to emerge that might one day be harnessed to produce cures.

In an email, the Esperanza Patient told STAT that she doesn’t feel special, but rather, blessed for the way the virus behaves in her body. “Just thinking that my condition might help achieve a cure for this virus makes me feel a great responsibility and commitment to make this a reality,” she wrote. Her first child is healthy and HIV-free, and she and her partner are now expecting a second, said the woman, who did not want to be named.

“It is such a beautiful coincidence that Esperanza is where she lives,” said Laufer. “Esperanza” translates, literally, to “hope.” That’s what Laufer said she felt when she met her patient in 2017.

“That individuals can be cured by themselves is a change in the paradigm of HIV,” Laufer said. She added the caveat that  scientists may never be able to say “cure” for sure, because that would require the impossible task of sequencing every one of the patient’s cells. But, Laufer said, “we are seeing indications that it’s possible for some individuals to completely control infection with HIV. And that’s very, very different from what we thought 40 years ago.”

https://www.statnews.com/2021/11/15/scientists-report-finding-second-person-naturally-cured-of-hiv/

Potent Antiplatelet 'Not a Good Idea' for Moderate COVID-19

 P2Y12 inhibitors did not improve outcomes for non-critically ill patients hospitalized with COVID-19, an ACTIV-4a platform trial showed.

Patients randomized to receive a potent antiplatelet, typically atop therapeutic anticoagulation with heparin, actually had numerically fewer organ support-free days through day 21 than those who received usual care without a P2Y12 inhibitor (adjusted OR 0.83, 95% CI 0.55-1.25), reported Jeffrey Berger, MD, of NYU Grossman School of Medicine in New York City, during the virtual American Heart Association meeting.

In a Bayesian analysis, there was a 96% chance of futility and an 81% likelihood that P2Y12 inhibitors were worse than placebo, which prompted early termination of that portion of the trial after enrollment of 562 patients.

And for the composite of death or need for organ support, the P2Y12 inhibitor also trended in the wrong direction (26% vs 22%; HR 1.19, 95% CI 0.84-1.68).

"The data that you've seen does not support the use of these agents in context, but it will be important to address the similar question in higher-risk populations," said study discussant Amy Towfighi, MD, of the University of Southern California in Los Angeles, at the late-breaking clinical trial session.

The trial included a population with confirmed SARS-CoV-2 with at least one higher-risk criterion -- elevated D-dimer, ages 60 to 84, need for more than 2 L/min oxygen, hypertension, diabetes, impaired kidney function, cardiovascular disease, or obesity -- but was still a fairly low-risk group, she noted."On everyone's mind is the fact that most of these patients were on heparin, and certainly we've seen recently that more is less when it comes to anticoagulation," noted session moderator Stephen Wiviott, MD, of Brigham and Women's Hospital in Boston. He questioned whether the findings might have been different if the P2Y12 trial had been done before therapeutic anticoagulation was established as part of standard of care.

ACTIV-4a, together with the REMAP-CAP and ATTACC multi-platform trials, had shown a relative 27% increase in organ support-free days in patients with moderate COVID-19 given therapeutic-dose levels of heparin, but no advantage in critically ill patients. Thus, nearly 90% of patients in both arms of the P2Y12 portion of ACTIV-4a received therapeutic-dose heparin.

"These are all great and important questions, but I think we have to remember we were in the middle of a pandemic. We felt strongly that we needed to use the best standard of care. We needed to answer questions in an expedited manner because of what we're all seeing now. Unfortunately, this is still here and we still need to find our best strategies," Berger responded. "While it would be interesting to investigate P2Y12 inhibitors versus a therapeutic heparin strategy, unfortunately we're not at liberty. We have to go in that order."

The open-label trial randomized patients to 14 days of treatment or until hospital discharge, with ticagrelor (Brilinta) being the preferred P2Y12 inhibitor, which was used by 63% in the active treatment group. Other P2Y12 inhibitors were allowed, but clinicians opted only for clopidogrel (Plavix) for the remainder (90% of whom got a loading dose as recommended in the protocol).

The median duration of use was 6 days, the same as the hospital length of stay after randomization.

Among the secondary endpoints, major thrombotic events or in-hospital death occurred more often in those on a P2Y12 inhibitor (OR 1.42, 95% CI 0.64-3.13), and major bleeding was increased more than threefold (2.0% vs 0.7% with standard care).

The P2Y12 trial is ongoing for critically ill patients, defined as those needing high-flow oxygen, mechanical ventilation, vasopressors, inotropes, or extracorporeal membrane oxygenation support. Two other portions of ACTIV-4a testing the P-selectin inhibitor crizanlizumab (Adakveo) and SGLT2 inhibitors against standard of care are set to start for hospitalized COVID-19 patients.

Disclosures

Berger disclosed no relevant relationships with industry.

Primary Source

American Heart Association

Source Reference: Berger J "P2Y12 inhibitors in non-critically ill hospitalized patients with COVID-19" AHA 2021.

https://www.medpagetoday.com/meetingcoverage/aha/95696

Long-Term LASIK Outcomes in Myopia Beat Out Rival SMILE Procedure

  Among patients who underwent LASIK surgery on one eye and SMILE (small incision lenticule extraction) surgery on the other, the LASIK eyes retained better vision on average, according to long-term results of a prospective study.

Among 21 patients, 92.4% of the LASIK eyes had an uncorrected distance visual acuity (UDVA) of 20/20 or better compared with 79.2% of the SMILE eyes after 4 years (P<0.002), reported A. John Kanellopoulos, MD, of LaserVision Clinical and Research Eye Institute in Athens, Greece, during a presentation here at the American Academy of Ophthalmology (AAO) annual meeting.

Additionally, 62.3% of LASIK eyes had a UDVA of 20/16 or better versus 34.5% of SMILE eyes (P<0.002), he noted.

Two SMILE eyes required photorefractive keratectomy retreatment, which Kanellopoulos described as a high number.

"Both [techniques] were safe and effective in correcting myopia and myopic astigmatism. All patients had a very rapid recovery," Kanellopoulos told MedPage Today.

However, research has suggested that there are differences to consider, he added. SMILE is very effective to improve vision in patients with myopia of -3.00 to -6.00 without astigmatism. "But if there's significant astigmatism, and/or myopia is of a higher refractive error, LASIK is far superior," he noted.

LASIK, which has been used for 30 years, is the grizzled elder of myopia-correcting eye surgeries. The FDA approved the SMILE procedure much more recently, in 2016.

In the study, 21 consecutive patients were assigned to have one eye treated with LASIK and the other with SMILE. Three-month data were published in 2017 and found that "topography-guided LASIK was superior in all visual performance parameters studied, both subjective and objective."

For example, spherical equivalent refraction at ±0.50 D was 95.5% for the LASIK eyes and 77.3% for the SMILE eyes (P<0.002). Residual refraction cylinder (≤0.25 D) was 81.8% and 50%, respectively (P<0.001).

"The main difference between the two techniques likely derives from the eye tracking, cyclorotation compensation, and active centration control in the LASIK technology studied in contrast to the current technology available with SMILE-like procedures," Kanellopoulos wrote.

Other research has suggested that the LASIK and SMILE techniques are more closely matched in terms of visual outcomes. Edward Manche, MD, of Stanford University School of Medicine in California, launched a similar study and reported the results earlier this year at the American Society of Cataract and Refractive Surgery annual meeting.

In this study, 40 consecutive patients were assigned to undergo wavefront-guided LASIK surgery in one eye and SMILE in the other. Among 25 patients, 90% and 85% of LASIK and SMILE eyes, respectively, reached a UDVA of 20/20 or better at 12 months; 70% and 75%, respectively, reached a UDVA of 20/16 or better.

Disclosures

Kanellopoulos disclosed relationships with AJKMD Events, Alcon, Glaukos, i-Optics, KeraMed, ZEISS, and ISP Surgical.

Primary Source

American Academy of Ophthalmology

Source Reference: Kanellopoulos AJ "LASIK vs SMILE for myopia and myopic astigmatism: four-year data of a randomized, prospective, contralateral eye study" AAO 2021.

https://www.medpagetoday.com/meetingcoverage/aao/95698

BioSig Initiates Artificial Intelligence Development Program with Technion

 Company partners with the leading academic institution on research and development of AI-driven methods for atrial fibrillation procedures

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company entered into a feasibility study with The Technion Research & Development Foundation Ltd.

Based in Haifa, Israel, Technion – Israel Institute of Technology is a public research university offering degrees in science, engineering, and related fields, such as medicine, industrial management, and education. Over the years, the Technion established itself as a leading academic institution in Artificial Intelligence (AI). It is currently ranked as number one in AI in Europe and 15th in the world, with 100 faculty members engaged in areas across the AI spectrum.

The feasibility program with BioSig will be led by Asst. Prof. Joachim Behar, Head of the Artificial Intelligence in Medicine Laboratory (AIMLab) at the Technion. Under the terms of the program, the ECG signals supplied by the PURE EP(tm) System, the Company’s signal processing technology for arrhythmia care, will be analyzed in the context of developing AI-powered algorithms for atrial fibrillation ablation procedures.

https://finance.yahoo.com/news/biosig-initiates-artificial-intelligence-development-145200181.html

CDC adds four more European destinations to high-risk travel list

The Centers for Disease Control and Prevention (CDC) added four more destinations to its highest risk category for travel as COVID-19 surges impact Europe. 

The Czech Republic, Hungary, Iceland and Guernsey were all added to the CDC's "Covid-19 Very High" Level 4 category.

Level 4 categorization means that these countries or destinations had more than 500 cases of COVID-19 per 100,000 people for each of the past 28 days. The island of Guernsey, a channel island between Great Britain and France, has less than 100,000 residents. It received the designation because it had more than 500 cumulative new cases over the past 28 days.

"Avoid travel to these destinations. If you must travel to these destinations, make sure you are fully vaccinated before travel," the U.S. agency's website said of the destinations. 

The Czech Republic has a daily case average of nearly 11,000 infections.

Hungary's daily new cases hover around an average of 7,200 while Iceland's was at just 167, according to The New York Times. Guernsey's government reported that the island currently had over 400 active COVID-19 cases. 

As of this week, over 80 destinations are listed in the highest risk category. The agency also recommends getting fully vaccinated and masking on transportation while traveling regardless of one's destination. 

The designation comes as the U.S. just opened its borders to international travelers earlier this month after more than 18 months of COVID-19 travel restrictions. Under this new policy, fully vaccinated international travelers are permitted to enter the U.S. as long as they provide proof of vaccination and show a negative COVID-19 test that was taken within three days of travel. 

https://thehill.com/policy/healthcare/public-global-health/581726-cdc-adds-four-more-european-nations-to-high-risk