Medtronic’s brain-reading stimulator nets FDA approval

The FDA has approved Medtronic’s latest deep-brain stimulation implant, featuring the ability to read, capture and transmit a patient’s brain signals during therapy.

This would allow for more personalized treatments for patients with Parkinson’s disease, tremors, epilepsy, dystonia or obsessive-compulsive disorder by correlating readings with patient-recorded actions and symptoms, as well as medication intake, and then tailoring their neurostimulation accordingly, the company said. A customized Samsung mobile device also allows patients to manage their own therapy.

“For the first time, this technology gives clinicians feedback directly from the DBS patient’s brain,” said Mike Daly, vice president and general manager of Medtronic’s brain modulation business. “With such data-driven, patient-specific insights, we believe it can change the standard of care.”

The Percept PC DBS system with its BrainSense technology will first be used at the Mayo Clinic. Shaped like a small pacemaker, the main device is placed under the skin of the chest, with small electrical leads connected to different regions of the brain.

The system is also compatible with full-body MRI scans and carries an improved battery life compared to the company’s older Activa PC neurostimulator with a smaller design.

In January, Medtronic received a CE mark for the Percept system with plans to begin implantations in Western Europe.

https://www.fiercebiotech.com/medtech/medtronic-s-brain-reading-stimulator-nets-fda-approval

U.K.’s RenalytixAI aims for dual listing with $86M Nasdaq IPO

The Cardiff, U.K.-based developer of artificial intelligence-based kidney diagnostics, RenalytixAI, is looking to become dual-listed on both the Nasdaq and London’s AIM stock exchange.

The two-year-old company filed this week for a new global offering and an $86 million U.S. IPO, under the Nasdaq ticker RNLX. RenalytixAI was previously listed in London under the symbol RENX, with a market cap of £303 million, or about $377 million U.S. according to Renaissance Capital.

At the same time, the company announced upcoming changes to its board, with its non-executive chair, Julian Baines, and non-executive director Richard Evans planning to step down before the completion of the Nasdaq dual-listing. Non-executive director Christopher Mills will become interim chair and oversee a search for replacement directors.

RenalytixAI has been developing algorithms that use proprietary blood-based biomarkers, genomic information and electronic health record data to derive an individual patient’s risk score for chronic kidney disease and progressive declines in function over five years, on a scale of 0 to 100. The company plans to launch its KidneyIntelX offering in the U.S. as well as the U.K., European Union and China.

The company first licensed AI tech from the Icahn School of Medicine at Mount Sinai in May 2018. And by the third quarter of this year, RenalytixAI plans to begin a commercial launch and patient testing in partnership with Mount Sinai Health System, according to the company’s prospectus filed with the SEC.

Earlier this month, the company received approval from New York State Department of Health to provide commercial testing to state residents. With its CLIA laboratories in New York and Utah, RenalytixAI said it is now set up to provide testing services in 47 states, and expects to receive licenses for California, Maryland and Pennsylvania by the end of the year.

https://www.fiercebiotech.com/medtech/uk-s-renalytixai-aims-for-dual-listing-86m-nasdaq-ipo

American, United Airlines Will Go Back To Packing Flights Despite Covid-19

Exsqueeze me?

The U.S. just experienced the highest one-day totals of new reported Covid-19 coronavirus cases since April. What then will United Airlines and American Airlines be doing starting in July? How about going back to fully booking their flights and in turn squeezing people closer together?

Yep, that’s apparently what both airlines have chosen to do.

Not 80%. Not 90%, But 100%. If you can’t quite read the section of the June 26 American Airlines statement accompanying the tweet above without a magnifying glass, here are the first couple sentences: “As more people continue to travel, customers may notice that flights are booked to capacity starting July 1. American will continue to notify customers and allow them to move to more open flights when available, all without incurring any cost.”

Uh, “book to capacity” on an airplane is not exactly social distancing. In fact, it can be quite the opposite, more like social nearing or social squeezing or social “your-elbow-is-on-my-elbow”-ing.

When it comes to the Covid-19 coronavirus, proper social distancing means staying at least one Ryan Gosling (who is six feet tall) away from all others. Keep in mind that this would be a lying Gosling, meaning a Gosling lying on the ground rather than standing or sitting. Unless United Airlines and American Airlines have somehow drastically changed the design of their planes, you can’t fit one Gosling between each of the seats. Heck you may not even be able to fit a regular gosling (the feathered kind) in those spaces.

Whatever happened to maintaining social distancing on flights? After all, back in May, back in May, (roughly one and a half missed haircuts ago) I wrote for Forbes about how United Airlines came under fire for not adhering to own social distancing promises. United Airlines had stated in an email to customers that they were “automatically middle seats to give you enough space on board.” When a doctor on board a United Airlines flight from Newark to San Francisco tweeted a photo of the cabin, it looked as if the airline had blocked those middle seats with, drum roll please, other passengers.

It didn’t seem like you could fit too many Goslings between people on that flight. Seeing this on social media left numerous people wondering whether they should even trust any future assurances from the airline that the middle seats would remain empty. Well, apparently starting next week there won’t be need to wonder anymore. Expect those middle seats to be filled if the airline can fill them.

Would this really be a good thing to do right now? A number of states are experiencing surges in Covid-19 coronavirus cases, including big states that may have quite a few air travelers such as Texas, California, and Florida. Will this policy change be “plane” risky? After all, isn’t there a decent chance that some people who are contagious will make it on to United and American Airlines planes?

It didn’t seem like you could fit too many Goslings between people on that flight. Seeing this on social media left numerous people wondering whether they should even trust any future assurances from the airline that the middle seats would remain empty. Well, apparently starting next week there won’t be need to wonder anymore. Expect those middle seats to be filled if the airline can fill them.

Would this really be a good thing to do right now? A number of states are experiencing surges in Covid-19 coronavirus cases, including big states that may have quite a few air travelers such as Texas, California, and Florida. Will this policy change be “plane” risky? After all, isn’t there a decent chance that some people who are contagious will make it on to United and American Airlines planes?

Additionally, according to the announcement, the airline will “limit flight privileges for customers who refuse to wear a face covering without a medical reason.” It’s not completely clear what “limit flight privileges” will mean. This could offer a fair amount of wiggle room, just like “limiting bathroom privileges” typically doesn’t mean that you can’t go to the bathroom at all. Regardless, the announcement claimed that “wearing a face covering continues to be one of the most important ways travelers can protect themselves and others while flying.” This sounds reasonable, except that wearing a face covering is more to protect others from you than you from others.

These are all good infection prevention measures to have in place. It’s certainly better to hear that the planes will be cleaned more thoroughly than a bachelor’s pad. But will all of these measures really be enough to protect you from the Covid-19 coronavirus? Getting dressed doesn’t mean just wear a scarf, a beret, and boots. That could leave you quite exposed. Similarly, protecting you from the Covid-19 coronavirus doesn’t mean employing a bunch of infection control measures without doing the most important thing of them all: social distancing. Even with all of those other measures in place, what happens if you end up sitting very close to one or two people who are contagious for one, two, three, or more hours in a crowded indoor environment?

Say they were to wear face coverings quite diligently. That could help for brief periods of time. But the longer you remain in closer contact, the greater the chance that something will end up leaking out through their face coverings. Plus it can be challenging to wear a face covering for such a lengthy period of time without occasionally adjusting and maybe even taking off the covering. Heck there are people who complain about wearing a face covering for even 10 minutes during a visit to a coffee shop.

The American Airlines announcement mentioned another new policy as well. Starting June 30, they will require passengers to certify during the check-in process that they “have been free of COVID-19 symptoms for the past 14 days.” But how many people will this process really catch? How many people will be at the check-in stage and say, “oh, thanks for the reminder. That’s right I do have Covid-19 symptoms. What was I thinking? I had better not fly right now.” Plus, a sizable proportion (somewhere between 30% and 60%) of people who are contagious don’t even have symptoms. They may never have symptoms or be on their way to developing symptoms.

All of these other measures won’t fully compensate for the one thing that you shouldn’t be doing these days, staying very close to others for an extended period time in an enclosed location. In fact, many of these other measures would work a whole lot better when combined with social distancing.

It’s unlikely that public health experts approached the airlines and said, “hey, people are not squeezed together tightly enough on airplanes. You know what would be great? Start packing your airplanes to full capacity.” Instead, financial considerations are likely driving these booking policy changes. After all, mo people, mo money. As long as government bodies such as the U.S. Federal Aviation Administration (FAA) don’t guide or even regulate booking policies, each airline may make decisions based largely on management and shareholder business interests.

Yeah, packing airplanes doesn’t seem to be airing on the side of caution. We’ve already seen how hastily re-opening businesses may have led to surges in Covid-19 coronavirus cases in various states. As a result, many businesses have had to close back down. Could something similar happen with hastily re-opening airplane seats?

With the first wave of the Covid-19 coronavirus pandemic still continuing in the U.S., try to avoid air travel if you can. If you must travel by air, try to take a flight that will allow you stay at least one Gosling away from everyone else for at least most of the flight. Just because you are up in the air, doesn’t mean that your chances of maintaining proper social distancing should be as well.

https://www.forbes.com/sites/brucelee/2020/06/28/american-united-airlines-will-go-back-to-packing-flights-despite-covid-19-coronavirus/#60f3f4953f30

5 new study findings on kids with COVID-19

In the first four months of the pandemic, only a small percentage of children with COVID-19 needed intensive care, a review of 131 studies finds.

Published in EClinicalMedicine, a journal of The Lancet, the review included 131 studies from 26 countries published between Jan. 24 and May 14. Together, the studies include 7,780 pediatric patients. The majority of the studies were from China, but the largest study that was included was a case series of 2,572 patients reported by the CDC.

Five study findings:

1. About 3.3 percent of the patients were admitted to intensive care units.

2. Seven patients (0.09 percent) died.

3. About 5.6 percent suffered from co-infections, such as influenza, in addition to COVID-19.

4. Eleven children (0.14 percent) met the criteria for pediatric multisystem inflammatory syndrome.

5. Nineteen percent of the patients were asymptomatic.

https://www.beckershospitalreview.com/patient-safety-outcomes/5-new-study-findings-on-kids-with-covid-19.html

Tech pros increasingly seeking healthcare, pharma jobs – Novartis study

Many tech professionals feel positively about seeking new jobs in the healthcare and pharma industries amid the pandemic, according to survey results released June 25 from Swiss drugmaker Novartis.

The survey, which was conducted from May 21 and June 3, involved 2,502 tech professionals in the U.S., the U.K., Germany, China and India. Here are some of its notable findings:

• 49 percent of respondents reported they would consider switching to the healthcare industry.
• 49 percent of respondents reported they would consider switching to the pharma industry.
• 48 percent of respondents cited the opportunity to solve real-world problems as a motivator to join a new health-focused industry.
• 49 percent of respondents cited the opportunity to improve quality of care as a motivator to join a new health-focused industry.
• 49 percent of respondents cited the opportunity to make systems more efficient as a motivator to join a new health-focused industry.
• 52 percent of respondents cited the opportunity to innovate through tech as a motivator to join a new health-focused industry.
• 72 percent of respondents reported thinking the healthcare industry has been effective in handling the pandemic.
• 85 percent of respondents reported believing that the application of data science has been crucial to healthcare’s COVID-19 response.
• https://www.beckershospitalreview.com/digital-transformation/tech-professionals-are-increasingly-seeking-healthcare-and-pharma-jobs-study-finds.html

West Village, Upper East Side, Astoria top NYC areas for social-distancing violators

It’s beer goggles on, masks and inhibitions off, in these party spots across the city which have netted the most complaints about people flouting social-distancing rules.

Millennial havens in the West Village, Upper East Side and Astoria led the list of ZIP codes with the most 311 callers reporting social distancing violations from June 11-13 and 18-20, according to city data. Those six days brought in 2,480 complaints, with 1,208 during the first weekend and 1,272 from Thursday to Saturday last weekend.

The reports prompted Gov. Andrew Cuomo on June 14 to scold bar and restaurant owners, local government officials and revelers .

“These are not hard-to-spot violations. People send videos of these violations,” he said. “I’m not going to allow situations to exist, that we know have a high likelihood of causing an increase in the virus . . . Local governments, do your job.”

Snitches spotted people getting too close in the West Village’s 10014 ZIP code 82 times during the two weekends, more than any other New York City neighborhood, data show. A bar-lined two-block stretch of Hudson Street netted eight complaints.

On Friday afternoon, revelers were seen within six feet of each other outside the White Horse Tavern atop a crowded makeshift patio set up between the bike lane and road as Phase 2 began this week and businesses were allowed to expand outdoor seating.

The Upper East Side’s 10028 ZIP code drew 80 social-distancing complaints, with 28 along Second Avenue from 68th to 95th — which is more than one per block.

Here is the full list of the Top 10 neighborhoods (by ZIP code) with the most  311 complaints of people shirking social-distancing rules during the past two weekends:

• West Village (10014): 82 complaints
• Upper East Side (1002): 80 complaints
• Astoria (11103): 73 complaints
• Bay Ridge (11209): 63 complaints
• Soho (10012): 61 complaints
• Astoria (11106): 54 complaints
• Williamsburg (11249): 54 complaints
• Hell’s Kitchen (10019): 51 complaints
• East Village (10009): 47 complaints
• Kips Bay/Murray Hill (10016): 44 complaints

Source: New York City Department of Information Technology

https://nypost.com/2020/06/27/west-village-is-top-nabe-for-social-distancing-violations/

Geochemistry test can ID osteoporosis earlier than current ‘gold-standard’ test

In a novel collaboration, clinicians and geochemists have developed a test that can show the presence of osteoporosis before it has a noticeable clinical effect on bones. The methods are still being refined, but initial results show that it is more sensitive than the standard DXA osteoporosis scans, and can identify the condition earlier. Researchers are now working to develop the test for routine clinical use. This work is presented at the Goldschmidt conference, amd the presentation includes work published in the peer-reviewed journal Bone Reports.

Lead researcher Dr. Anton Eisenhauer (GEOMAR Helmholtz Centre for Ocean Research Kiel, Germany), said, “Bones are made of calcium and phosphorus, with organic components like the protein collagen. About 99% of the body’s calcium is found in bones, but this is continually being absorbed and resorbed: The calcium balance of bone can be seen by monitoring calcium isotope composition in blood and urine. We have developed a test that measures and identifies the type of calcium in the blood and in urine—this originates from the bones, and this in turn indicates what’s happening in the bones.”

The new system was developed out of a standard technique for measuring trace elements and their isotopes in geochemistry. Geochemists routinely identify and quantify elements with different stable isotopes (atoms with different numbers of neutrons). Dr. Eisenhauer is a geochemist, and normally works on analyzing coral shells. He said, “This is really an example of a clinical test coming out of very sophisticated science. I came to this through my work in measuring calcium in corals, but one of the first applications of this technique was a NASA-sponsored project to measure and anticipate bone loss in astronauts.”

The researchers studied samples from a group of 80 women, 14 of whom had osteoporosis (as measured by the DXA test). They found that the ratio of calcium-44 to calcium-42 (⁴⁴Ca/⁴²Ca) was significantly lower in the blood and the urine of women with osteoporosis. “There were significant differences in the ratios of these two calcium isotopes if you had osteoporosis,” said Eisenhauer.

Osteoporosis happens when bones become less dense, making them weaker and more prone to fracture. This mainly affects women, especially after the menopause. The standard osteoporosis test uses X-rays to measure the density of two bones, usually the hip and spine.

“One of the beauties of the new method is that it measures calcium in the blood or urine, and so we get a picture of what’s happening in the whole skeleton, not just the bone and spine,” said clinical lead, Dr. Rukshana Shroff (Consultant Nephrologist, Great Ormond Street Hospital for Children NHS Foundation Trust, London). “Importantly, we have found that we don’t need to wait until bones become weaker to see the changes caused by calcium loss. This test allows us to see bones losing calcium more or less in real time, which means that we can pick up osteoporosis earlier and treat it.”

The initial results showed that the test picked up 100% of the osteoporosis cases found by DXA. It seemed to overestimate the number of women diagnosed with osteoporosis who did not have the condition in comparison to DXA, but a two-year follow-up showed that in fact, many of these women went on to develop the disease.

“This means that it’s likely to be better at identifying the condition than the current method, but the work needs to be repeated with a bigger sample so we can be sure just how selective the test is,” said Eisenhauer. “The test is already being used in routine settings. However, it’s still expensive due to the more sophisticated sample preparation and the use of high resolution plasma mass spectrometers, but we anticipate the price will drop with increasing use—this happened even with DXA scanners when they were introduced. It’s likely that the first practical use of these tests will be to measure how bone recovers when treated with bone building drugs. No other method can show this so sensitively and in a reasonable time.”

In the U.S., around 10 million people have osteoporosis and 44 million have low bone density. Osteoporosis affects the bones of around 22 million people in the EU. About 85% of these people are women. It has a huge financial impact, anticipated to cost the six major European countries nearly €47 billion every year. This will increase as the population ages. Osteoporosis can be treated, but early diagnosis is important.

Professor Jon Tobias, professor of rheumatology at the University of Bristol, who was not involved in the study, said, “It’s interesting that technology from earth sciences designed to measure trace elements have the potential for medical application such as diagnosing osteoporosis, but more research is needed before any firm conclusions can be reached.”

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More information: A. Eisenhauer et al. Calcium isotope ratios in blood and urine: A new biomarker for the diagnosis of osteoporosis, Bone Reports (2019). DOI: 10.1016/j.bonr.2019.100200

https://medicalxpress.com/news/2020-06-geochemistry-osteoporosis-earlier-current-gold-standard.html