NeuroRPM obtains FDA 510(k) for Parkinson's monitoring on Apple Watch

NeuroRPM obtains FDA 510(k) for Parkinson's monitoring on Apple Watch



Digital health technology company NeuroRPM has received FDA 510(k) clearance for its AI-enabled remote monitoring app that utilizes an Apple Watch to track common Parkinson’s symptoms such as bradykinesia, tremor and dyskinesia.

Bradykinesia is slowness of movement, and dyskinesia is involuntary or erratic movements. 

The Washington D.C.-based company’s algorithms are embedded in the Apple Watch app and continuously scan the wearable device user’s data to monitor such symptoms and health metrics related to Parkinson’s. 

“We are thrilled to be on the new frontier of digital health with NeuroRPM. By leveraging the power of Apple Watch, we are transforming the way individuals with Parkinson’s disease understand their health, enabling care providers to make more informed clinical decisions which will lead to better health outcomes. We are honored to help drive this revolution in healthcare,” said Atila Omer, president at NeuroRPM. 

THE LARGER TREND

Another digital health company using the Apple Watch to monitor patients with Parkinson’s is brain-data startup Rune Labs

Last year, Rune scored FDA 510(k) clearance for its StrivePD app, which uses Apple’s Movement Disorder API to track tremors and dyskinesia. Patients can also use StrivePD to log their medications, side effects and other symptoms. 

Earlier this month, Rune announced a partnership with BlueRock Therapeutics, a clinical-stage biopharmaceutical company and a subsidiary of Bayer AG, to aid in studying Parkinson’s disease using its StrivePD platform. 

Other companies looking to help people with neurodegenerative movement disorders are Maine-based prescription digital therapeutics startup MedRhythms, which seeks to improve mobility in people with multiple sclerosis, and London-based SERG Technologies, which offers wearable sensor technologies to monitor the symptom severity of Parkinson’s disease.  

Tracy Chu will offer more detail during her HIMSS23 session “Automation Improves Digital Education App Performance.” It is scheduled for Wednesday, April 19 at 11:30 a.m. – 12:30 p.m. CT at the South Building, Level 5, room S505.



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US launches airstrikes in Syria after drone kills US worker

US launches airstrikes in Syria after drone kills US worker



A strike Thursday by a suspected Iranian-made drone killed a U.S. contractor and wounded five American troops and another contractor in northeast Syria, the Pentagon said.

BEIRUT (AP) — A strike Thursday by a suspected Iranian-made drone killed a U.S. contractor and wounded six other Americans in northeast Syria, and U.S. forces retaliated with airstrikes on sites in Syria used by groups affiliated with Iran’s Revolutionary Guard, the Pentagon said. Activists said the U.S. bombing killed at least four people.

While it’s not the first time the U.S. and Iran have traded strikes in Syria, the attack and the U.S. response threaten to upend recent efforts to deescalate tensions across the wider Middle East, whose rival powers have made steps toward détente in recent days after years of turmoil.

U.S. Defense Secretary Lloyd Austin said in a statement that the American intelligence community had determined the drone was of Iranian origin, but offered no other immediate evidence to support the claim. The drone hit a coalition base in the northeast Syrian city of Hasaka. The wounded included five American service members and a U.S. contractor.

Austin said the strikes were a response to the drone attack “as well as a series of recent attacks against coalition forces in Syria” by groups affiliated with the Revolutionary Guard.

Iran relies on a network of proxy forces through the Mideast to counter the U.S. and Israel, its arch regional enemy. The U.S. has had forces in northeast Syria since 2015, when they deployed as part of the fight against the Islamic State group, and maintains some 900 troops there, working with Kurdish-led forces that control around a third of Syria.

The U.S. airstrikes hit targets in three towns in eastern Syria, activists said. Overnight, videos on social media purported to show explosions in Deir el-Zour, a strategic province that borders Iraq and contains oil fields. Iranian-backed militia groups and Syrian forces control the area, which also has seen suspected airstrikes by Israel in recent months allegedly targeting Iranian supply routes.

The activist group Deir Ezzor 24, which covers news in the province, said the American strikes killed four people and wounded a number of others, including Iraqis.

The Syrian Observatory for Human Rights, an opposition war monitor, put the death toll from U.S. strikes at 11 Iranian-backed fighters — including six at an arms depot in the Harabesh neighborhood in the city of Deir el-Zour and five others at military posts near the towns of Mayadeen and Boukamal.

Rami Abdurrahman who heads the Observatory said three rockets were fired earlier Friday at al-Omar oil field in Deir el-Zour that houses U.S. troops, an apparent retaliation to the American strikes.

The Associated Press could not immediately independently confirm the activist reports. Iran and Syria did not immediately acknowledge the strikes, nor did their officials at the United Nations in New York respond to requests for comment from the AP.

Iran’s paramilitary Revolutionary Guard, which answers only to Supreme Leader Ayatollah Ali Khamenei, has been suspected of carrying out attacks with bomb-carrying drones across the wider Middle East.

The exchange of strikes came as Saudi Arabia and Iran have been working toward reopening embassies in each other’s countries. The kingdom also acknowledged efforts to reopen a Saudi embassy in Syria, whose embattled President Bashar Assad has been backed by Iran in his country’s long war.

U.S. Army Gen. Michael “Erik” Kurilla, the head of the American military’s Central Command, warned that its forces could carry out additional strikes if needed. “We are postured for scalable options in the face of any additional Iranian attacks,” Kurilla said in a statement.

Addressing the U.S. House Armed Services Committee on Thursday, Kurilla warned lawmakers that the “Iran of today is exponentially more militarily capable than it was even five years ago.” He pointed to Iran’s arsenal of ballistic missiles and bomb-carrying drones.

Kurilla also claimed that Iran had launched some 78 attacks on U.S. positions in Syria since January 2021.

“What Iran does to hide its hand is they use Iranian proxies,” Kurilla said.

Diplomacy to deescalate the exchange appeared to begin immediately. The foreign minister of Qatar spoke by phone with U.S. National Security Adviser Jake Sullivan as well as Iranian Foreign Minister Hossein Amirabdollahian, the Qatari state news agency report. Doha has been an interlocutor between Iran and the U.S. recently amid tensions over Tehran’s nuclear program.

Austin said he authorized the retaliatory strikes at the direction of President Joe Biden.

“As President Biden has made clear, we will take all necessary measures to defend our people and will always respond at a time and place of our choosing,” Austin said. “No group will strike our troops with impunity.”

The U.S. under Biden has struck Syria previously over tensions with Iran — in February and June of 2021, as well as August 2022.

Dareen Khalifa, a senior Syria analyst with the Brussels-based International Crisis Group, said that while Thursday’s exchange of strikes comes at a sensitive political moment due to the “overall deterioration of U.S.-Iran relations and the stalling of the nuclear talks,” she does not expect a significant escalation.

“These tit-for-tat strikes have been ongoing for a long time,” Khalifa said, although she noted that they usually do not result in casualties.

While “the risk of an escalatory cycle is there,” she said, “I think the Biden administration won’t be eager to escalate in Syria now and will instead have a relatively measured response.”

Since the U.S. drone strike that killed Revolutionary Guard Gen. Qassem Soleimani in 2020, Iran has sought “to make life difficult for U.S. forces stationed east of the Euphrates,” said Hamidreza Azizi, an expert with the German Institute for International and Security Affairs.

“Iran increased its support for local proxies in Deir el-Zour while trying to ally with the tribal forces in the area,” Azizi wrote in a recent analysis. “Due to the geographical proximity, Iraqi groups also intensified their activities in the border strip with Syria and in the Deir el-Zour province.”

The strikes come during the Muslim holy month of Ramadan.

Syria’s war began with the 2011 Arab Spring protests that roiled the wider Middle East and toppled governments in Egypt, Libya, Tunisia and Yemen. It later morphed into a regional proxy conflict that has seen Russia and Iran back Assad. The United Nations estimates over 300,000 civilians have been killed in the war. Those figures do not include soldiers and insurgents killed in the conflict; their numbers are believed to be in the tens of thousands.

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Gambrell reported from Dubai, United Arab Emirates, and Kesten reported from Washington. Associated Press writer Abby Sewell in Beirut contributed to this report.

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© 2023 The Associated Press. All rights reserved. This material may not be published, broadcast, written or redistributed.



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Roundup: Lunit gets new CE mark for AI DBT solution and more briefs

Roundup: Lunit gets new CE mark for AI DBT solution and more briefs



Lunit obtains new CE mark for AI DBT solution

South Korean medical AI company Lunit has received a CE mark under Europe’s latest Medical Device Regulation for its AI software for digital breast tomosynthesis (DBT) analysis.

Called Lunit INSIGHT DBT, the software solution analyses 3D images from DBT, enabling fast and accurate diagnosis of breast cancer. 

In a press statement, Lunit disclosed its plan to start rolling out the software product in Europe by the end of March, noting an uptick in interest. It also announced its plan to begin the process of acquiring the US FDA’s approval for Lunit INSIGHT DBT in the third quarter. The technology has already been approved for commercialisation in South Korea early this year.


Jolly Good creates emergency care VR content with Brigham and Women’s Hospital

Jolly Good has revealed its latest collaboration with Harvard Medical School-affiliated Brigham and Women’s Hospital (BWH).

According to a press statement, their partnership seeks to verify the educational benefits of medical VR and its implementation in North America.

As part of their collaboration, the organisations have developed VR content on emergency care. 

Meanwhile, the Japanese VR company announced that Dr Kei Ouchi, associate professor at Harvard Medical School, has become its medical advisor who will guide its full entry into the US medical market. 


IIT Madras researchers develop coronavirus antibodies database

Researchers from the Indian Institute of Technology Madras (IIT Madras) have built an open-source database of coronaviruses’ antibodies. 

Called Ab-CoV, the online database includes antibody features such as binding affinity and neutralisation profiles, source, and identifying viral proteins and strains. Currently, Ab-CoV has data on 1,780 coronavirus-related antibodies and contains more than 3,200 data points on their features.

“Ab-CoV is an exhaustive repository of antibodies, not just specific to SARS-CoV-2, but also to other members of the coronavirus family, such as SARS and MERS viruses,” Dr Vani Janakirama of the Department of Biotechnology explained.

Based on a press statement, the Ab-CoV database can be used to aid the development of new drugs against emerging variants of SARS-CoV-2, the virus which causes COVID-19. 

“This repository would aid in comparative studies among different neutralising antibodies across coronaviruses and assess their properties and interaction patterns with epitopes on the native and mutant viral proteins. Such an effort eventually would help to gauge the efficacy of these antibodies towards existing and emerging viral variants,” Dr Janakirama added.



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Appeals court blocks Biden's vaccine mandate for federal employees

Appeals court blocks Biden's vaccine mandate for federal employees



NEW ORLEANS — President Joe Biden’s order that federal employees get vaccinated against COVID-19 was blocked Thursday by a federal appeals court.

The 5th U.S. Circuit Court of Appeals in New Orleans rejected arguments that Biden, as the nation’s chief executive, has the same authority as the CEO of a private corporation to require that employees be vaccinated.

The ruling from the full appeals court, 16 full-time judges at the time the case was argued, reversed an earlier ruling by a three-judge 5th Circuit panel that had upheld the vaccination requirement. Judge Andrew Oldham, nominated to the court by then-President Donald Trump, wrote the opinion for a 10-member majority.

Opponents of the policy said it was an encroachment on federal workers’ lives that neither the Constitution nor federal statutes authorize.

Biden issued an executive order last September requiring vaccinations for all executive branch agency employees, with exceptions for medical and religious reasons. The requirement kicked in the following November, and the White House said in January that 98% of federal workers were vaccinated. U.S. District Judge Jeffrey Brown, who was appointed to the District Court for the Southern District of Texas by then-President Donald Trump, issued a nationwide injunction against the requirement in January.

The case then went to the 5th Circuit.

One panel of three 5th Circuit judges refused to immediately block the law.

But, a 2-1 ruling on the merits of the case by a different panel upheld Biden’s position. Judges Carl Stewart and James Dennis, both nominated to the court by President Bill Clinton, were in the majority. Judge Rhesa Barksdale, nominated by President George H.W. Bush, dissented, saying the relief the challengers sought does not fall under the Civil Service Reform Act cited by the administration.

A majority of the full court voted to vacate that ruling and reconsider the case. The 16 active judges heard the case on Sept. 13, joined by Barksdale, who is now a senior judge with lighter duties than the full-time members of the court.

Copyright © 2023 The Washington Times, LLC.





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Idaho abortion law one reason hospital won't deliver babies

Idaho abortion law one reason hospital won't deliver babies



A rural hospital in northern Idaho will stop delivering babies or providing other obstetrical care, citing a shifting legal climate in which recently enacted state laws could subject physicians to prosecution for providing abortions, among other reasons.

Bonner General Health in Sandpoint will discontinue obstetrical services in mid-May. It also cited a decreasing number of deliveries and a loss of doctors among other factors in its decision.

Those pregnant in the city of about 9,000 – with an average annual snowfall of about 60 inches (150 centimeters) – will most likely have to travel about 45 miles (70 kilometers) to Coeur d’Alene for care, or to hospitals farther away in Idaho, Washington and Montana.

The decision to discontinue providing obstetrical services was emotional and difficult, hospital officials said in a news release.

“We have made every effort to avoid eliminating these services,” Ford Elsaesser, Bonner General Health’s Board president, said in the release. “We hoped to be the exception, but our challenges are impossible to overcome now.”

The numbers of deliveries had been declining for years with 265 births recorded at the hospital in 2022, the statement said. Births also have been decreasing nationally and older people have been moving into the Sandpoint area, officials said.

Hospital officials said Idaho’s legal and political climate was partly to blame.

After the United States Supreme Court stripped away constitutional protections for abortion last year, Idaho banned nearly all abortions in measures that subject physicians to prosecution for providing any abortions, even if needed to protect the health of a pregnant patient.

“The Idaho Legislature continues to introduce and pass bills that criminalize physicians for medical care nationally recognized as the standard of care,” the hospital statement said. “Consequences for Idaho physicians providing the standard of care may include civil litigation and criminal prosecution, leading to jail time or fines.”

Physicians could face felony charges and a medical license revocation for violating the law, which the Idaho Supreme Court determined earlier this year is constitutional. A federal judge has stopped Idaho from enforcing the ban in medical emergencies at Medicare-funded facilities.

Highly respected, talented physicians are leaving, according to Bonner hospital officials, who said recruiting replacements would be extraordinarily difficult.

Dr. Amelia Huntsberger, an obstetrician-gynecologist at Bonner General Hospital, moved to Sandpoint in 2012 to work in the area, according to a court filing last year supporting an effort to halt the abortion ban.

She told the Idaho Capital Sun in Boise by email that she will leave the hospital and the state because of the abortion laws and because of the Idaho Legislature’s decision to discontinue the state’s maternal mortality review committee.

“For rural patients in particular, delaying medical care until we can say an abortion is necessary to prevent death is dangerous,” she said in her court filing. “Patients will suffer pain, complications, and could die if physicians comply with Idaho law as written.”

Huntsberger could not be reached for comment by The Associated Press and messages left for her with a hospital spokeswoman were not returned.

Leandra Wright told KREM-TV that after having a baby at Bonner General Health in 2020 she had been looking forward to the birth of her son there in August.

Wright, who lives in the nearby town of Sagle, said she learned about the hospital’s decision from a Facebook post.

“It’s nerve-wracking and stressful and my stomach just kind of drops,” Wright said. “Now I have to reestablish with another place and I have to drive to have my baby.”

Officials at Kootenai Health in Coeur d’Alene said in a Facebook post that anyone who would have given birth at Bonner General Health can go to Kootenai Health’s Family Birth Center, where about 2,200 babies are born each year.

“Leadership from both hospitals are working together to identify any barriers to care for the patient population affected by this closure and are creating solutions to ensure a quality birth experience,” the post said.

Associated Press writer Claire Rush in Portland, Oregon, contributed to this report.

Copyright © 2023 The Washington Times, LLC.





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Gwyneth Paltrow ski collision trial set for family testimony

Gwyneth Paltrow ski collision trial set for family testimony



PARK CITY, Utah — A neuropsychologist who treated the man suing Gwyneth Paltrow over a 2016 ski collision cast aspersions on the testimony of medical experts hired by the celebrity’s legal team – and argued that, as his personal doctor, she was better suited to speak about 76-year-old Terry Sanderson’s post-concussion symptoms.

“A lot of the experts are opining. I feel like I’m the best judge of what happened to him,” Dr. Alina Fong said.

Fong’s videotaped deposition was the first to be shown on the third day of the trial in Park City, the upscale Utah ski resort town where Sanderson accuses Paltrow of skiing so recklessly that she crashed into him, broke his ribs and left him with lasting brain injuries.

Fong said that when she saw Sanderson less than a year after the accident, he had lost his love for life. He was often dejected and crying. And under her care, Sanderson worked tirelessly to rehabilitate the post-concussion symptoms – including pain, headaches and mood shifts. In cross-examination, she accused Paltrow’s attorneys of planting “red herrings” to mislead jurors. Fong said conclusions from Paltrow’s experts – who have yet to testify – were “easily reputable by just going online and looking at the CDC recommendations.”

Sanderson’s two daughters are also expected to testify on Thursday about the lasting effects of the crash as the trial takes on an increasingly personal note on the third day of proceedings.

Attorneys are expected to call Polly Grasham and Shae Herath to the stand and question them about the broken ribs and lasting brain damage that their father Terry Sanderson claims he sustained after his collision with Paltrow seven years ago.


PHOTOS: Gwyneth Paltrow ski collision trial set for family testimony


Neurologist Richard Boehme and Paltrow herself could also be called to testify on either Thursday or Friday.

Sanderson is suing Paltrow for $300,000, claiming she recklessly crashed into him while the two were skiing on a beginner run at Deer Valley Resort in Park City, Utah. In a counterclaim, Paltrow is seeking $1 and attorney fees. The amount of money at stake for both sides pales in comparison to the typical legal costs of a multiyear lawsuit and expert witness-heavy trial.

During the first two days of trial, Sanderson’s attorneys and expert medical witnesses described how his injuries were likely caused by someone crashing into him from behind. They attributed noticeable changes in Sanderson’s mental acuity to injuries from that day.

Paltrow’s attorneys have tried to represent Sanderson as a 76-year-old whose decline has followed a normal course of aging rather than the results of a crash. They have not yet called witnesses of their own to testify, but in opening statements previewed for jurors that they plan to call Paltrow’s husband Brad Falchuk and her two children, Moses and Apple.

Paltrow’s team has previously accused Sanderson of suing to exploit their client’s wealth and celebrity. She is the Oscar-winning star of “Shakespeare in Love” and founder-CEO of the beauty and wellness company Goop.

Her legal team has thus far attempted to poke holes in testimony from Sanderson’s team of experts – and are expected to question his two daughters about their father mentioning Paltrow’s fame, and an email alluding to footage recorded on a GoPro camera that hasn’t been found or included in evidence.

Copyright © 2023 The Washington Times, LLC.





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