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With the Invisible Trial System, St. Jude Medical has removed these barriers, allowing patients to more effectively evaluate their SCS therapy. The system relies on Bluetooth® wireless technology to provide patients a safe, secure and entirely wireless SCS trial experience. Rather than a complex controller, the St. Jude Medical Invisible Trial System provides patients with a more intuitive iPod touch™ digital device as a controller, while physicians will utilize an iPad mini™ digital device to program and evaluate their patient’s therapy.
“Patients undergoing SCS trials consistently tell us about challenges they find in navigating the SCS trial system, from programming the device, to discomfort from the programming cables, to management of both issues. These hindrances may impede the integration of the technology into their daily activities, which shifts their focus away from evaluating the effectiveness of SCS therapy,” said pain specialist Dr. Jason E. Pope, president of Summit Pain Alliance in Santa Rosa, Calif. “By providing a discreet trial system, St. Jude Medical will help patients focus more on their potential pain relief and functional improvements, and less about the burdens common to traditional trial systems.”
One of the key system features of the St. Jude Medical Invisible Trial System is the use of a small external pulse generator (EPG) as the system’s power source. Because the EPG uses Bluetooth wireless technology to communicate between the patient’s iPod touch controller and the stimulation system, the overall device profile has been reduced so the system can be worn discreetly under a patient’s clothing. The effect is that the system feels essentially “invisible” to the wearer, providing a more comfortable trial experience that allows patients to focus entirely on their system’s therapeutic impact during their trial.
“When we developed the new Invisible Trial System, we took into account physician and patient feedback that current trial systems were in some cases preventing patients from adequately assessing their therapy,” said Eric S. Fain, M.D., group president of St. Jude Medical. “By providing a more patient-friendly option, we think we can shorten the learning curve related to trial programming devices and allow patients to better assess the potential pain relief they’re receiving from spinal cord stimulation.”
The iPod touch controller offers patients a simple, familiar platform to adjust their therapy. An iPad mini tablet is used by the patient’s physician to set the programming parameters. The programmer also displays trial usage data from the EPG and allows the physician to print or email the data in PDF format. Bluetooth wireless technology safely and securely communicates wirelessly between the EPG and patient and physician devices, eliminating the programming trial cable and thus increasing the patient’s comfort.
Note: Apple, iPod touch and iPad Mini are trademarks of Apple, Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.
About the St. Jude Medical Chronic Pain Portfolio
Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact mood, personal relationships, work productivity, and activities of daily living. St. Jude Medical offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation (SCS) and radiofrequency ablation (RFA).
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit chúng tôi or follow us on Twitter @SJM_Media.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2024 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2024. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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Reality TV star Kim Kardashian was recently forced by the FDA to take down a misleading Instagram post about a drug, but the FDA has been cracking down on social media posts long before Kardashian.
Kardashian is pregnant with her second child with rapper Kanye West, which I hope she either names Key, SxS, or Wild Wild. Meanwhile, she has also become a paid spokesperson for a prescription morning sickness drug called Diclegis, and began endorsing it on her various social media accounts. The FDA found one of her Instagram posts to be against its guidelines for promoting drugs through social media platforms and sent a warning letter to the pharmaceutical company Duchesnay, Inc.
The Instagram post in question, which was sent out to Kardashian’s 43 million followers and included a photo of her gently holding a white bottle of Diclegis, read:
The FDA states that this promotion is misleading due to the fact that the post contains no mention of the drug’s side effects such as drowsiness, or that it has not been studied in woman with hyperemesis gravidarum, a rare complication of pregnancy that causes prolonged vomiting and severe weight loss.
There are four draft guidelines that the FDA released to address promotion of drugs and medical products on social media, the most recent and comprehensive draft being released in June 2014. The main requirement for social media posts written by the company or one of their spokespeople is that the main risks be included along with a hyperlink to more in-depth information about the product. The Kardashian Instagram post may have included a link to the drug’s website, but that didn’t quite cut it. The FDA’s warning letter says:
This is far from the first instance of the FDA issuing a warning to a company for posting misleading information about its products on social media. Between October 2014 and March 2024 the FDA sent out at least six warning letters to companies posting unapproved claims on Facebook. One of the warning letters was sent to Vitalab Co., Inc. for Facebook posts that claimed some of its “Vit-Ra-Tox” products could be used for “bacterial food poisoning,” or “repair broken bones.” None of those claims has been approved by the FDA.
Even as far back as December 2012, the FDA sent a warning letter to AMARC Enterprises, a supplement marketer, for “liking” an unapproved claim about one of their products that someone wasn’t paid to write. That’s the only instance of the FDA considering a “like” to be an endorsement and issuing a warning letter.
“We can’t speculate on any future actions, But what I can tell you, is that the FDA understands that today, various social media platforms increasingly enable drug and device manufacturers to more actively engage with consumers and healthcare professionals about the products they manufacture and market,” the FDA said in an email. “When manufacturers promote their medical products to consumers and health care providers using social media platforms, FDA’s statute and regulations require that such communication be truthful, non-misleading and balanced.”
You can find all of the FDA’s warning letters here, although they don’t all deal with social media. You can also browse through some of our favorite drugs, supplements, and foods that the FDA has recalled from the market.
Judge’s Ruling to Invalidate Abortion Pill Ruling Could Impact Other FDA-Approved Drugs
On Friday, a federal judge in Texas ruled to invalidate the FDA’s 23-year-old approval of the abortion pill mifepristone in an unprecedented move, says Nicole Huberfeld, Edward R. Utley Professor of Health Law, Bioethics & Human Rights at the BU School of Public Health and a professor at the School of Law. Brigette Supernova / Alamy Stock Photo
HealthcareJudge’s Ruling to Invalidate Abortion Pill Ruling Could Impact Other FDA-Approved Drugs The abortion drug mifepristone is still lawful and available for now, says BU LAW professor, but she calls the ruling “part of the broad strategy to make it nearly impossible to have an abortion in the United States”
No federal court has ever “second-guessed the science” behind the US Food and Drug Administration’s approval of a medication, says Boston University health law professor Nicole Huberfeld—until now.
On Friday, a federal judge in Texas ruled to invalidate the FDA’s 23-year-old approval of the abortion pill mifepristone in a decision that shocked many legal experts. Huberfeld, who is the Edward R. Utley Professor of Health Law, Bioethics & Human Rights at the BU School of Public Health and a law professor in the School of Law, says it was an unprecedented move that calls into question more than just the future of medical abortions.“This is a clear separation-of-powers problem,” she says. “The court—and really, this judge—doesn’t have the expertise to second-guess the FDA in this way.”
The ruling concerns mifepristone, the first of a two-drug protocol for a medical abortion. And while Judge Matthew J. Kacsmaryk’s decision came down on April 7, both drugs typically used during the procedure (the other is misoprostol) are still available throughout the United States. Kacsmaryk stayed, or delayed, his order for seven days to give the federal government time to appeal the ruling.
That didn’t take long. The Department of Justice immediately filed an intent to appeal, calling the decision “extraordinary and unprecedented.” And, in a statement following Kacsmaryk’s decision, President Joe Biden said that the “court in this case has substituted its judgment for FDA, the expert agency that approves drugs. If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
Additionally, some states, including Massachusetts, have taken preemptive steps to stock up on the two drugs required for medical abortions. Governor Maura Healey said Monday that the state put in an order for close to two years’ worth of mifepristone last week, before Kacsmaryk’s decision even came out.
Still, the ruling rattled many.
“This is really just an attack on bodily autonomy,” says Shana Weitzen (Pardee’25), who is the Planned Parenthood liaison for BU Students for Reproductive Freedom. “It’s not about the drug. This is going to be an attack across the country. It can be a really scary time, but people have to remain hopeful and have to educate themselves and learn about the organizations that are working on the ground.”
While for now the target is abortion care, this ruling (if it stands) could reverberate far beyond one drug, Huberfeld says. Already, more than 400 executives from the pharmaceutical industry have signed on to a statement condemning Kacsmaryk’s ruling, writing that it “creates uncertainty for the entire biopharma industry.”
“They’re right to be alarmed,” Huberfeld says. “You could see the same thing play out in debates over vaccines or other medications. So, I do think that this is potentially problematic in a number of dimensions.”BU Today spoke with Huberfeld further about the ruling, and its impact across healthcare.
A with Nicole Huberfeld
Just an hour after Judge Kacsmaryk ruled on this case, another federal judge in Washington state issued what seems like a contradictory ruling in a separate case. What does that mean?
Let’s go back—you mentioned that the doctors in the Texas case wouldn’t prescribe mifepristone. Why not?
Is that rare? Can you explain that a bit more?
It’s not uncommon for lawyers to try to figure out where they’re going to get a favorable ruling, and to try to locate litigation where they think they may get favorable judges. So, broadly speaking, the judges in the Ninth Circuit, or California, tend to be more progressive than the judges in the Fifth Circuit, or Texas. So, forum shopping, as it gets called, is not new, and it’s not unusual. But this is a little different in that the strategy was so specific. This organization of anti-abortion doctors was specifically formed in this town of Amarillo, where only one federal judge sits, so that this judge—who was well known to be a person who has been anti-abortion his entire life—would hear this case.
So, to what extent is this decision a testament to that anti-abortion belief, as opposed to a reaction to the merits of the case?
The decision is riddled with language that reflects the anti-abortion movement. It contains nonscientific language—instead of using “medication abortion” or “medical abortion,” the judge uses the phrase “chemical abortion,” which is not how it gets referred to by doctors, for example. There are also instances of calling an embryo or fetus an “unborn human being.” So, the language is very much anti-abortion movement language. And that is reflective, I think, of the totality of the opinion, which is written in such a way that this judge appears to be outraged that the FDA ever would have considered approving the mifepristone in the first place.
Can you put this case within the context of that broader anti-abortion movement?
It is part of the broad strategy on the part of anti-abortion organizations to make it nearly impossible to have an abortion in the United States. So, that’s the big picture. This is their long-term, 50-year strategy. And this is just one front in that strategy.
What comes next? Do you see this going to the US Supreme Court?
It certainly could. I mean, it is irreconcilable, the decisions that are being issued by lower federal courts, and that is a standard circumstance in which the US Supreme Court would take a case. But let’s be clear, as of right now, mifepristone is available. I think people need to know that: this is still lawful and available.
Lindsay Shachnow contributed to this report.
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Having been charmed by a plethora of all-new features, you installed iOS 17 to try out the latest add-ons. However, even before you could take a thorough look at the new features, your iPhone got plagued with a number of frustrating issues such as rapid battery drain and sluggishness.
The issues troubled you so much that you decided to downgrade from iOS 17 beta to iOS 16. If my guesswork is spot on, you have arrived at the right post to return to iOS 16.
Securely Downgrade From iOS 17 Beta to iOS 16 Without Losing Any Data
Before going for the kill, make sure to check out the requirements and the important things beforehand.
Things to Know Before Downgrading from iOS 17 to iOS 16
To downgrade from iOS 17 beta to iOS 16, you’ll need a Mac or PC.
Make sure you have a strong and stable internet connection.
It is not possible to restore the iOS 17 backup to iOS 16. Therefore, be sure to manually back up your photos, videos, files, and more to storage services like iCloud Drive, Google Photos, and One Drive. Later, you can download these again on iOS 16.
Ensure that you have the backup of your iPhone before you installed iOS 17.
You’ll have to set your iPhone as new after you downgrade if there isn’t a backup for iOS 16.
It’s also important to note if you have upgraded your Apple Watch to watchOS 10, you won’t be allowed to use your Apple Watch with your iPhone. It’s because Apple doesn’t let users downgrade their Apple Watch manually. For downgrading the Apple Watch to a previous version of watchOS, you need to send it to Apple. Very disappointing but that’s the harsh reality you must deal with.
Remove iOS 17 Beta from iPhone and Go Back to iOS 16
To begin with, launch Finder on your Mac or iTunes on your Windows computer.
Then, you need to connect your iPhone or iPad to your computer with a USB cable.
Now, enter recovery mode on your device. Press and swiftly let go of the Volume Up button. Then, press and release the Volume Down button. After that, you have to press and hold the power button until your device restarts. Keep the power button pressed until your device enters recovery mode.
Next up, it’s time to let the restore finish without any obstruction at all. After it’s done, restore your device using the latest backup of
Once again I would like to reiterate that you will not be able to restore your iOS 17 backup on iPhone running iOS 16. Hence, do not fail to fully back up your data to your favorite cloud service before making the move.
Talking about iOS 17, it is a major upgrade without any doubt whatsoever. As for the problems that have plagued the beta software, you should be fully aware of the fact that annoying issues are part and parcel of beta software.
You might also like to read: How to Customize Photo Options When Sharing an Image in iOS 17
iOS 13 leak previews huge changes – and iPad Pro could come of age
Apple won’t be talking about iOS 13 until WWDC 2023 in a few months time, but that hasn’t stopped a huge leak of features for the new iPhone and iPad software from dropping today. After a mixed reaction to iOS 12 last year, widely seen as Apple’s attempt to deliver more and over-promise less, it seems iOS 13 will crank up the number of new features.
In doing so, it looks like some of the most frustrating elements of iOS as it currently stands will be addressed. Actions like the undo gesture, for example, along with the ability to request the desktop version of a website in Safari rather than a mobile page, are all said to be getting improvements.
iPhone owners have grown used to getting yearly feature blasts, with new aesthetic and functional changes to their phones as Apple releases each free iOS update. In recent years, though, some of the features announced at WWDC, Apple’s annual developer event, haven’t arrived quite as rapidly as promised. Leaks out of the company last year suggested iOS 12 would be a more conservative release in terms of how many features were pre-announced, so as to avoid potentially embarrassing delays.
For 2023, though, Apple looks set to hit some well-requested features. Sources familiar with iOS 13 have shared some of the changes with 9to5Mac, and there are some gems among the updates.
Perhaps most exciting for some will be a new Dark Mode. That will be a system-wide setting, much as it is with macOS, that can be switched on for both iPhone and iPad. There’ll also be a new multitasking system, albeit only on iPad. Apps will be able to have multiple windows, it’s said, with different elements capable of being dragged out into an independent “card” that can be moved around, stacked, and flung away – webOS style, from the sound of it – to close them.
In Mail, there’ll be Gmail-style categorization of messages into different categories like shopping and promotional emails. A read-later queue will be added, too, it’s suggested. Easier selection of multiple items in lists has been introduced, and there’s a new undo gesture – a three-finger tap on the keyboard, with a swipe left triggering undo and a swipe right triggering redo – rather than the current shake-to-undo gesture.
Safari 13 will automatically load the desktop page of a website, at least on the iPad. “Hey Siri” is said to be gaining improved background noise rejection, and third-party productivity apps will apparently have more collaboration options. Some of the most welcome changes will be relatively minor: a new graphic for volume adjustment, for example, better in-app printing controls, and new UI tweaks for Split View apps.
For iPad owners in particular, iOS 13 is shaping up to be a big improvement. One of the persistent criticisms of the iPad Pro is that the software hasn’t held up to the hardware’s potential for replacing a laptop. After 2023’s focus primarily on iPhone features, it seems 2023’s iOS 13 will swing at least some of the attention back to iPad, and in a very welcome way.
If you’ve ever complained about how overloaded your phone is with apps to one of your friends, chances are, they are (or were) experiencing the same thing. This issue is not uncommon for smartphone users.
The causes of this phenomenon may vary. You may have downloaded every free game from the Apple App Store looking for something interesting to play. Or, you may have decided to try out all of the recommended apps from the store, only to realize that you barely use any of them.
No matter what the reason, it doesn’t take long before you realize there is little storage space left and your home screen is crowded with a lot of useless apps. Luckily, bulk removing apps from your iOS device is pretty straightforward. Plus, you don’t need to install any third-party service to do so.The “Normal” Way
Before going in, don’t worry about losing money when you remove an app that isn’t free. You can safely uninstall and reinstall paid apps since your payment data is attached to your Apple ID. However, keep in mind that in-app purchases (payments made inside the app for additional features) may or may not disappear.For iOS 12 and Older
In case you didn’t know, you can delete multiple apps from the comfort of your iPhone’s home screen.
First, tap and hold one of the app icons you want to delete—be careful not to press too hard to avoid triggering other gestures.
After one or two seconds, the apps should start jiggling, and an ‘X’ icon should appear on the top-left of every app on the home screen.
Tap on the X of any of the icons to delete the app. Do this for every app you want to remove.
Once you have finished erasing apps, press the Home button to go back to your normal view.For iOS 13+
Deleting multiple apps at once for iOS 13 and above users is a slightly different process. Holding the app icon will instead trigger a list menu to appear. Select Delete App to delete that particular application. Otherwise, choosing Edit Home Screen will let you delete multiple apps at once.
Once you pick Edit Home Screen, just like before, you will notice that every app in your home screen will have the ‘X’ icon appear beside it.
Tap the icon on any app that you wish to get rid of.
After you’re done, tap Done at the top-right of your screen.Use the Settings App
This time around, we will be using the Settings app. Going through Settings allows you to see the size of each individual apps. You can also view other useful information including the last time you used each of the apps and what type of app takes up most of your memory.
With that said, using Settings to remove apps is in no way more complicated than the previous method.
On the screen that appears, a list of your apps, as well as each app’s size, usage, and other info, should be displayed.
Choose any app that you want to remove and tap on Delete App.
Unfortunately, as of now, you can only delete apps one-by-one using Settings. Still, there is a way you can automatically ‘delete’ apps using the “offload” feature.Offload Feature
We put apostrophes around ‘delete’ to emphasize that offloading an app isn’t necessarily removing it. Instead, offloading preserves important documents and data generated by the app but throws away the rest. It’s different from deleting an app, where you remove all of the app’s data. When you reinstall an offloaded app, the saved data is brought back, unlike an actual deletion.
To activate the Offload feature, simply tap on Enable Offload Unused Apps from the same iPhone/iPad Storage window as before.
From a storage perspective, enabling offload is a must since apps that you haven’t used in a long time are automatically removed. Also, you might say that offloading an app is practically like deleting it. Data that is kept is often only in kilobytes, even if it’s for big files like games.
Some apps, however, like music players and photo editors, may store large files when offloaded. In this case, deleting them is more effective.Conclusion
In the past, Apple provided a more natural way to bulk remove apps at the same time using iTunes. For some reason, though, this feature was no longer available once iOS software upgraded to 12.7.
There are also a handful of third-party apps that you might prefer using, such as iMazing and iCareFone Cleaner. Even though you have to pay for these apps, both seem to be a decent replacement for the traditional iTunes method.
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