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Flourish Magnetic Device for Non-Surgical Treatment of Esophageal Atresia

Flourish Magnetic Device for Non-Surgical Treatment of Esophageal Atresia

The FDA is now allowing the introduction of Cook Medical‘s Flourish Pediatric Esophageal Atresia Anastomosis device as a non-surgical option for treatment of esophageal atresia, a birth defect in which the esophagus is not connected to the stomach due to a poorly formed esophagus. Two catheters with magnetic tips are positioned at the ends of the disconnected esophagus, one delivered transorally and the other via a gastric catheter through the stomach. The magnetic tips pull at each other and eventually push through the tissue to have the catheters meet each other. The child’s natural ability to heal allows this to happen within a couple weeks, and hopefully for the esophagus to develop normally. In a small study of the Flourish device, it successfully restored the esophageal lumen in all the infants, though most had to receive subsequent balloon dilation, stenting, or both. The Flourish device should not be used in patients older than one year, or who have teeth, which may damage the oral catheter. The device is also contraindicated in infants who have an existing tracheoesophageal fistula or who have esophageal segments that are more than 4 centimeters apart. Potential complications that may occur when the device is in place include ulceration or tissue irritation around the catheter implanted in the stomach and gum irritation due to pressure from the oral catheter. Potential long-term complications include gastroesophageal reflux. Link: FDA’s overview of Flourish… Via:...
The Digital Health Update by Paul Sonnier ⋅ May 18, 2017 ⋅ #275

The Digital Health Update by Paul Sonnier ⋅ May 18, 2017 ⋅ #275

I made this announcement to 55,997 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. Note that I will continue to update this announcement up until sending out the final version via LinkedIn. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here. The Digital Health Update by Paul Sonnier ⋅ May 18, 2017 ⋅ #275 Dear Group, I’ve published two issues of The Digital Health Newsletter since last week’s group announcement… The Digital Health Newsletter for May 13 Featuring: Marko Ahtisaari’s Sync Project is producing generative music as precision medicine and wellness; cyberattacks impact the NHS’s ability to deliver healthcare; new $500M in funding for Improbable’s massive virtual worlds to explore disease; Facebook serving as a ‘black market’ for life-saving drugs; Wearable Tech and AI is being used for understanding and prediction related to autism, heart attacks, and menstrual cycles; Guardant Health lands an additional $360M to continue its work in sequencing tumor DNA from more than 1 million cancer patients; a genetic locus is discovered that is associated with anorexia; and the Mediterranean diet can prevent the expression of inflammatory genes in tissues. Read the newsletter, here. The Digital Health Newsletter for May 16 Featured news includes for-profit dialysis companies, social media drug dealers, mass market glucose monitoring, enablement & assistance tech, brain-related research, genomics in medicine. Read the newsletter, here. I’ve copied and...
INSIGHTEC’s Exablate Neuro MR-Guided Focused Ultrasound Now Approved with 1.5T Scanners

INSIGHTEC’s Exablate Neuro MR-Guided Focused Ultrasound Now Approved with 1.5T Scanners

INSIGHTEC, maker of MR-guided focused ultrasound systems out of Israel, has received FDA approval to have its Exablate Neuro system alongside ‘s 1.5 Tesla MRI to be used for treatment of essential tremor in patients not sufficiently responding to drugs. Using MRI to image and target the ventral intermediate (VIM) thalamic nucleus in the brain, the system delivers focused ultrasound beams that ablate the tissue without haGE Healthcareving to open up the cranium. The 1.5 T indication is separate from the previously received 3.0T approval, and involves a different MR head coil. The importance of the new approval is that it allows hospitals with 1.5 T MRI machines, of which there are a lot more of than 3.0 T, to also offer MR-guided focused ultrasound procedures. Here’s a short video from INSIGHTEC about the workings of its technology: Flashback: Exablate Neuro MRI-Guided Focused Ultrasound for Essential Tremor Now Available in U.S… Product page: Exablate Neuro… Via:...
The Digital Health Update by Paul Sonnier ⋅ May 11, 2017 ⋅ #274

The Digital Health Update by Paul Sonnier ⋅ May 11, 2017 ⋅ #274

I made this announcement to 55,869 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. Note that I will continue to update this announcement up until sending out the final version via LinkedIn. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here. The Digital Health Update by Paul Sonnier ⋅ May 11, 2017 ⋅ #274 Dear Group, I’ve published two issues of The Digital Health Newsletter since last week’s group announcement… The Digital Health Update for May 6, 2017 Features news on the Republican plan to repeal Obamacare, which would mean everyone has a genetic- or digital data-predicted pre-existing condition that insurance companies can use to discriminate against you in terms of cost and denial of coverage, the CDC launches a ‘Healthy Behavior Data Challenge’, Pew Research Center Internet reports new data on the digital divide, Elon Musk’s SpaceX plans to bridge this divide with its planned global wireless Internet satellite service, augmented reality is being used by surgeons to project an overlay onto a patient during spinal surgery, plus more… Read the newsletter, here. The Digital Health Update for May 10, 2017 Features the following news: A startup transforming the $13 billion global dialysis market just received $76 million in funding, the Apple digital health juggernaut continues with a new acquisition, Chinese researchers take the top prize in a medical AI contest, a company...
Highlights from the Medical Alley Association’s 2017 Annual Meeting

Highlights from the Medical Alley Association’s 2017 Annual Meeting

The Medical Alley Association is a community of organizations that share the noble goal of promoting medical innovation and driving healthcare reform worldwide. More than 600 companies make up the Association, including giants like Medtronic, Mayo Clinic, 3M, and Abbott. The Association was founded in 1984 in Minnesota, a state with a long history of healthcare and medical innovation. Minnesota currently ranks as the number one Health Technology Cluster for innovation in the world. The Medical Alley Association held their annual meeting on April 27th at the Mall of America in Bloomington, MN. Hundreds of representatives from a wide variety of industries attended the annual meeting, demonstrating the great diversity of the Medical Alley Association. The purpose of the annual meeting was to thank the Association’s members, celebrate its accomplishments, and discuss current challenges. It also served as a great networking opportunity for the attendees. The meeting began with Shaye Mandle, President and CEO of the Medical Alley Association, highlighting the Medical Alley Association’s most recent accomplishments. He stated, “Over the past five years, our biotechnology and pharmaceutical community has grown by more than 1,000 jobs and added more than 1 million square feet of space [to that community’s businesses]. Our digital health companies have secured investments over the past five years that have increased by more than 540 percent, with nearly 1.4 billion dollars in exits. We are the number one state in healthcare performance and home to the United State’s number one hospital, Mayo Clinic…. 2016 saw a record number of Midwest healthcare companies attracting new equity investments. Minnesota ranked number one, attracting 424 million dollars.” Mandle...
GalaFORM 3D Scaffold FDA Cleared for Plastic, Reconstructive Surgeries

GalaFORM 3D Scaffold FDA Cleared for Plastic, Reconstructive Surgeries

Galatea Surgical, a division of Tepha, a company based in Lexington, Massachusetts, won FDA clearance for its GalaFORM 3D scaffold, a device designed for use during reconstructive and plastic surgery to support, lift, and reinforce soft tissues. The scaffold is made of a monofilament consisting of the naturally occuring poly-4-hydroxybutyrate (P4HB) enzyme. The material slowly disintegrates after implantation, eventually completely disappearing from the body in about 18 to 24 months, and being replaced by the patient’s own tissue. Moreover, it is hoped that being a monofilament will reduce the chance of infection. The GalaFORM 3D is indicated for “soft tissue support and to repair, elevate, and reinforce soft tissue where weakness or voids exist,” according to Galatea. It has a tough rim that helps to give strength to the device and therefore supporting the tissues surrounding it. The product is available in a variety of shapes and sizes to fit different patients and the anatomies being worked on. More about Galatea’s scaffold technology: Product page: GalaFORM 3D… Via:...
The Digital Health Update by Paul Sonnier ⋅ Apr 27, 2017 ⋅ #272

The Digital Health Update by Paul Sonnier ⋅ Apr 27, 2017 ⋅ #272

I made this announcement to 55,565 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. Note that I will continue to update this announcement up until sending out the final version via LinkedIn. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here. The Digital Health Update by Paul Sonnier ⋅ Apr 27, 2017 ⋅ #272 Dear Group, I sent out two of my Digital Health Update newsletters this past week. Below are highlights on what I featured. As previously mentioned, these go out first to subscribers of my free Constant Contact email newsletter, which you can subscribe to here. The Digital Health Update for April 25, 2017 Featuring my healthy chocolate recipe for genetically-disposed chocoholics (and everyone else!), healthcare jobs outpacing most other industries (and why establishment healthcare industry stakeholders have resisted and not pursued productivity and quality gains possible via digital health process improvements), a new Kaiser Permanente hospital here in San Diego, WHOOP for NFL players (who will own their data), a video demo of Qualcomm (medical) Tricorder XPRIZE-winning team Final Frontier Medical Devices for technology legend Steve Wozniak, the TODAY show’s review of apps to “help you get centered”, and an autonomous robot suitcase crowdfunding on Indiegogo. Read the newsletter, here. The Digital Health Update for April 22, 2017 Featuring a new AI-enabled chatbot for medical marijuana, telemedicine patients flashing their doctors...
The Digital Health Update by Paul Sonnier ⋅ Apr 6, 2017 ⋅ #269

The Digital Health Update by Paul Sonnier ⋅ Apr 6, 2017 ⋅ #269

I made this announcement to 55,135 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. Note that I will continue to update this announcement up until sending out the final version via LinkedIn. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here. The email newsletter version of this post “Are Medical Billing and Life Extension Efforts Part of Digital Health?” is viewable here. The Digital Health Update by Paul Sonnier ⋅ Apr 6, 2017 ⋅ #269 Dear Group, In breaking news for direct to consumer (DTC) genetic testing services, the FDA has given the green light to 23andMe to once again tell consumers if they have an increased risk of developing ten different diseases, including Alzheimer’s and Parkinson’s. In a statement, Dr. Jeffrey Shuren, the FDA’s director of the Center for Devices and Radiological Health, said that “Consumers can now have direct access to certain genetic risk information. But it is important that people understand that genetic risk is just one piece of the bigger puzzle—it does not mean they will or won’t ultimately develop a disease.” Two of the hallmarks of digital health are personalization (especially efficient scalability at the customer interface) and improved integration with the healthcare system. Increased quality, access to care, and improved patient outcomes are the sought after goals. I spoke with two startups this past week that epitomize these...
The Digital Health Update by Paul Sonnier ⋅ Mar 30, 2017 ⋅ #268

The Digital Health Update by Paul Sonnier ⋅ Mar 30, 2017 ⋅ #268

I made this announcement to 55,007 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here. The Digital Health Update by Paul Sonnier ⋅ Mar 30, 2017 ⋅ #268 Dear Group, After encountering a technical glitch with LinkedIn group announcements I have started using the Constant Contact (CC) email newsletter service to send out my weekly insights and news update. While group announcements are once again working, I have sent out two updates during this period. You’ll notice how much better the html text and images make the announcements look in the CC email format, which I’m really pleased with. I’ll still send group announcements, but you can subscribe to The Digital Health Update via the link below. Here are links to the two CC email newsletters plus I’ve copied and pasted the text from them below for better web-search (SEO) and archival purposes. Announcement #1: The Digital Health Update for March 25, 2017 — #266 Announcement #2: Are Medical Billing and Life Extension Efforts Part of Digital Health? The Digital Health Update for March 27, 2017 — #267 Subscribe to The Digital Health Update here I’m also excited to announce my new role as Contributing Editor at Innovation & Tech Today, a national magazine that showcases the latest cutting edge, innovative technologies, and those individuals driving...
The Digital Health Update by Paul Sonnier ⋅ Mar 27, 2017 ⋅ #267

The Digital Health Update by Paul Sonnier ⋅ Mar 27, 2017 ⋅ #267

Dear Group, The email newsletter version of this post “Are Medical Billing and Life Extension Efforts Part of Digital Health?” is viewable here. While we typically don’t think of medical billing as being a part of digital health, it is in fact mostly conducted using computers and is an integral part of the current U.S. healthcare system, ergo it’s digital health. And when it goes one step further, and actually empowers patients and providers to make vital healthcare decisions at the point of care, it’s even more significant in digital health terms. Backed by $25 million in funding, medical billing startup Eligible—founded by group member Katelyn Gleason—was featured in TechCrunch this past week. Can billions of dollars’ worth of high-tech research succeed in making death optional? That’s the question reporter Tad Friend asks in his New Yorker piece, “Silicon Valley’s Quest to Live Forever“. With genomics playing a big role in efforts like the National Academy of Medicine’s $25 million Aging & Longevity Grand Challenge, many life extension initiatives do fall within the realm of digital health. But as I’m often compelled to do, I disabuse people from the notion that life extension is a major goal of digital health. It’s certainly a potential outcome, but I feel it’s more important to focus on healthy living, quality of life, and improving healthcare as the main objectives of digital health. Trials have shown that artificial intelligence (AI) systems can outperform human medical experts in certain types of diagnosis. Writing in The New Yorker, Siddhartha Mukherjee takes an in-depth look at the state of the art: “The Algorithm Will See You...