How Mayo Clinic will accelerate Endiatx’s PillBot development

Endiatx co-founder and CEO Torrey Smith with PillBot [Photo by Hardy Wilson for MDO]

After months of negotiations, Endiatx and Mayo Clinic have reached a deal that will accelerate the development of Endiatx’s PillBot robotic stomach camera.

The know-how licensing agreement gives Mayo Clinic a small but significant equity stake in the medical device startup, Endiatx co-founder and CEO Torrey Smith told Medical Design & Outsourcing.

“We were proud to give some equity to Mayo Clinic, and it means that we can co-develop this technology,” Smith said in an interview. “We’re not having them develop intellectual property, but what we are doing is having them coach us clinically. Basically, this is a chance to make sure that the tech that we are developing is exactly what gastroenterologists actually need.”

Dr. V…

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What’s so special about Apollo Endosurgery’s stomach-shrinking weight loss tech?

The Apollo Endosurgery OverStitch Sx endoscopic suturing system [Image courtesy of Apollo Endosurgery]

Apollo Endosurgery — set to be purchased by Boston Scientific for $615 million — develops new devices and minimally invasive procedures for weight loss.

The procedure is called endoscopic sleeve gastroplasty (ESG) and the device that made it possible is the OverStitch endoscopic suturing system.

Austin, Texas-based Apollo Endosurgery first won 510(k) clearance for OverStitch in 2008, with successive clearances for improved designs over the years. Most recently, in July the FDA granted de novo clearance for Apollo Endosurgery’s Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx systems. They’re the first FDA-authorized devices for ESG and endoscopic bariatric revision procedures.

Medical Design & Outsourcing spoke with Apollo Endosurgery Chief Medical Officer Dr. Christo…

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How NeuroOne and Zimmer Biomet will partner on robotic brain surgery

The NeuroOne Evo sEEG [Photo courtesy of NeuroOne]

NeuroOne is preparing its depth electrode technology for commercialization through Zimmer Biomet (NYSE: ZBH) while waiting for FDA feedback on its latest submission.

NeuroOne’s Evo stereoelectroencephalography (sEEG) device won FDA 510(k) clearance in September 2021 for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

That clearance was for temporary use (less than 24 hours), and NeuroOne applied in November to extend the duration of use to less than 30 days. The FDA denied that application in May, but said the company could try again with new subacute toxicity biocompatibility evidence.

NeuroOne CEO Dave Rosa [Photo courtesy of NeuroOne]

“We ran into a methodology issue or disagreement with them on the last test that we performe…
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Mayo Clinic develops AI childbirth risk prediction tool for women in labor

Dr. Abimbola Famuyide is a Mayo Clinic OB-GYN studying AI algorithms for childbirth. [Photo courtesy of Mayo Clinic]

Mayo Clinic researchers are using AI algorithms to calculate childbirth risk while women are in labor in an effort to reduce the rate of cesarean delivery and complications.

The machine learning algorithms — a type of device known as Software as a Medical Device (SaMD), where the software is the device rather than a mechanical device — analyze patterns of changes for women in labor.

ADVICE: How to pass the patent eligibility test for Software as a Medical Device

“This is the first step to using algorithms in providing powerful guidance to physicians and midwives as they make critical decisions during the labor process,” senior author Dr. Abimbola Famuyide said in a news release. “Once validated with further research, we believe the algorithm will work in real time,…

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New method of cardiac ablation used in first in-human trial for ventricular tachycardia

Thermedical’s Durablate catheter [Photo courtesy of Thermedical]

A new cardiac ablation technique for patients with ventricular tachycardia (VT) has been used in its first in-human multicenter trial involving Mayo Clinic.

The new process — needle ablation using in-catheter, heated, saline-enhanced, radio frequency (SERF) energy — creates lesion scars inside the heart muscle where life-threatening arrhythmias cause VT, Mayo Clinic said. Injecting heated saline at the same time as the RF energy is applied increases heat transfer compared to conventional methods of ablation, which means the ablation can treat tissue deeper in the heart wall than the surface.

Caused by irregular electrical signals in the lower chambers of the heart, VT can trigger heartbeats so rapid that the heart’s chambers don’t fill with blood properly. VT can also stop the heart entirely. Implantable cardioverter-defib…

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MIT engineers develop wearable, stamp-sized ultrasound stickers for continuous imaging

MIT engineers have developed a postage-stamp-sized, wearable ultrasound device. [Photo courtesy of MIT]

A team of MIT engineers is working to make getting an ultrasound as simple as buying a book of stamps.

They’ve developed a postage-stamp-sized ultrasound device that can be stuck to the skin and worn for continuous imaging of internal organs over 48 hours.

Once the engineers work out wireless connectivity, the ultrasound stickers could be worn by patients at home or on the go, even during exercises like jogging, biking and lifting weights, they said as they presented their work in Science. The ultrasound stickers could be used to monitor internal organs, tumor progression, fetal development or even the point of a workout regimen where further exertion will lead to muscle overuse and soreness.

“We envision a few patches adhered to different locations on the body, and the patches would commu…

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Making biomedical data computable

Vik Nagjee is the vice president of product at nference [Photo courtesy of nference]

Cloud computing can power quantum leaps in human health.

Vik Nagjee, nference

A state-of-the art platform that supports real world evidence (RWE) and health economics and outcomes research can enable breakthroughs at an unprecedented scale.

This is achieved by making the de-identified, transformed information contained within the electronic medical record (EMR) available for data science and analysis at the aggregate and patient level. Add multi-modal data sources such as imaging and electrocardiograms as well as novel data assets like digital pathology and omics data to enrich the EMR data to provide a truly longitudinal view of the patient, and you have the beginnings of a world-class platform.

The keys are privacy preservation, harnessing longitudinal data, data enrichment and a data science platform.

P…
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Endiatx’s pill-sized robot sees and swims inside the stomach

Endiatx co-founder and CEO Torrey Smith with PillBot [Photo by Hardy Wilson for MDO]

An unconventional CEO and his team take aim at endoscopies with faster, cheaper stomach imaging — and that’s just the start. Welcome to the era of tiny robots inside the body.

As he prepared to swallow his robot for the first time, Torrey Smith’s doctors warned that the battery was his greatest threat.

If the capsule came apart and the battery burned the tissue lining his stomach, it would only be the beginning of a very bad experience.

“I was just hoping that we would get any kind of a positive signal that we were on the right track,” Smith, co-founder and CEO of Endiatx, said of the June 2020 test. “At that time, our radio bandwidth was so limited. We were pushing 48 pixels square of grayscale, not even color, at just a few frames per second. The worst video quality you could imagine —…

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Deadline nears for gBETA Medtech startup accelerator

The gBETA program for medtech startups is seeking applicants from across the globe on or before March 14 for its spring session.

The seven-week gBETA Medtech virtual accelerator runs April 18 through June 14. gBETA is a program of startup accelerator Gener8tor and the University Enterprise Labs business incubator in St. Paul, Minnesota, with support from Mayo Clinic, the University of Minnesota, Medical Alley Association and founding sponsor Boston Scientific.

Up to five startups will be selected for the medtech program, which covers medical devices, diagnostics, healthcare software, biotechnology, drug discovery and delivery and more. They’ll participate in webinars, regular meetings with the gBETA Medtech team, mentor and investor swarms — like speed dating sessions with founders, investors, serial entrepreneurs, technical professionals, board members and industry experts — and then a demo day and pitch night, followed by ongoing support after the progr…

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What is microscale 3D printing? Lessons learned from Mayo Clinic

These 3D printed microneedles — viewed through a scanning electron microscope — are pictured next to a traditional 29-gauge hypodermic needle. A human hair is approximately as wide as the 100 micron scale marker in the image. [Image courtesy of Mayo Clinic]

Microscale 3D printing has the potential to revolutionize medical device development.

Seth Hara, Ph.D., and Renc Saracaydin, Mayo Clinic

The Mayo Clinic Division of Engineering is an embedded engineering team that provides engineering support and service for researchers and clinicians throughout the enterprise. To meet their needs, the engineering team has embraced the use of microscale 3D printing.

Microscale 3D printing in medical device development is still relatively new. As this technology continues to mature, the field will continue to find new and exciting opportunities to advance the practice of medicine.

As the name implies, micros…

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NaNotics to work with Mayo on nanomedicine cancer therapy

NaNotics LLC (Mill Valley, California) has announced that it will work with the Mayo Clinic to develop a cancer treatment known as NaNots that works by depleting targeted pathogenic molecules from the blood. The NaNot would target a soluble form of programmed death-ligand 1 (PD-L1), a tumor-generated immune inhibitor, while ignoring membrane forms of PD-L1.

“Our team has been studying sPD-L1 for several years,” said Dr. Sean Park, an oncologist at Mayo Clinic, in a statement. “We believe it’s a key driver of immune evasion for many tumor types.”

Park said the ability to home in on soluble PD-L1 is “potentially significant.”

“We’re excited to collaborate with NaNotics and test NaNots against sPD-L1 in humans for the first time,” he added.

NaNot image courtesy of NaNotics

NaNotics hopes to file an investigational new drug (IND) application with the FDA to begin human clinical trials within…

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Mayo Clinic expands plans for new research lab in Minnesota

A rendering of the Anna-Maria and Stephen Kellen Building. [Image courtesy of Mayo Clinic]

The Mayo Clinic is roughly tripling the size of the new research lab it plans to build in its home city of Rochester, Minn.

Before the COVID-19 hit, plans called for a four-story building. But officials at the top-tier health provider say the pandemic taught them that scientific advancements need to accelerate in healthcare. The Anna-Maria and Stephen Kellen Building will now be 11 stories and 176,000  ft2 upon its completion, scheduled for the fourth quarter of 2023.

Get the full story on our sister site Medical Design & Outsourcing. 

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