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This ‘e-tattoo’ could provide early detection for heart disease

The e-tattoo for monitoring heart health [Image courtesy of the University of Texas]

Researchers at the University of Texas developed a new flexible, wearable “electronic tattoo” for heart monitoring.

The ultrathin, lightweight “e-tattoo” attaches to the chest for continuous, mobile heart monitoring outside of a clinical setting. It features two sensors that combine to provide a clear picture of heart health. Researchers developed it in an effort to give clinicians a better chance to catch early red flags for heart disease.

The Texas team published their study in Advanced Electronic Materials.

“Most heart conditions are not very obvious. The damage is being done in the background and we don’t even know it,” Nanshu Lu, a professor in the Department of Aerospace and Engineering Mechanics and a lead author of the study, said in a post on the UT website. “If we can have continu…

NeuroOne launches Evo sEEG electrodes in the U.S.

The Evo sEEG [Photo courtesy of NeuroOne]NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it commercially launched its Evo sEEG electrode line in the U.S.

Zimmer Biomet holds exclusive worldwide distribution rights to the Evo Cortical and sEEG product lines. NeuroOne expects the line to utilize Zimmer Biomet’s Rosa One Brain robotic surgery platform for neurosurgical procedures. Zimmer paid $3.5 million to NeuroOne under the deal in August 2022. That came after an up-front payment of $2 million in 2020. NeuroOne began shipping commercial orders in the deal in November 2022.

“The commercial launch of the Evo sEEG platform represents one of the most impactful milestones in our company’s history,” said NeuroOne CEO Dave Rosa. “Paired with Zimmer Biomet’s ROSA One Brain robotic platform and broad distribution network, we believe the Company is well positioned in the market given the synergies that exist between our novel thin film ele…

Is medtech the answer to healthcare challenges?

[Image from Unsplash]The aftermath of the COVID-19 pandemic has healthcare in the U.S. and elsewhere facing a host of challenges, but medtech could be part of the answer.

Join industry leaders at DeviceTalks Boston, May 10–11, 2023, to find out more about the opportunities. (Register here!)

Here are some of the topics to explore at the event:

Healthcare challenges: Worker shortages

Hospitals and other healthcare settings are facing shortages of physicians, nurses and other critical staff — but one of many healthcare challenges.

BD CEO, President and Chair Tom Polen [Photo courtesy of BD]Opportunity: In a keynote interview, Becton Dickinson CEO Tom Polen will lay out a plan for growth building off a sequence of acquisitions over the past two years that has the company loaded with tech — including digital and robotics tools. In a DeviceTalks Weekly interview, Polen saw automation of pharmacies and lab testing as a sizable growth opportunity for BD.

How to plan decentralized clinical trials

[Image from Unsplash]

Decentralized clinical trials offer a wide range of benefits for medical device makers and the patients they serve.

With that in mind, the FDA has released draft guidance for decentralized clinical trials to advance medical product development and research.

Decentralized clinical trials use locations other than traditional clinical trial sites for some or all of the trial-related activities. That means patients who might have previously needed to travel to research sites — their doctor’s office, for example, or a university hospital — can instead participate in trials at home or closer to home.

This allows a broader, more diverse representation of the population to take part in experimental medicine, helping to reduce gender, racial or socioeconomic inequality in medical care.

“The FDA has long considered the benefits of decentralized clinical trials. Advan…

Arsenal rebrands advanced automation platform as Invio

NEWS RELEASE: Arsenal’s Automation Solutions Platform Rebranded as Invio Automation

Arsenal Capital Partners (“Arsenal”), a leading private equity firm that specializes in investments in industrial growth and healthcare companies, today announced the rebranding of its advanced automation solutions platform to Invio Automation (“Invio”).

Formed through a combination of Eckhart, Inc. and Innovative Products & Equipment, Inc., Invio Automation provides high-value solutions to help customers accelerate growth in specialized markets including medical device, life sciences, and advanced manufacturing.

With its scaled engineering resources and end-to-end expertise in complex automation, the company aims to serve a targeted portfolio of growth markets supported by recognized and sustainable macro tailwinds. Invio works closely with innovative companies to design, build, implement, and maintain automation solutions in high-precision…

CorVent Medical appoints Jeremy Nelson as COO

Jeremy Nelson. [Image courtesy of CorVent Medical]CorVent Medical announced today that it appointed Jeremy Nelson as its new chief operating officer (COO).

Fargo, North Dakota-based CorVent says Nelson brings nearly 20 years of operational experience to the role. His expertise comes across supply chain, manufacturing, engineering and automation. He will be based at CorVent’s Fargo office.

“We are excited to add Jeremy to our outstanding executive team at CorVent. Jeremy’s proven expertise in operations, supply chain and quality will be instrumental as we build and expand operations in Fargo North Dakota–transitioning from a startup to a commercial medical device company,” said Richard Walsh, CorVent Medical CEO.

Walsh called Nelson “a key asset” as the company moves into its new 15,000-square-foot headquarters.

Nelson joins CorVent having collected experience at Smith+Nephew, Ethicon Endo-Surgery and Zimmer Biomet.…

Concept Medical wins FDA IDE approval to investigate MagicTouch sirolimus coated balloon catheter

Concept Medical this week announced that the FDA has granted an investigational device exemption (IDE) approval for its MagicTouch sirolimus-coated balloon (SCB).

The IDE approval covers the device for treating small vessels in coronary arteries. It was the third IDE approval for the company’s MagicTouch SCB. The IDE approval will allow Concept Medical to initiate a pivotal clinical study to support the safety and effectiveness of the device in small vessel coronary disease.

Along with the IDE approval for treating small vessels, Concept Medical also received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary in-stent restenosis indication and below-the-knee indication.

“The FDA-approval to initiate the MAGICAL-SV Clinical trial using the MagicTouch sirolimus-covered balloon with novel coating technology represents a landmark event in our decades-long quest to find an optimal therapy to manage pati…

3M layoffs include 1,100 at its Minnesota HQ campus

3M (NYSE: MMM) + notified the state of Minnesota of its plans to lay off approximately 1,100 employees connected to its headquarters.

News of these specific layoffs come hand-in-hand with last month’s announcement that 3M planned to reduce its headcount by 6,000 employees. That followed a previous announcement of 2,500 layoffs in January.

It remains unclear how many of the job cuts come from the 3M’s Health Care business, which remains on track for a spin-off. The total 8,500 jobs getting cut represent nearly a tenth of the manufacturing giant’s global workforce. 3M expects the restructuring initiative to save the company $700–900 million a year before taxes.

The cost-reduction plans include reducing the size of the company’s corporate center, simplifying the supply chain, streamlining the company’s geographic footprint and reducing management layers. 3M also plans to streamline its go-to-market mode…

Zimmer Biomet’s profits were 16 times greater in Q1

Zimmer Biomet (NYSE: ZBH) + saw its stock rise today on Street-beating first-quarter results and raised guidance that analysts described as impressive.

ZBH shares were up more than 3% to $143.68 by late morning. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up slightly.

News of the strong Q1 comes a day after Zimmer Biomet announced its latest acquisition — Ossis, a maker of personalized 3D-printed implants.

ZB’s results should add to the case that this could be a boom year for the orthopedic device market. The space is benefitting from a bounce-back of procedures as the COVID-19 situation normalizes.

BTIG analysts’ note had the headline, “Orthopedics is having its moment, and ZBH is benefiting.” Along with the backlog of patients, there are easy comps and multiple technologies that provide faster recovery, according to …

Dexcom proposes $1B offering of convertible senior notes

Dexcom (Nasdaq:DXCM) today announced that it intends to offer $1 billion in convertible senior notes due in 2028.

The continuous glucose monitor (CGM) maker made its private placement to persons reasonably considered qualified institutional buyers. San Diego-based Dexcom also plans to grant the initial purchasers of the notes an option to buy more. Those options fall within a 13-day period from, and including, the date of first issuance, for up to an additional $150 million.

Dexcom said in a news release that its notes are senior, unsecured obligations with interest payable semi-annually in arrears. The notes mature on May 15, 2028, unless earlier converted, repurchased or redeemed.

Dexcom earmarked a portion of its net proceeds to pay the cost of capped call transactions. If the initial purchasers exercise their option to buy additional notes, the company intends to use a portion of those proceeds to enter into additional capped call transactions.

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Teleflex launches two new PICC insertion devices

Teleflex (NYSE:TFX) + today announced it launched two new devices to enhance PICC insertion procedures and reduce complications.

The company launched the Arrow VPS Rhythm DLX device and the NaviCurve stylet, both of which Teleflex designed to work together to give vascular access specialists more efficient and predictable PICC placement.

VPS Rhythm DLX gives physicians real-time catheter tip location information using the patient’s cardiac electrical activity. The device is available with an optional integrated ultrasound featuring a catheter-to-vessel ratio tool that promotes standardization in vessel measurement. It can work with the Arrow PICC preloaded with the NaviCurve stylet for tip navigation/location technologies.

According to the company, VPS Rhythm DLX with TipTracker technology eliminates the need for a confirmatory x-ray and helps clinicians insert seamlessly through ultrasound vessel assessme…

Surmodics enrolls first patient in Pounce thrombectomy system registry study

Surmodics recently announced it enrolled the first patient in its Prowl registry study of its Pounce thrombectomy system.

Prowl is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry aims to collect real-world efficacy and safety outcomes data for endovascular interventions. It will enroll up to 500 patients at up to 30 sites.

The first site to enroll a patient in the registry study was Baton Rouge General Medical Center in Baton Rouge, Louisiana. Dr. Sean Lyden, chairperson of the department of vascular surgery at the Cleveland Clinic, and Dr. Joseph Campbell, interventional cardiologist at OhioHealth, are national co-principal investigators.

“We are delighted to be the first site to enroll a patient in the Prowl registry,” Dr. Joseph Griffin, a vascular surgeon at the Vascular Specialty Center and Baton Rouge Gene…