MassDevice Archives - Page 326 of 587 - Medical Design Sourcing

Medtronic performs first procedure with Hugo surgical robot in Europe

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that it performed the first clinical procedure in Europe with its Hugo robotic-assisted surgery system.

Dr. Alexandre Mottrie, head of urology at OLV Hospital in Aalst, Belgium, and CEO and founder of the Belgium-based ORSI Academy for training, R&D and data analysis for improving minimally invasive surgery best practices, performed the robotic prostatectomy. Hugo received CE mark approval for urologic and gynecologic procedures in October 2021.

Read: President of Medtronic’s surgical robotics business Megan Rosengarten shares the company’s excitement as Hugo clears European regulatory milestone.

“Performing Europe’s very first procedure with the Hugo RAS system is a career highlight for me,” Mottrie said in a news release. “With more than two decades and 4,000 robotic-assisted surgery procedures under my belt, I am intimately aware of the barriers that have kept th…

BD board approves embecta diabetes business spinoff

BD (NYSE:BDX) announced today that its board of directors approved the planed spinoff of its diabetes care business, embecta.

Franklin Lakes, N.J.-based BD confirmed in May 2021 that it planned to spin off its diabetes care business as an independent, publicly-traded company during the first half of 2022 and in December 2021 it confirmed the naming of the new business as “embecta” (Embecta Corp.).

Get the full story at our sister site, Drug Delivery Business News.

Globus Medical accuses Medtronic and former sales employees of stealing business

Globus Medical (NYSE:GMED) has accused four former sales employees of wrongfully joining Medtronic (NYSE:MDT) and taking business with them, saying in a lawsuit that Medtronic knew what was happening.

Audubon, Pennsylvania-based Globus filed the lawsuit on Jan. 28 in Pennsylvania’s Eastern U.S. District Court against Medtronic, three former Globus spine territory managers and one former associate spine specialist.

Fridley, Minnesota-based Medtronic has not yet responded to the lawsuit in court, but offered a statement to Medical Design & Outsourcing today.

“The company believes its conduct has been proper and will defend itself vigorously against these claims,” Medtronic said in the statement. “Medtronic remains committed to fair competition and employment practices that comply with the law and enable the company to attract and retain a best-in-class, highly talented and innovative workforce dedicated to improving lives through medical technology.” Read more

FDA clears VySpine’s interbody fusion system

[Image from VySpine]VySpine announced today that it received FDA 510(k) clearance for its ClariVy cervical interbody fusion (IBF) system.

Tallahassee, Florida-based VySpine designed its ClariVy cervical IBF system for use in anterior cervical discectomy with fusion (ACDF) procedures.

According to a news release, the ClariVy system includes cervical interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced. The former has been the standard for interbody devices for decades with radiolucency and a modulus of elasticity close to that of natural bone, while the latter has embedded hydroxyapatite fibers to create a better bony apposition to the implant, the company said.

VySpine offers the ClariVy system in a range of 4mm to 11mm and either with or without locking screws. They are also available in a range of lordosis and feature IBF-S implants, which have self-drilling screws to aid in anchoring the device directly to the bone.

MassMEDIC announces board additions

The Massachusetts Medical Device Industry Council (MassMEDIC) today announced the appointment of eight new members to its board of directors.

Joseph Ferrara, Michelle Fox, Brent Fullerton, Chris Killburn-Peterson, Jaydeo Kinikar, Sonal Patel, Stacey Pugh and Adam Sachs have all joined the MassMEDIC board.

“We are honored to welcome our new members to our Board of Directors to further the mission of saving and improving the lives of patients everywhere through medical technology,” MassMEDIC President Brian Johnson said in a news release. “Their dedication to continuous improvement of our healthcare ecosystem in Massachusetts and New England, paired with their industry expertise, will strengthen our community built on collaboration and collaborative success.”

Ferrara serves as chief innovation officer at Veranex and holds more than 25 years of experience in the medtech industry. Fox, who is CMO at Teleflex, offers vast experience in clinical affairs and…

Surgical robotic developer leads device makers in top healthcare VC deals

CMR Surgical’s Versius system console [Photo courtesy CMR Surgical]Surgical robotics developer CMR Surgical was the lone medical device maker in the 10 largest healthcare venture capital deals of 2021 in the U.S. and Europe.

That’s according to a ranking provided to Medical Design & Outsourcing by Silicon Valley Bank (SVB), which recently published its annual VC analysis drawing on its own proprietary information and data from Pitchbook.

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

Cardinal Health to pay $13M to settle claims it paid kickbacks to doctors

The U.S. Justice Dept. (DOJ) announced that Cardinal Health (NYSE:CAH) agreed to pay more than $13 million to resolve kickback allegations.

Allegations against Dublin, Ohio-based include a violation of the False Claims Act by paying “upfront discounts” to its physician practice customers in violation of the Anti-Kickback Statute.

Get the full story at our sister site, Pharmaceutical Processing World.

Study bolsters case that vaccines protect against long-COVID

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML.

It may be too soon to know how often the omicron variant is associated with so-called long-COVID, but research from the Leavitt Partners’ COVID-19 Patient Recovery Alliance confirms that vaccination protects against the condition.

Those who received at least one authorized COVID-19 vaccine dose before diagnosis were between seven and 10 times less likely to report two or more long-COVID-19 symptoms, according to the preprint study conducted before the surge of the delta variant.

Those who received a vaccine four weeks after diagnosis were four to six times less likely to develop the condition.

Get the full story from our sister site, Drug Discovery & Development.

Fractyl Health touts 2-year durability study for diabetes reversal procedure

Fractyl Health today announced that it published two-year durability data from its Revita-1 clinical study in Europe and South America.

Lexington, Massachusetts-based Fractyl’s trial included two-year follow-up from 34 type 2 diabetes patients who received the company’s Revita duodenal mucosal resurfacing (DMR) procedure.

Get the full story at our sister site, Drug Delivery Business News.

FDA clears AliveCor’s next-generation credit card-sized ECG device

[Image from AliveCor]AliveCor announced today that it received FDA clearance for and launched its next-generation KardiaMobile electrocardiogram (ECG) device.

Mountain View, California-based AliveCor touts the KardiaMobile Card as the slimmest, most convenient personal ECG device ever made, designed at the size of a standard credit card, fitting into wallets and providing a medical-grade, single-lead ECG in 30 seconds.

According to a news release, AliveCor’s KardiaMobile Card represents the first credit-card-sized ECG to garner FDA clearance.

“After disrupting traditional ECG monitoring with our game-changing Kardia platform, we have now achieved the unprecedented milestone of creating the first-ever credit-card-sized personal ECG,” AliveCor CEO Priya Abani said in the release. “KardiaMobile Card delivers the most sophisticated AI in the most convenient form factor ever, putting the power of real-time ECG analysis directly in patient…

Butterfly Network partners with Ambra Health on cloud-based ultrasound data integration

Butterfly Network (NYSE:BFLY) announced today that it partnered with Ambra Health (an Intelerad company) to improve interoperability for bedside imaging data.

The partnership aims to accelerate and simplify bedside imaging data interoperability by strengthening the scalability of Butterfly’s Blueprint enterprise platform and enhancing access to and shareability of valuable ultrasound information across hospitals and health systems.

Guilford, Connecticut-based Butterfly said in a news release that it plans to utilize Ambra’s background in bringing disparate imaging information together in a streamlined, efficient manner across large health systems. Together, the companies intend to unlock real-time information and drive better clinical decision-making through enhanced online data integration for ultrasound information.

“Our partnership with Ambra Health furthers our goal for Butterfly to become a foundational platform to leading healthcare ins…

BD acquires blood disease detection tech developer Cytognos

BD (NYSE:BDX) announced today that it completed the acquisition of flow cytometry solution developer Cytognos.

Salamanca, Spain-based Cytognos specializes in flow cytometry solutions for blood cancer diagnosis, minimal residual disease (MRD) detection and immune monitoring research for blood diseases.

Franklin Lakes, New Jersey-based BD said in a news release that the acquisition accelerates its strategy to support chronic disease management by expanding its portfolio of blood cancer diagnostics, immune assessment tests and informatics to better understand the immune system, immune response and MRD.

The company said monitoring for MRD offers lab managers and physicians a way to detect low levels of cancer cells after treatment to demonstrate if the disease is still present or if there is a signal of recurrence.

“As the understanding and treatment of cancer evolves and improves, the importance of monitoring post remission cancer survivors has…