Google, Varian partner on AI to boost cancer radiation therapy

Varian (NYSE: VAR) announced today that it is working with Google Cloud to build an AI-based diagnostic platform.

The companies’ focus is on AI models for organ segmentation—a crucial, labor-intensive step in radiation oncology that can often turn into a clinical workflow bottleneck. Organ segmentation can take hours per patient. It involves identifying the organs and tissues in diagnostic images that must be targeted or protected during radiation therapy.

Varian is using Google Cloud AI Platform’s Neural Architecture Search (NAS) technology to create an AI segmentation engine that it’s training — using Varian’s proprietary treatment planning image data — to create customized auto-segmentation models for organs in the body. Varian plans to incorporate the new models into its treatment planning software tools in cancer centers worldwide.

“At Varian, we are working towards a world without fear of cancer, where high-quality can…

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How can medtech companies use more patient input to improve clinical trials?

The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input.

Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on how to increase and utilize patient input to improve clinical trials in the medtech space.

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

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FDA advisory committee positive about TransMedics’ OCS Heart system

TransMedics (NSDQ:TMDX) this week said that the FDA Circulatory Systems Device Advisory Panel voted in favor of the OCS Heart System.

The FDA panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh the risks. The panel also voted 10 to 6, with 2 abstaining that there is reasonable assurance that the OCS Heart System is effective. It also voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System’s safety.

“This is a critical milestone for the OCS Heart technology on the path to a potential FDA approval, which I am confident would benefit patients in need of heart transplantation in the U.S. We are looking forward to working collaboratively with the FDA as it completes its review,” president and CEO Waleed Hassanein said in a news release. “We are grateful for the help and support of our investigators, the patients who enrolled in our trials, and the donor families who ga…

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Hologic to acquire Mobigiag in $795M deal

Hologic (NSDQ:HOLX) announced today that it entered into a definitive agreement to acquire diagnostic developer Mobidiag Oy for $795 million.

Finland/France-based Mobidiag develops and markets PCR-based tests for acute care conditions including gastrointestinal and respiratory infections, antimicrobial resistance management and healthcare-associated infections.

Mobidiag’s Amplidiag and Novodiag platforms are automated instruments that deliver rapid turnaround times ranging from 50 minutes to two hours, according to a news release. The Novodiag platform combines real-time PCR and microarray capabilities to provide multiplexing, allowing for multiple pathogens to be identified in a single sample.

Marlborough, Mass.-based Hologic is acquiring the company for an enterprise value of approximately $795 million, which includes a cash payment of approximately $714 million for Mobidiag’s equity and net debt of approximately $81 million.

“One of…

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Dräger acquires majority share of Stimit and its tech to help people breathe

Dräger recently announced that it has acquired a majority stake in Swiss medtech startup Stimit and its noninvasive tech to stimulate intensive care patients’ respiratory muscles.

The financial terms of the deal were not disclosed in the April 1 announcement. Stimit will work with Dräger in the following months to further develop the product and conduct clinical trials.

The spotlight has been on mechanical ventilation over the past year amid the COVID-19 pandemic and the respiratory distress in severe cases of the disease. The respiratory muscles and diaphragm can weaken after just a few days of ventilation. Stimit’s technology helps maintain and build up the diaphragm through electromagnetic field stimulation.

“With Dräger at our side, we will create clinical evidence to establish a novel therapy to serve patients,” Stimit CEO Ronja Müller-Bruhn said in a news release.

Dräger executive Stephan Kruse said Stimit is working on a concept…

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Sandia Labs seeks partners to make reusable masks

Sandia National Laboratories engineer Todd Barrick models a prototype of the reusable respirator he and 16 colleagues developed to complement disposable N95 masks. (Photo by Randy Montoya)

Sandia National Laboratories has come up with its own version of a reusable respirator for frontline workers.

Sandia has filed for patent protection, is testing prototypes, and seeking NIOSH approval and potential manufacturing partners for its elastomeric half-mask N95 respirator. It’s the latest entry to a small but growing category of reusable masks designed to filter at least 95% of airborne virus particles from being inhaled and exhaled.

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

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Abbott wins CE mark for next-generation TriClip

Abbott (NYSE:ABT) announced today that it received CE mark approval for its next-generation TriClip transcatheter tricuspid valve repair system.

The company touts the TriClip as a first-of-its-kind, minimally invasive tricuspid heart valve repair device for treating tricuspid regurgitation (TR), according to a news release.

Abbott Park, Ill.-based Abbott’s clip-based therapy is a non-surgical heart valve repair option specifically designed for treating TR by allowing physicians to tailor repair of the valve to each patient’s unique anatomy. When unaddressed, TR can lead to Afib, heart failure and potentially death.

TriClip was specifically designed to treat the complex anatomy of the tricuspid valve, offering precise and stable delivery engineered for navigating the right side of the heart.

In the Triluinate CE mark study, TriClip demonstrated sustained symptomatic improvement, reduction in the severity of TR and improvement in functio…

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MedShape appoints chief medical officer

MedShape this week announced that it has appointed Greg Berlet as chief medical officer.

Berlet will be responsible for new clinically-focused initiatives to advance the knowledge and use of active, adaptive healing approaches for orthopedic surgeons to improve patient outcomes.

“MedShape is changing the paradigm for how fusion is addressed in foot & ankle orthopedics with the company’s products demonstrating clinical success across various challenging patient populations,” Berlet said in a news release. “I look forward to working with the MedShape team to deliver novel dynamic fusion solutions to more patients and to develop a better understanding on how dynamic fixation impacts the healing process.”

Berlet has more than 22 years of experience as a foot and ankle fellowship-trained orthopedic surgeon and is a founding partner of the Orthopedic Foot and Ankle Center in Columbus, Ohio.

“We are pleased to form…

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TriSalus, University of Texas to collaborate on solid tumor treatment study

TriSalus Life Sciences and the University of Texas today announced a collaboration to evaluate the treatment of solid tumors.

The Texas MD Anderson Cancer Center and TriSalus will collaborate on treatments for tumors of the pancreas and liver by integrating interventional delivery of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in combination with checkpoint inhibition immunotherapy, according to a news release.

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

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Teva Pharmaceuticals receives European approval for Spiromax inhalers

Teva Pharmaceuticals announced today that it received European marketing authorization for its Seffalair and BroPair Spiromax inhalers.

Seffalair Spiromax and its duplicate BroPair Spiromax (salmeterol xinafoate/ fluticasone propionate, 12.75/100 and 12.75/202 micrograms delivered doses) received approval as a maintenance treatment for asthma in adults and adolescents aged 12 years and older, according to a news release.

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

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ABC debuts drama about evil medtech company

Tamala Jones (left) and Katey Sagal in Rebel (Image courtesy of ABC)

ABC-TV will this week begin airing “Rebel,” an Erin Brockovich-inspired drama in which the main character investigates a fictional medtech company.

Stonemore Medical manufactures heart valves that cause autoimmune problems in 3,000 patients, according to ABC.

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

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Medtronic commits to helping people of color with diabetes

Medtronic (NYSE:MDT) announced today that it entered multiple partnerships to help improve health equity for people of color living with diabetes.

Fridley, Minn.-based Medtronic committed investments in partnerships with the American Diabetes Association (ADA) and the T1D Exchange, along with additional research efforts, to better understand and address such disparities, according to a news release.

The company is providing a $1 million sponsorship over the next three years to ADA’s Technology Access Project (TAP) which sets out to provide access and availability of diabetes technology regardless of gender, race, income or location.

“Health equity in diabetes is central to our mission, and unfortunately, for many the latest technological advancements to support living with the disease are not accessible due to insurance barriers and high out-of-pocket costs,” ADA chief development officer Charles D. Henderson said in the release. “…

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