FDA clears new radiotherapy systems from Siemens Healthineers’ Varian

The TrueBeam imaging system now has FDA clearance with HyperSight technology. [Image from Varian]Varian announced today that it received FDA 510(k) clearance for its TrueBeam and Edge radiotherapy systems with HyperSight imaging.

The Siemens Healthineers company designed HyperSight to empower clinicians to accurately tailor treatments to individual patients. This helps improve patient outcomes, thanks to new capabilities and workflows across the company’s linear accelerators.

HyperSight allows clinicians to acquire high-quality images during a patient’s daily course of radiation treatments. It helps to improve the ability to target tumor volumes more precisely and spare healthy tissue for patients undergoing radiation therapy.

Adding HyperSight to the Varian line of linear accelerators means the company’s portfolio can produce images that deliver the Hounsfield Unit (HU) accuracy necessary for treatment planning directly on the acquired co…

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Siemens Healthineers’ Varian acquires oncology solutions company Aspekt Solutions

Varian, a Siemens Healthineers company, announced today that it acquired oncology solutions provider Aspekt Solutions.

Aspekt Solutions provides medical physics, dosimetry and strategy consultation services. The acquisition aims to expand Varian’s advanced oncology solutions (AOS) offerings. Palo Alto, California-based Varian wants to increase the ability to address the rising demand for customized services and standardized care.

Varian provides support for every step of the chance care journey, from screening to survivorship. Its offerings include imaging and radiation therapy, plus software and services and interventional radiology.

Through AOS, Varian offers tailored engagements harnessing technology and combining it with professional support. These support teams collaborate with cancer centers to realize their unique goals. The company says it helps them expand, upgrade or standardize operations while implementing global best practices in cance…

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Varian wins U.S., European clearance for radiotherapy systems

The Halcyon radiotherapy system. [Image from the Varian website]Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance and CE mark for its Halcyon and Ethos systems.

Both radiotherapy systems feature Varian’s HyperSight imaging solution. HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. The images help in the daily localization of patient tumors and their uses include replanning and adaptation to patient and tumor changes.

HyperSight uses cone-beam computed tomography (CBCT) technology. This delivers larger images with better contrast. Varian said in a news release that this method is 10 times faster than conventional linear accelerator-based imaging systems. Traditional CBCT imaging may take up to 60 seconds and require patients to hold their breath. HyperSight acquires images in six seconds, potentially minimizing patient discomfort and anxiety while offering …

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Varian wins FDA IDE for Flash radiation therapy

Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical research program.

Flash therapy, an experimental treatment modality, was designed to deliver radiation therapy at ultra-high dose rates in typically less than one second.

The Siemens Healthineers company will conduct the feasibility study of Flash therapy for the treatment of symptomatic bone metastases (FAST-02) with the IDE now secured, according to a news release.

“Receiving IDE approval for FAST-02 reaffirms our confidence in the potential of Flash therapy and represents an important step toward delivering this groundbreaking therapy in a clinical setting,” Varian VP of Flash Solutions Agam Sharda said in the release. “Together with our FlashForward Consortium, we have expanded Flash therapy research using our systems as we work to improve the patient experience. We look forward to continuing to collaborate with experts aro…

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Siemens Healthineers’ Varian faces scrutiny over environmental cleanup at former Massachusetts site

Varian could reportedly face punishment due to the spread of toxic chemicals relating back to its former property in Massachusetts.

The Salem News reported yesterday that more than 21 years ago, Beverly, Massachusetts officials requested that Varian — which was acquired by Siemens Healthineers in a $16.4 billion deal last year — test the bedrock on a part of its former property to assess if it might be a source of the spread of toxic chemicals in the surrounding area. According to that report, Varian said the tests weren’t necessary and did not carry them through.

Last November, after the tests were finally conducted, they reportedly revealed that levels of cancer-causing trichloroethylene came in at 600,000 parts per billion — about double the amount that raises concerns about indoor air for experts, according to The Salem News.

As a result, the Massachusetts Department of Environmental Protection ruled that Varian’s cleanup operation is not…

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Varian wins FDA breakthrough nod for microspheres that treat knee osteoarthritis

Varian announced today that it received FDA breakthrough device designation for its Embozene microspheres for treating knee osteoarthritis.

Palo Alto, California-based Varian, a Siemens Healthineers (ETR:SHL) company, designed Embozene for genicular artery embolization (GAE) in treating symptomatic knee osteoarthritis. Embozene already holds FDA clearance for the embolization of hypervascular tumors, arteriovenous malformations, uterine fibroids and benign prostatic hyperplasia.

GAE as a treatment is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process, according to a news release.

UCLA Santa Monica and the David Geffen School of Medicine at UCLA director of interventional radiology Dr. Siddharth Padia said in the release that GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration.

According to Padia, a 40-patient study…

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Varian wins FDA breakthrough nod for cardiac radioablation system

Varian announced today that it received FDA breakthrough device designation for its cardiac radioablation (CRA) system.

Palo Alto, Calif.-based Varian, a recently acquired Siemens Healthineers company, developed the CRA system as a noninvasive therapy for select patients with refractory ventricular tachycardia (VT), according to a news release.

VT, a fast, abnormal heart rate that could lead to sudden cardiac arrest, can be treated with an implantable cardioverter-defibrillator (ICD), antiarrhythmic medications or an invasive catheter ablation procedure. Still, Varian says those methods are often insufficient in controlling VT.

The Varian CRA system won the breakthrough nod because it could offer a more effective treatment for refractory VT through the noninvasive targeting and delivery of ablative energy across the full thickness of the myocardium, unlike conventional catheter ablation.

Varian believes that if the planned clinical studies support…

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DTW Podcast: How is Zimmer Biomet waging the ortho data war? Do medical devices carry physics-based biases?

This week’s DeviceTalks Weekly Podcast guests

In this week’s DeviceTalks Weekly Podcast,  Liane Teplitsky, vice president and general manager of worldwide robotics at Zimmer Biomet, shares her excitement for the burgeoning data business emerging in orthopedics.

Teplitsky, an engineer who built her medtech career in cardiac R&D and sales at St. Jude and Abbott, walks us through the interconnected offerings of Zimmer’s ZB edge suite of digital and robotics technologies.

In a separate interview, we talk with Achuta Kadambi, assistant professor at the UCLA Samueli School of Engineering, about a column he contributed to Science suggesting physics may be causing medical devices to perform at varying levels in people of different races.

Kadambi explains his own work in the field and suggests how medical device developers may want to move forward in the future.

See our initial report in Medical Design and Outsourcing here.

Chris New…

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Siemens Healthineers completes Varian acquisition

Siemens Healthineers (ETR:SHL) announced today that it completed its acquisition of Varian Medical Systems (NYSE:VAR).

In August, the companies announced that Siemens would acquire Varian in a $16.4 billion deal to create what the companies said will be the most comprehensive cancer care portfolio in the industry. Varian shareholders approved the deal in October. Several personnel moves have followed, including the planned retirement of Varian CEO Dow Wilson and the resignation of Varian CFO J. Michael Bruff.

Following today’s closing of the acquisition, Varian is expected to positively contribute to Siemens Healthineers’ adjusted basic earnings per share within the first 12 months, according to a news release.

The two companies are building on a strategic partnership called EnVision, which sets out to establish a digital, diagnostic and therapeutic ecosystem that includes treatment management. Siemens and Varian are set to use AI-assisted an…

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MedTech 100 roundup: Industry roars back

In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels.

MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark set a week prior (April 2).

The industry’s rebound has been impressive, given that just over one month prior, the index had dropped to 102.16 points (March 8), having just set its all-time best of 110.96 on Feb. 15. Medtech companies had no seen that degree of a fall since October 2020.

Improvements highlight the secure position the industry has nestled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry has produced an 18.5% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 76.1% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall …

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DTW Podcast: Herrera on how military lessons led to Medtech career; Ulmer ready to redo landmark FDA survey

Derek Herrera and Kwame Ulmer are featured on this week’s DeviceTalks Weekly Podcast.

In this week’s podcast, Derek Herrera explains how a serious battle injury he received while leading Marines in Afghanistan led him to build a career in medtech.

Herrera has founded two companies – Spinal Singularity and Habit Camera – to create devices that can improve and save the lives of people who need help the most. Herrera also explains how his military training is serving him so well in medtech and how the medical device industry would benefit from including more veterans in its workforce.

We’ll also hear from Kwame Ulmer, principal at Ulmer Ventures and a lecturer at UCLA Anderson’s School of Management, about an effort his helping to lead to update the landmark study compiled by Josh Makower in 2010. The study blasted a regulatory process that it called “unpredictable, inefficient and expensive.”

Its finding led to introspection and changes, according to…

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