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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12 of medtech’s biggest personnel changes in 2021

As medtech companies continued to drive innovation throughout the past 12 months, a number of high-level executives led the way.

Some of those companies and those executives opted for major changes over the course of 2021, though, with some high-profile moves from medtech giant to medtech giant.

Here are some of the biggest personnel moves in the medtech space in 2021:

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

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Baxter, 3M, Abbott near the top of Newsweeks’ most reponsible companies list

Several medtech, healthcare and life sciences companies, including big names like Abbott (NYSE:ABT), 3M (NYSE:MMM) and Baxter (NYSE:BAX), are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined environmental, social and corporate governance performance assessments.

Baxter, 3M, Abbott and BD (NYSE:BDX) were among the highest-ranking big-name medical device makers. Cancer diagnostic company Illumina was the highest-ranking company under the healthcare and life sciences umbrella, sitting in second behind HP.

In sixth sat Baxter, registering an overall score of 89.5 points, with its highest performance coming in environmental i…

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Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

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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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Siemens Healthineers ticks up on Q2 earnings, raised guidance

Siemens Healthineers (ETR:SHL) shares ticked up today on strong second-quarter results and raised guidance for 2021.

The Erlangen, Germany-based company posted profits of $539 million (€447 million), or 50¢ per share, on sales of $4.8 billion for the three months ended March 31, 2021, for an 8% bottom-line gain on sales growth of 7.6%.

Adjusted to exclude one-time items, earnings per share were 53¢ for the company that earlier this month completed a massive $16.4 billion purchase of Varian Medical Systems.

Siemens Healthineers’ diagnostics business was a major growth driver, with sales rising 29.1% year-over-year amid high demand for the company’s rapid COVID-19 antigen tests, according to a news release.

Additionally, the company’s imaging business saw revenue growth of 7.4% in imaging and sales numbers grew 2% in advanced therapies.

“The Siemens Healthineers team has done an outstanding job during the past months. …

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MedTech 100 roundup: Industry skies to all-time high

The medtech industry hit a slight lull in the early stages of 2021 and, after signs of a rebound, it has soared beyond levels ever before seen.

MassDevice‘s MedTech 100 Index had been building up steam in the month of April, rising from 102.16 points at the beginning of March all the way to 109.39 to end the week before last (April 9). Having only set its previous all-time best of 110.96 on Feb. 15, the industry’s topsy-turvy run gave no indication of which direction it was heading next.

However, after the rise over the past couple of weeks, the industry rode that wave to a new all-time high of 112.25 to end last week on April 16. That represents a 2.6% rise from the previous week’s tally.

Improvements continue to shine a light on the strong position the industry has settled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry has produced an 21.6% rise from the pre-pandemic high of 92.32 (set on Feb. 1…

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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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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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Varian CFO resigning ahead of Siemens Healthineers acquisition

Varian Medical Systems CFO J. Michael Bruff has decided to resign from the company to pursue other opportunities.

In an announcement released yesterday, the company confirmed that Bruff’s decision will be made effective on March 12, 2021, with SVP, chief accounting officer and corporate controller Magnus Momsen set to serve in the role on an interim basis.

Momsen, 46, has served in the three roles he currently holds, plus as the company’s principal accounting officer, since January 2017, having joined the company in September 2010 as the controller of emerging businesses.

Bruff’s decision to depart the company comes on the heels of last week’s announcement that that CEO Dow Wilson will retire after Siemens Healthineers‘ planned $16.4 billion acquisition of the company, which is expected to close in the first half of this year.

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Varian CEO Dow Wilson to retire after merger with Siemens Healthineers

Varian CEO Dow Wilson

Varian (NYSE: VAR) announced today that CEO Dow Wilson will retire after Siemens Healthineers‘ planned $16.4 billion acquisition of the company, which is expected to close in the first half of this year.

Wilson, who has been with Varian for 16 years, will serve as a special advisor to Siemens Healthineers (Frankfurt: SHL) to help support the integration. Varian COO Chris Toth will become CEO of Siemens Healthineers’ new Varian business segment.

“Since his appointment as CEO in 2012, Dow has led Varian’s efforts to define a new era in cancer care,” Varian board chair Andrew Eckert said in a news release.

“In addition to significantly extending the company’s market leadership and innovation in radiation therapy, he oversaw Varian’s progress in bringing artificial intelligence, machine learning and cloud solutions to the fight against cancer. Through this strategic transformation, Varian …

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