The holidays and RSNA are upon us, which can only mean one thing: It’s time to start looking back at 2017 and compiling lists of the biggest events of the year.

For HealthCare Business News, that means looking at the stories that have shaken up the medical industry.

Whether it be the FDA approving new technology, researchers adding clarity to the way certain treatments impact patient outcomes, shifting focal points among the major OEMs or legislation poised to change the way hospitals think about their budgets and service contracts — there has been no shortage of high-impact headlines in 2017.

The editorial staff at HCB News has chiseled them down to the following eight items.

7T MR enters U.S. market

The fact that the tech climate has shifted decidedly toward software and processing capabilities made the FDA clearance of the Siemens Healthineers 7 Tesla MAGNETOM Terra in October that much more remarkable.

To give some perspective, the majority of MR scanners on the market are still 1.5 Tesla (a unit of magnet strength named for Nikola Tesla) and 3 Tesla systems (the highest strength magnets that had been on the market) have already been available for nearly 20 years.

With the system’s ultra-high-field magnet strength, the MAGNETOM Terra may help clinicians visualize previously unseen anatomical structures, forging new inroads toward a more complete understanding of disease and human anatomy.

“The overall image quality of MR improves with higher magnetic field strength,” stated Robert Ochs, director of the Division of Radiological Health in the FDA’s Center for Devices and Radiological Health. “The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”

According to Siemens, the MAGNETOM Terra is ideal for performing neurological and musculoskeletal exams and has more than double the signal-to-noise ratio of a standard 3T system. Its hyper-fast image reconstruction technology also makes it up to 20 times faster than previous generations of 7T research systems.

Amazon ramps up interest in health care

From its relatively humble beginnings as an Internet book store to its global dominance as a one-stop shop for virtually everything, it’s long been evident that Amazon and its CEO Jeff Bezos are always looking for growth opportunities.

This summer, the company set up “1492,” a secret “skunk works” lab aimed at assessing health care opportunities from EMR to telemedicine while focusing both on hardware and software, according to July reports. Meanwhile, health care providers have already been looking at ways to use Alexa, the Amazon-built intelligent personal assistant, for things such as recordkeeping and transcription.



Health IT and voice recognition software aside, industry murmurs suggest Amazon may also be planning to stake a claim in the pharmaceutical industry.

According to various news outlets, inside sources have hinted that the yes-or-no decision to start selling prescription drugs online could come before Thanksgiving. The suddenly larger retail footprint provided by Amazon’s acquisition of Whole Foods earlier this year could make an easier fit for a brick-and-mortar pharmacy move, as well.

The move into health care was hinted at when Bezos spoke with Walter Isaacson, president of the Aspen Institute, at the Vanity Fair New Establishment Summit in October 2016.

“I think health care is going to be one of those industries that is elevated and made better by machine learning and artificial intelligence,” Bezos told the crowd, adding, “And I actually think Echo and Alexa do have a role to play in that.”

Increased scrutiny of widely held notions of radiation dose danger

This year has seen experts taking up the controversial cause of questioning the widely held belief that medical imaging dose exposure is dangerous.

Through respected platforms like the Journal of Nuclear Medicine (JNM), researchers in 2017 made the case that sound evidence does not exist to justify the level of public anxiety associated with imaging scans. They argue that being overly cautious actually hurts patients, because fear leads to not receiving the proper diagnostic exams and therefore may lead to other issues.



The basis for the argument has to do with the linear non-threshold model, which essentially states that if a large dose of radiation is very bad then a small dose of radiation must be a little bad, an assumption that some experts claim is not based on scientific evidence.

“I really want to stir [it] up and put an end to this controversy,” Jeffry Siegel, Ph.D., president and CEO of the consulting firm Nuclear Physics, and lead author of the JNM study, told HCB News. “I can’t believe this linear no-threshold model debate has been going on for so long ... reinforcing radiophobia that has parents telling their pediatrician they don’t want their child to have a needed CT scan.”

In September, British researchers published findings in The Proceedings of the Royal Society B. showing that low-level ionizing radiation exposure poses less risk to health than obesity, smoking or air pollution, while drawing up a concise perspective on the subject that can be understood by readers outside the study of medicine.

Angela McLean, a professor of mathematical biology at the University of Oxford and the lead author of that study, told HCB News that although the study is not meant to recommend changes in policy, she hopes it will create more informed discussions on the use and risks of low-level ionizing radiation.

Automated breast ultrasound: Dense tissue game-changer?

Since dense breast tissue can hide cancer on mammography, secondary imaging modalities (like tomosynthesis and molecular breast imaging, for example) have been on the rise in recent years.

While there is no one secondary imaging answer, NorthShore University Health System in Chicago announced in March that it has doubled its cancer detection rate performing 40 automated breast ultrasound (ABUS) exams per day.



“Over the past several years, one of the biggest challenges is detecting breast cancer in women who have dense or extremely dense breast tissue,” Dr. Georgia Giakoumis Spear, chief of the department of breast imaging at NorthShore, told HCB News. “We know that there are limitations with mammography alone and that we are missing up to one-third of breast cancer in this population of patients.”

The health system runs four hospitals and five satellite imaging centers with a staff of 13 dedicated breast imagers. In November 2015, they deployed two of GE Healthcare’s Invenia ABUS systems and after eight months they purchased another two systems.

NorthShore decided ABUS was a better option than handheld ultrasound because it offers more reproducibility and consistency, which means there is less room for error when conducting the exams.

A technologist can complete the scan in 15 to 20 minutes and the images are then post-processed on a workstation, where the radiologist can view them in 3-D planes.

Over the next three years, Spear and her colleagues will conduct a clinical trial to establish the efficacy of ABUS as a breast cancer screening solution.

“We hope it will help establish much needed practice guidelines on how to implement such a program and utilize this tool,” she said.

Varian’s Halcyon linac offers high capability radiotherapy at a competitive price

Varian Medical Systems unveiled its Halcyon linear accelerator for image-guided volumetric intensity modulated radiotherapy in May, touting the system as being twice as fast as other radiotherapy modalities on the market.

The system, which can complete certain treatments in as little as 13 minutes, was designed for simplicity and requires only nine steps where conventional systems may require 30 or more.



“Everyone knows there’s a shift in health care economics in the U.S., but in other countries everyone is focused on efficiency,” Mu Young Lee, director of new product solutions at Varian, told HCB News. “Whether you’re in China or France or America, we have an aging population everywhere, so the need for efficiency is important worldwide.”

The Halcyon was also designed to yield economic advantages in overall cost of ownership. It comes pre-commissioned, requires less shielding than traditional systems and can fit in a vault as small as 19.68 feet x 18.17 feet x 8.99 feet high and can be installed in two weeks or less.

The main problem hospitals will face in the next five to 10 years is a lack of clinicians to care for the growing elderly population, according to Lee. Halcyon is intended to deliver high-quality treatment to a wide range of patients.

In order to support the gantry rotation speed and simultaneously deliver the treatment dose precisely to the targeted area, the Halcyon is designed with a patented dual-layer, multi-leaf collimator that moves twice as fast as standard MLCs.

The system had received regulatory clearance for marketing in the U.S. and Europe in June.

Toshiba Medical Systems is poised to become Canon Medical Systems

As the medical imaging industry stands by and watches, Canon is finally gearing up to integrate Toshiba’s former medical unit fully into its business.

Toshiba Medical Systems Corporation will be officially renamed Canon Medical Systems Corporation on Jan. 4, 2018, following a much publicized, and controversially structured, deal between the pair that saw the entity’s departure from the Toshiba Group last year.



Since then, a lengthy regulatory approval process has taken place to complete the integration of the unit, necessitated by the global nature of the company that demanded it follow a variety of national or regional laws covering both pharmaceuticals and medical devices.

All the while, Canon executives have been stressing that the synergy from the deal will put the company in a position to take on world leaders in the health care equipment and information technology sectors.

In October, the company announced ambitious financial goals, including seeking a group revenue increase of over $44 billion with 15 percent operating profit margins and net profit margins of over 10 percent by 2020.

“We have now lined up new businesses in four key growth areas — commercial printing, network cameras, industrial devices and health care,” said Fujio Mitarai, Canon’s chairman and CEO. “From this year, we plan to redouble our efforts, particularly in health care.”

The Toshiba Medical deal is the crown jewel of the repositioning plan as health care is “an area of the greatest potential,” according to the company.

Watching how Canon Medical Systems harnesses that potential will likely be one of the top stories for 2018.

Philips gets FDA approval for digital pathology solution

Disruption is a buzzword that gets thrown around too much in health care, but it seems safe to say that digital pathology is poised to completely disrupt the clinical lab workflow. What is typically accomplished by combining biopsy specimens with delicate glass slides and carefully focused microscopes is undergoing a computerized upgrade.

In April, Philips IntelliSite Pathology Solution became the first whole-slide imaging system that can be used to review and interpret digital surgical pathology slides prepared from biopsied tissue for primary diagnostic use. Until then, the system was only approved by the FDA to be used as an aid to the pathologist when detecting HER2 expression in breast cancer.



The FDA evaluated data from a clinical study that involved about 2,000 surgical pathology cases. It was one of the largest studies that directly compared the use of digital pathology to conventional optical microscopes.

Sixteen pathologists at Cleveland Clinic, the University of Virginia, Miraca Life Sciences and Advanced Pathology Associates performed about 16,000 reads of the cases. The results showed that the diagnoses made using PIPS were comparable to those made using the conventional method.

“It allows pathologists to simplify access to histopathology information and work more efficiently,” Russ Granzow, general manager of Philips Digital Pathology Solutions, told HCB News. “The pathologists will have the agility to view digital images and aim to extend collaboration with peers, with the aim of increasing diagnostic confidence.”

Digital pathology has been a major focus for Philips in recent years. In June 2016, the company acquired PathXL’s digital pathology portfolio. More recently in March, it partnered with a developer of artificial intelligence technology for pathology called PathAI.

FDA required to issue report assessing independent service organizations

The drama surrounding third-party service saw some significant progress toward resolution in 2017. It’s possible that we will be even closer to a conclusion between the time of this publication and when the year actually comes to an end.

It all started in early 2016 when the FDA opened a docket aimed at defining certain terms associated with non-OEM service pertaining to medical equipment. Roughly 176 organizations chimed in (some citing the lack of oversight third parties have through regulations, others pointing out the private interests OEMs have in eliminating competition).



What followed was a two-day workshop at the FDA headquarters in Silver Spring, Md., where stakeholders representing OEMs and third parties engaged in lively debate.

With the Medical Device User Fee Act signed into law by President Donald Trump in August, the FDA was given 270 days to issue a report on the service of medical devices as it pertains to patient safety.

The report, which will be posted to the FDA website, will also evaluate comments received from the initial docket and the workshop.

There is some speculation that the FDA may issue the report in advance of the congressionally imposed deadline. Since the completion of the two-day workshop, the FDA, principally through a 10-person internal FDA workgroup, has been hard at work carefully evaluating the comments and testimony received, while also listening to many different stakeholders.

The outcome of the investigation could cause major repercussions in health care and how hospitals think about equipment purchases and service contracts.