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The AI Threat | No New Service Regulations | Tariff Fight Heats Up | The Imaging Wire

The AI Threat | No New Service Regulations | Tariff Fight Heats Up

Plain and simple, this is about patient safety. Patients should not have to risk taking a leap of faith regarding the upkeep of their medical device, . . . While many third-party servicers perform high-quality work, waiting for adverse events to occur before quality controls are put in place to receive and track adverse events is not in the best interests of patients.

– MITA executive director, Patrick Hope, in a statement urging congress to require third party medical imaging servicers to register with the FDA and report adverse events, following the FDA’s decision not to regulate 3rd parties.


The Imaging Wire

 Another Article About the Threat of AI
The JACR made headlines with a recent article, suggesting that artificial intelligence may make radiologists less necessary. The article forecast that due to the growing contribution of AI, healthcare systems will require far fewer radiologists (currently 34k in the US) and the radiologists who remain must do more than simply interpret imaging studies. The article stopped short of predicting the final impact of AI on the radiology profession or the pace that this change will occur, but was quite clear in its prediction that AI solutions for medical imaging will continue to grow in number and capabilities, changing radiology forever. The Imaging Wire’s take: This article could be written for hundreds of professions, from truckers to lawyers, and it would be accurate for each. It’s up to all of us to embrace the benefits of AI and start developing skills that are less easily replaced by machines.

FDA Guiding (Not Regulating) Third Party Service Providers
Third party medical device servicers breathed a sigh of relief following a recent congress-mandated report from the FDA that found insufficient reason to add new regulations for 3rd parties. Instead, the FDA will work with 3rd party servicers to: promote adoption of quality management principles, clarify the difference between servicing and remanufacturing, improve cybersecurity practices, and drive the development of criteria to assess medical device servicing. Manufacturers (whose service is FDA-regulated) understandably had a different perspective on the decision, as MITA called on Congress to step-in and require that 3rd party servicers register with the FDA and report adverse events (this seems reasonable).

NEMA Takes a Stand Against China Tariffs
Trump’s proposed China tariffs re-emerged in the medical imaging headlines, when NEMA testified that the medical imaging industry would indeed be materially affected by the proposed 25% duty on 1,300 targeted products imported from China (including over 100 medical imaging products and components). NEMA estimated the 2017 value of these imported medical imaging products at $9 billion, representing a $2.25 billion tax increase on the industry. Citing US-based manufacturers’ existing disadvantage related to the steel and aluminum imports, NEMA urged the government to consider alternative measures. GE separately ramped-up its efforts against the tariffs, revealing that a quarter of components used in its devices are China-made (the rest are US-made), and similarly warning that these tariffs would place a burden on the company and its clients. NEMA is doing exactly what it’s supposed to do here, but it may take more direct influencing from heavy-hitters like GE, and some geopolitical good fortune to avoid these tariffs.

FDA hits RadLogics with Warning Letter
The FDA issued a warning letter to RadLogics, arguing that the company is marketing its AlphaPoint medical imaging data analysis software (since renamed Virtual Resident) with performance claims that go “significantly beyond” its 510k clearance. Specifically, the FDA takes issue with RadLogics’ online (website and YouTube) claims that AlphaPoint provides computer-assisted detection (CADe) of abnormalities in radiology images, rather than simply assisting with image interpretations. The company reportedly already responded to the letter and changed its messaging (and changed the product’s name) just in time for…

RadLogics Acquired by Pair of Asian Investment Firms
RadLogics was acquired by East Ocean Ventures of Singapore and Tianjin Dazhen Asset Management of China, targeting a Q3 2018 close date following regulatory approval. RadLogics is best known for its AlphaPoint software (now called Virtual Resident), which uses machine learning to support medical image interpretation. The companies plan to increase R&D investments, create a new business unit in Asia, and expand sales distribution in the US and Asia, emphasizing that Asia offers the greatest growth opportunities for the company.


The Wire

  • MR Solutions expanded its preclinical scanner portfolio with the launch of four new CT scanners that can operate independently or with the company’s clip-on PET and SPECT imaging systems, joining its already-broad preclinical portfolio (six MRI, five PET, and two SPECT cryogen-free scanners).
  • Balancing-out all the recent articles about the threat of AI, a report from the JACR found that radiologists serve more Medicare beneficiaries than any other specialty (followed by cardiology, cardiac electrophysiology, dermatology, and urology), using the finding to underscore the key role radiologists play in patient care.
  • Brainomix received CE approval for its e-CTA AI software, which is used to interpret CT angiography images of acute stroke patients by showing heat map assessments of collateral blood supply and by visualizing brain vessels.
  • Curium announced its re-entry into the US Xenon Xe 133 Gas market, sourcing the radiopharmaceutical from its LEU-based Petten manufacturing facility, which reportedly allows for vertical integration and ensures ongoing product availability.
  • A decade-old story warning against wearing yoga pants during MRI procedures resurfaced in both industry and mainstream press (where it was covered as a new storyline), reminding patients and clinicians that clothing with metallic fibers can heat quickly during scans and may cause serious burns.
  • A JACR study revealed a that 2.26% of all patients “no-showed” for their medical imaging examinations in 2015, citing mammography with the highest no-show rate (6.99%), suggesting that discomfort, long scheduling lead-times (>6mos), patent age (>60yrs), and day of the week (Mon & Sat) had the greatest contribution to no-shows.
  • Mach7 Technologies and Client Outlook expanded their partnership to offer a new PACS system that they claim is a true enterprise solution, offering a level of enterprise flexibility and interoperability not available in legacy departmental-focused PACS systems.
  • A report from Stericycle Expert Solutions revealed that medical device recalls increased 126% in Q1 2018 (most since at least 2005), as the quarter brought 343 separate recalls impacting 208 million units (607k avg. units per recall), pointing to software issues and mislabeling as the leading factors driving recalls.
  • CurveBeam’s LineUp multi-extremity weight-bearing CT scanner received FDA 510k clearance, which performs 3D visualization the lower extremities (heel to knee) while the patient is standing and can also visualize the arm (hand to elbow) with the addition of accessories.
  • Carestream announced that WVU Medicine installed five DRX-Evolution Plus Systems and 12 DRX-Revolution Mobile X-ray Systems at J.W. Ruby Memorial Hospital’s outpatient center and the healthcare system’s Fairmont Urgent Care Clinic.

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