Analogic, a Private Company
Analogic was acquired by private equity firm, Altaris Capital Partners, for $1.1 billion in an effort to achieve greater scale and drive future growth amid fierce competition. The deal comes 10 months after Analogic announced plans to seek strategic alternatives and follows a lengthy sales process that included discussions with 75 parties. Altaris owns 12 other medical companies, and Analogic suggested that in addition to funding R&D for development of medical imaging components, Altaris’ connections and strengths (manufacturing and operations) should help the company scale in the future.

New FDA 510(k) Clearance Option Proposed
The FDA proposed a new 510(k) application option for “moderate risk” devices, intended to streamline the review process for applicants and the FDA’s own staff. The new option expands the 20-year old Abbreviated 510(k) program, allowing manufacturers to use device performance to achieve clearance, rather than via comparisons to predicate products. The FDA admitted that predicates can be old and sometimes do not feature modern technology and requiring direct comparisons places too much of a burden on applicants, especially when tested against a “substantial number” of predicates.

Merry X-Ray Still Acquiring
There is a reason the president of Merry X-Ray’s LinkedIn role description starts with “Currently conducting mergers and acquisitions.” Merry X-Ray announced its acquisition of Nationwide Imaging Services of Manasquan, New Jersey, further expanding the company’s service and reconditioned sales capabilities, giving the major distributor its first international distribution business. Merry X-Ray already had a strong presence of new equipment dealerships. Since late 2017 the company’s five acquisitions have significantly expanded its capabilities around service, reconditioning, parts, and international distribution.

Canon and NVIDIA’s Deep Learning Deal
Canon Medical Systems and NVIDIA signed a (currently) Japan-only partnership to develop and sell deep learning research infrastructure to Japanese medical research institutions. Through the partnership, Canon Medical Systems will utilize the NVIDIA DGX systems to process data generated by Canon’s proprietary Abierto VNA system and then share these data with medical research clients.

ITEM Japan Announcements Keep Rolling in
The third installment of launch announcements from the ITEM show in Japan hit the presses, featuring launches from Canon, Hitachi, GE, Philips, Shimadzu, and Siemens, including a number of products making their first worldwide appearance.

• GE Healthcare announced the Japan launch of the second generation of the SIGNA Voyager and SIGNA Artist wide bore G2 1.5T MRI systems. The new systems adopt GE’s SIGNA Works MR solutions platform and launch with updates to static magnetic field homogeneity, gradient magnetic field, Radio Frequency, image calculation and analysis time, among others. It’s unclear if these new features are indeed new outside of Japan or how this launch will impact GE’s SIGNA line in other regions.
• Previously available in Europe, GE Healthcare’s Senographe Crystal Nova digital mammography system launched in Japan. The new system is highlighted by its lower cost and small size, while still offering higher-end DQE and speed, as well as lower dose levels. The Senographe Crystal Nova is not yet available in the US but could emerge stateside in the future.
• Siemens launched the MAMMOMAT Revelation in Japan, just a few weeks after the mammography platform received FDA clearance in the US. The premium system launches with the new InSpect integrated specimen imaging tool, new “one-click” HD breast biopsy solution, and what Siemens claims is the widest image acquisition angle available (50 degrees), and the industry’s highest depth resolution.
• Canon Medical Systems Japan started domestic sales of the Vantage Orian premium 1.5 Tesla MRI system, roughly six weeks after the system launched in Europe at ECR. The Vantage Orian is Canon/Toshiba’s first premium wide-bore 1.5-tesla MRI and joins its current 1.5-tesla lineup, including the wide-bore Vantage Titan and standard-bore Vantage Elan.
• Philips Japan unveiled the IQon Elite Spectral dual layer CT, an updated version of the IQon Spectral CT with changes meant to improve diagnostic confidence and the patient experience. The IQon Spectral CT debuted at RSNA 2017 and is expected to ship globally.
• Hitachi Japan highlighted the use of Microsoft’s mixed reality HoloLens with the Hitachi-developed OPERADA mixed reality content solution. The MR solution is used to create “virtual medical equipment” and a “virtual operating room,” particularly intended to support education and procedure planning.
• Shimadzu announced the Japan launch of the MobileDaRt Evolution MX8 digital mobile DR X-ray with new image processing and reduced electricity consumption. The MX8 was already announced in Western markets.

The Wire

• Siemens and SAS signed a machine learning and IoT analytics solutions deal to manage data from Siemens’ global medical imaging install base, with the goal of helping predict system problems and potential downtime several days before a failure.

• Philips and major Chinese cloud-healthcare company, Digital China Health, partnered to create SHINEFLY, a teleradiology service for the Chinese market that leverages Philips’ image information and analysis tools to support small and remote hospitals.

• Ambra Health signed a deal with major Japanese medical distributor, MC Healthcare, to launch Ambra’s cloud medical imaging platform in Japan.

• Ikonopedia introduced its new breast ultrasound reporting module, featuring a BI-RADS compliant interface, designed to streamline screening and diagnostic reporting following both automated breast ultrasound and handheld ultrasound exams.

• Konica Minolta Healthcare Americas announced an agreement to distribute HydroCision’s TenJet Percutaneous Tenotomy System for minimally invasive tenotomy procedures, supporting KM’s strategy to advance MSK ultrasound and related procedures.

• An AI algorithm from Dubai Health Authority in partnership with Agfa HealthCare and VRVis Vienna was able to identify diseases in 4,900 chest X-rays at 95% accuracy.

The Resource Wire

• Agfa whitepaper on augmented intelligence and intelligent workflows
• Caresteam video interview details Clinical Collaboration Platform success story
• Canon and Toshiba publish “New Horizons in Ultrasound” report
• Fujifilm video outlines its women’s health solutions
• GE video overview on Centricity Universal Viewer
• IBM Watson post highlights client success at The Iowa Clinic
• Konica Minolta publishes latest Kontours issue
• Olympus webinar on bringing endoscopic ultrasound to community hospitals
• Olympus video on the benefits of using CO2 in endoscopy
• Philips article highlights pediatric radiology innovations
• Philips video highlights its radiology solutions at ECR 2018
• Philips article on managing cybersecurity risks in healthcare
• Siemens video on digitalizing healthcare in radiology
• Siemens and the HBR’s perspective on transforming care delivery
• Siemens and the HBR paper on “The Power of Digitalizing Healthcare”
• Siemens video on expanding precision medicine with BioMatrix technology