Armed with new clinical data and FDA clearance (for expanded labeling purposes) of strong diagnostic performance claims, computer-controlled light box manufacturer SmartLight is talking with several medical imaging OEMs about partnerships aimed at
Armed with new clinical data and FDA clearance (for expanded labeling purposes) of strong diagnostic performance claims, computer-controlled light box manufacturer SmartLight is talking with several medical imaging OEMs about partnerships aimed at producing the integrated digital and hard-copy x-ray reading room of the future, according to Robert Sohval, CEO of the Israeli firms U.S. subsidiary, based in Hackensack, NJ.
The talks moved into high gear at last years RSNA show, where SmartLight had meetings with the top management of more than half a dozen OEMs. As of last week, SmartLight was continuing discussions with several OEM candidates, he said.
While Fuji and Siemens currently help distribute SmartLight products, the new type of relationship being explored would move beyond sales to include the joint development of reading room systems that would combine PACS with SmartLights computerized optics for film reading.
These intensive discussions coincided with a SmartLight corporate decision to pursue strategic alliances with appropriate OEM partners, Sohval said.
SmartLight expects to continue direct sales of its light boxes worldwide, although the OEM focus, if successful, could begin to take on a greater focus at the company. Medical imaging OEMs are interested in the SmartLight technology because it addresses weak links in the imaging chain, according to Sohval. Those are the continued preference of radiologists for diagnosing from film rather than newer digital displays and the lack of improvements in standard film reading technology.
SmartLights claim that it substantially improves the ability of doctors to detect lesions reading x-ray film received a boost last year with results from a large clinical study that looked at the impact of the technology on the diagnoses of over 1000 radiologists. The first scientific presentation of these results was given at the RSNA conference.
One of the most important results of the study was to demonstrate that the ability to detect lesions on film degrades with the increasing age of the reader, Sohval said. SmartLight is able to compensate for changes in eyesight by fine-tuning the optics of the system to match the needs of the individual reader.
A 55-year-old radiologist reading on a SmartLight outperforms a 30-year-old radiologist reading on a conventional view box, Sohval said.
This study was used by the FDA last June (SCAN 6/23/99) in expanding the labeling of SmartLights technology. The agency allowed the claim, submitted in SmartLights 510(k) application, that it substantially improves readers ability to detect radiographic detail and clinical information over other film viewers.
Having the FDA support a claim of superior performance is a rarity, Sohval said. Normally, a 510(k) application to the FDA claims only substantial equivalence to existing technology. Even a pre-market approval (PMA) application focuses on safety and efficacy rather than performance claims.
We have been told this is the first time in diagnostic imaging that the FDA has awarded a claim where new technology is (deemed) superior to the prevailing standard of care, he said.
SmartLight was fortunate to receive its expanded FDA clearance shortly after the Mammography Quality Standards Act (MQSA) went into effect in the U.S. in April. Over the last nine months, 70% of the demand for SmartLight products has been for mammography applications, Sohval said.
The company also scored a coup when, right before the RSNA show, Ireland picked SmartLight as the film reading technology for use in its new national breast screening program. Every center participating in the program will be reading mammograms on a SmartLight system.
SmartLight also used the RSNA show to announce a sharp drop in pricing for its entire line. The move was made possible by a technological breakthrough that reduced the companys production costs for its proprietary optics technology, according to Sohval.
The SmartLight 2000, introduced at $24,000, now sells for $14,000. The SmartLight 4000 (with four panels rather than two) lists for $25,000, down from $45,000. The new motorized viewer SmartLight introduced at the RSNA meeting, the SL8000SLX, has a base configuration priced at $55,000.
Lower prices should dramatically expand access to this technology beyond luminary sites, Sohval said. SmartLight has installed hundreds of its systems worldwide. One-third to a half of their business is in the U.S.
Several technological advances were introduced at the RSNA show in addition to the new motorized viewer. One important advance, the personality profile, has been incorporated first in the SL8000SLX but will eventually be added to the other SmartLight products, Sohval said. This feature allows each user to punch in an identification number that will automatically optimize viewing conditions for his or her profile.
The system defaults to the brightness that maximizes your visual acuity. Scanning speeds are optimized for your reading habits, he said. This both improves (diagnostic) quality and speeds your personal workflow.