September 02, 2014 “Intelligence: Late- Breaking News”

There will be one less vendor of laboratory information systems (LIS) when a major acquisition is completed. Last month, Siemens AG announced that it would sell Siemens Health Services to Cerner Corp. for a price of $1.3 billion. Analysts believe that Cerner was motivated to do the deal because, among other benefits, it would gain inside access to sell its EHR solution to customers of SHS. The sale is expected to close in the first quarter of 2015. SHS uses the brand name of “Soarian” for its LIS and other software systems.

MORE ON: Siemens

Also in August, Siemens agreed to sell the clinical microbiology business of Siemens Diagnostics to Beckman Coulter Corporation, a subsidiary of Danaher Corporation. No sales price was disclosed and the sale is expected to close in the first quarter of 2015. Analysts noted that, under Siemens, this business unit has more than 6,000 Microscan microbiology instruments placed globally. With this product line, Beckman Coulter will be in a better position to be a sole source vendor to clinical laboratories.

FDA PREPARES TO REGULATE LDTs

By now, most pathologists and lab managers know that the Food & Drug Administration gave the legally-required 60- day notice to Congress on July 31 that it intended to regulate laboratory-developed tests (LDTs). The FDA’s draft guidance it provided to Congress provides useful insights on what labs with LDTs will need to do to gain FDA clearance for their LDTS. On September 17, THE DARK REPORT will conduct the webinar “FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do.”

ADD TO: LDTs

Speaking at the webinar on FDA regulation of LDTs will be Jane Pine Wood and Richard Cooper, attorneys with McDonald Hopkins; and Kuo Tong, CEO of Quorum Consulting of San Francisco. All three have experience working with the FDA to obtain clearance for medical devices, in vitro diagnostic tests, and specialty LDTs. Among other recommendations, they advise labs with LDTs that it would be timely to gather clinical data now in order to be ready to beat the rush of labs expected to file applications with the FDA once the LDT regulations are finalized and take effect at a date in the near future. Webinar details can be accessed at www.darkdaily.com.

Dark Daily Update

dark_daily_logoHave you caught the latest e-briefings from DARK Daily? If so, then you’d know about…

 

…the top 10 rankings of EHR market share in the hospital and ambulatory markets. Epic is number one on both lists. Just 10 EHR products control

90% of the hospital market, while the top 10 EHRs in the ambulatory market hold a market share of only 65%.

You can get the free DARK Daily e-briefings by signing up at www.darkdaily.com.

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