FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns

A little-known rulemaking proceeding is underway at the U.S. Copyright Office which, depending upon the outcome, may have profoundly favorable implications for the use by servicers of electronic medical device equipment manuals. Every three years under the Digital Millennium Copyright Act (“DMCA”), the Librarian of Congress, upon receipt of the recommendation of the Register of [...]

FDA Remanufacturing Guidance Comment Period Extended

On June 24, 2021, the FDA released a draft version of the FDA Remanufacturing Guidance. At the request of industry, the time frame for providing written comments to the guidance has been extended to September 22, 2021. In 2018, the agency disseminated a remanufacturing white paper, and now the circulation of a draft guidance indicates [...]

By |2021-08-05T21:07:51+00:00August 5th, 2021|Business, Government, Healthcare|0 Comments

Brexit agreement begins now: Are you ready?

By Robert J. Kerwin It was four years ago that Britain’s then-prime minister, David Cameron, set a referendum on  the U.K.’s continued membership in the European Union. In June 2016, the citizens of the U.K.  voted to leave the EU.  In January 2020, the U.K. officially withdrew, and since that time the EU and the [...]

By |2021-01-06T03:54:31+00:00January 6th, 2021|Business, Government, Healthcare|0 Comments

Predicting Growth in Ultrasound Markets—Six Predictions

With healthcare costs continuing to rise, affordable and accurate imaging and diagnosis achieved through ultrasound will continue to attract patients, according to a new market report from Fact.MR. The report on the global market for ultrasound systems projects steady growth for the market from 2017 to 2022, from a value of $6 billion in 2017 [...]

By |2019-05-02T14:22:18+00:00May 2nd, 2019|Business|0 Comments

AHA calls on hospitals, health systems to compete with ‘disruptors’

In a recent speech, Richard Pollack, President and CEO of the American Hospital Association noted that new entrants into the healthcare sector, such as Amazon, Apple and Google, are poised to serve as “disruptors” in the industry.  “We are seeing historic—if not unprecedented—change across the entire healthcare landscape,” Pollack told an AHA forum in Washington. “There’s no [...]

By |2019-03-26T10:00:15+00:00March 26th, 2019|Business|0 Comments

Philips kicks off new year with realigned business segments

When speaking about the growth of the Image-Guided Therapy businesses, Frans van Houten, CEO of Royal Philips, said in a statement. “To strengthen our leadership in this fast-growing market, we have significantly invested in our R&D programs, which resulted in the launch of the very successful Azurion next-generation image-guided therapy platform, and the acquisitions of Volcano, [...]

By |2019-01-17T12:38:09+00:00January 17th, 2019|Business|0 Comments

Cybersecurity–How To Stop (Or Slow) Hackers

The healthcare seems less concerned about hackers and more about achieving the tenets of value-based medicine. Its focus on improving patient experience and reducing cost has pushed cybersecurity down the list of spending priorities when it should be rising.  The healthcare industry must be prepared for hack attacks, cybersecurity experts agree. The very essence of value-based [...]

By |2018-10-11T13:24:23+00:00October 11th, 2018|Business|0 Comments
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