A look a the benefits and risks of commercial and open-source SDKs for DICOM software.

Andrew Dallas

There are risks and advantages to open-source software in general relative to its commercial counterparts. Notable open-source success stories in the medical and scientific domains are the ITK and the VTK. Factors for their success include the following:

  • Targeting of a specialized and valuable domain.
  • Licensing that allows use in commercial products.
  • Adoption by the business community with its commensurate support.

Digital Imaging and Communications in Medicine (DICOM) software has a relatively long history in the open-source community, largely in response to the cost...

June 17th, 2015
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OtisMed—More than $80 million

In December 2014, OtisMed Corporation agreed to pay more than $80 million after acknowledging that the company and its ex-CEO knowingly sold surgical cutting guides for knee replacements even though FDA had denied regulatory approval. According to the DOJ, OtisMed pled guilty to violating the Food, Drug, and Cosmetic Act. The penalty included a $34.4 million criminal fine and a $5.16 million criminal forfeiture, according to the release. The company also agreed to pay a $40 million plus interest fine to settle the civil allegation. 

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June 17th, 2015
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Bio-Rad Laboratories—$55 million

Bio-Rad Laboratories Inc., a company selling research equipment and diagnostics products, was charged in November 2014 with bribing officials in Russia, Vietnam, and Thailand and ordered to pay a total fine of $55 million. According to the SEC, this included a $40.7 million in disgorgement to the SEC and a $14.35 million DOJ criminal fine. 

The SEC claimed that Bio-Rad Laboratories didn't have proper internal controls in place to prohibit or catch bribes totalling approximately $7.5 million over five years. Bio-Rad made $35 million in profits from these bribes. The company was...

June 17th, 2015
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Health Diagnostics Laboratory—$47 million

Health Diagnostics Laboratory Inc., a provider of diagnostic testing, agreed in April 2015 to pay a $47 million fine to settle allegations of kickback payments and billing for unnecessary testing. According to the DOJ, Health Diagnostics Laboratory and two other labs allegedly paid doctors for patient referrals and also received patient referrals for unnecessary tests that were billed to government programs like Medicare.  

The case was examined by numerous goverment agencies, including DOJ's Civil Division, the U.S....

June 17th, 2015
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CareFusion—$40.1 million

CareFusion Corporation, makers and sellers of various types of medical products, agreed in January 2014 to pay a $40.1 million fine to settle allegations that the company paid kickbacks and encouraged off-label use of its ChloraPrep products.

According to the DOJ, the allegations claimed that CareFusion paid kickbacks of $11.6 million to a doctor who was then the co-chair of the Safe Practices Committee at the National Quality Forum, in order to secure that doctor's endorsement of ChloraPrep. In addition, the company also allegedly recommended...

June 17th, 2015
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ArthroCare—$30 million

ArthroCare Corporation, a company selling arthroscopic surgery and sports medicine devices, was ordered to pay a $30 million fine in January 2014, according to the Department of Justice (DOJ). In a case that was examined by FBI and SEC, the penalty was exacted to settle charges that top executives at ArthroCare allegedly defrauded shareholders of more than $400 million.  

According to the DOJ, ArthroCare conceded that executives lied about the company's revenue and importance of its distributor relationships. The company also admitted that the executives had company...

June 17th, 2015
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Some medtech companies have paid a hefty price for alleged bad behavior. Here are the five highest fines of 2014 and 2015 (so far).

Most medtech companies do a lot of good, developing and selling medical devices and diagnostics that save patient lives. But a few companies have reportedly run afoul of the law—bribery, selling without regulatory approval, and securities fraud, to name a few allegations. 

These companies have been investigated and have paid monetary penalties. Here are the 5 highest fines paid by medtech companies in 2014 and the first half of 2015.

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June 17th, 2015
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Envisioning a future where humans are vulnerable to e-viruses from their implantable medical devices and diagnostics.

Dinesh Peter, Nandini Diwakar, and Avijit Dutta

Here’s a strange tale: While wrapping up his post-lunch meeting, Ted starts feeling severe abdominal cramps accompanied by prolonged bouts of shivering. Having no recollection of doing or eating anything unusual recently, and unable to explain his symptoms, Ted drives to the nearest hospital to get examined before his symptoms become more serious.

“Ted Lewis,” Dr. Lisa calls out as he waits for his turn at the ER. In the examination room, Ted explains his condition to Dr. Lisa. She checks his vitals and orders a blood test and an ultrasound examination. During the ultrasound, simethicone is...

June 17th, 2015
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Medical sales is known as a lucrative profession, but even within sales, some representatives get paid more than others. Find out what an annual salary report says is the best-paid category of medical sales.

Marie Thibault

Selling medical products is a big business and one that pays well too—after all, sales manager is one of the highest paying jobs in medtech. But, as with any job, there are some sales representatives who are better compensated than others. The MedReps.com 2015 Medical Sales Salary Report breaks down medical sales rep incomes by several characteristics, including product category, age...

June 16th, 2015
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Exhibitors at MD&M East and Atlantic Design & Manufacturing showed off some exciting medical applications for 3-D printing.

From prototyping to volume manufacturing, prostheses to implants, 3-D printing is opening up a new world for medical device designers.

At last week's MD&M East and Atlantic Design & Manufacturing shows in New York City, a number of medical applications of 3-D printing were on display.

 

 

 

Formlabs, maker of the Form1+ desktop 3-D printer, showed off an...

June 15th, 2015
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