How Well Did You Follow Medtech News In 2013?

1. Which company got slapped on the wrist by the FDA for marketing a genetic test without a proper regulatory clearance?

23andMe

Myriad Genetics

I-Gene

Proteus Biomedical

23andMe is the correct answer because they were reprimanded by the FDA for promoting and selling a genetic test without obtaining the necessary regulatory clearance. The FDA expressed concerns about the accuracy and reliability of the test results, as well as the potential for the test to provide false positives or negatives for certain health conditions. As a result, 23andMe was instructed to stop marketing the test until they could provide sufficient evidence of its effectiveness and safety.

Explanation

23andMe is the correct answer because they were reprimanded by the FDA for promoting and selling a genetic test without obtaining the necessary regulatory clearance. The FDA expressed concerns about the accuracy and reliability of the test results, as well as the potential for the test to provide false positives or negatives for certain health conditions. As a result, 23andMe was instructed to stop marketing the test until they could provide sufficient evidence of its effectiveness and safety.

2. Under FDA's final guidance on mobile medical apps, which of the following would be regulated as a device

MyFitnessPal calorie counter and diet tracker

Glooko logbook for diabetes patients

AliveCor, which makes a iPhone ECG device and app

DrawMD series of apps that allow surgeons to draw surgical procedures for patients

AliveCor, which makes an iPhone ECG device and app, would be regulated as a device because it is used for medical purposes and falls under the definition of a mobile medical app according to FDA's final guidance. The app is designed to monitor and record electrocardiogram (ECG) data, which is a medical diagnostic tool used to detect and monitor heart conditions. Therefore, it meets the criteria for regulation as a medical device under FDA guidelines.

Explanation

AliveCor, which makes an iPhone ECG device and app, would be regulated as a device because it is used for medical purposes and falls under the definition of a mobile medical app according to FDA's final guidance. The app is designed to monitor and record electrocardiogram (ECG) data, which is a medical diagnostic tool used to detect and monitor heart conditions. Therefore, it meets the criteria for regulation as a medical device under FDA guidelines.

3. A U.S. medtech executive was held hostage by employees in a foreign location over a wage dispute. In which country did this occur?

Indonesia

China

Turkey

Israel

The correct answer is China because the question states that the medtech executive was held hostage by employees in a foreign location, and out of the given options, China is the only country mentioned that could be considered a foreign location for a U.S. medtech executive.

Explanation

The correct answer is China because the question states that the medtech executive was held hostage by employees in a foreign location, and out of the given options, China is the only country mentioned that could be considered a foreign location for a U.S. medtech executive.

4. Angelina Jolie shocked and amazed the world by publicly talking about her preventive double mastectomy after undergoing a genetic diagnostic test for breast cancer. Which company makes that test?

Abbott Labs

DiagnoCure

Siemens Healthcare Diagnostics

Myriad Genetics

Myriad Genetics is the company that makes the genetic diagnostic test for breast cancer that Angelina Jolie underwent. This test is known as the BRCA gene test, which looks for mutations in the BRCA1 and BRCA2 genes that are associated with an increased risk of developing breast and ovarian cancer. By publicly discussing her experience with the test and her decision to undergo a preventive double mastectomy, Angelina Jolie brought attention to the importance of genetic testing and raised awareness about options for managing breast cancer risk.

Explanation

Myriad Genetics is the company that makes the genetic diagnostic test for breast cancer that Angelina Jolie underwent. This test is known as the BRCA gene test, which looks for mutations in the BRCA1 and BRCA2 genes that are associated with an increased risk of developing breast and ovarian cancer. By publicly discussing her experience with the test and her decision to undergo a preventive double mastectomy, Angelina Jolie brought attention to the importance of genetic testing and raised awareness about options for managing breast cancer risk.

5. What company received FDA approval for the world's first bionic eye in 2013? Hint: It was also named MD+DI's Medical Device Manufacturer of the Year.

Olympus

Bausch & Lomb

Second Sight Medical Products

Advanced Bionics

Second Sight Medical Products received FDA approval for the world's first bionic eye in 2013. This company was also named MD+DI's Medical Device Manufacturer of the Year.

Explanation

Second Sight Medical Products received FDA approval for the world's first bionic eye in 2013. This company was also named MD+DI's Medical Device Manufacturer of the Year.

6. Which multinational got caught in a bribery scandal in China?

Pfizer

Novartis

Merck

GlaxoSmithKline

GlaxoSmithKline is the correct answer because they were indeed involved in a bribery scandal in China. In 2014, Chinese authorities accused GlaxoSmithKline of bribing doctors, hospitals, and government officials to increase sales and prices of their pharmaceutical products. The scandal resulted in a hefty fine of $490 million for the company and several employees being arrested and sentenced.

Explanation

GlaxoSmithKline is the correct answer because they were indeed involved in a bribery scandal in China. In 2014, Chinese authorities accused GlaxoSmithKline of bribing doctors, hospitals, and government officials to increase sales and prices of their pharmaceutical products. The scandal resulted in a hefty fine of $490 million for the company and several employees being arrested and sentenced.

7. Which of these transactions represents the largest medtech M&A in 2013?

Thermo Fisher Scientific’s purchase of Life science Technologies Corp., a leading producer of biotech and genetic testing equipment

Medtronic’s purchase of remote patient monitoring firm Cardiocom

St. Jude’s acquisition of Nanostim, developer of the first commercially available leadless pacemaker

Stryker's purchase of MAKO Surgical, a maker of robotically-assisted surgical products

Thermo Fisher Scientific's purchase of Life Science Technologies Corp. represents the largest medtech M&A in 2013 because it involves the acquisition of a leading producer of biotech and genetic testing equipment. This suggests a significant investment and consolidation of resources in the field of medical technology, making it the most substantial transaction among the options provided.

Explanation

Thermo Fisher Scientific's purchase of Life Science Technologies Corp. represents the largest medtech M&A in 2013 because it involves the acquisition of a leading producer of biotech and genetic testing equipment. This suggests a significant investment and consolidation of resources in the field of medical technology, making it the most substantial transaction among the options provided.

8. Two U.S. companies have been battling it out against each other for years to gain an edge in the structural heart market. This year, a European court temporarily forced one company to pull its product handing a brief victory to the other. Which are those companies

Edwards Lifesciences and St. Jude Medical

St. Jude Medical and Boston Scientific

Medtronic and Edwards Lifesciences

Medtronic and Boston Scientific

The question states that two U.S. companies have been competing in the structural heart market, and this year, a European court temporarily forced one company to withdraw its product, giving a temporary advantage to the other company. The correct answer is Medtronic and Edwards Lifesciences, as they are the only option that includes both of these companies.

Explanation

The question states that two U.S. companies have been competing in the structural heart market, and this year, a European court temporarily forced one company to withdraw its product, giving a temporary advantage to the other company. The correct answer is Medtronic and Edwards Lifesciences, as they are the only option that includes both of these companies.

9. Last year, GSK made history by agreeing to pay the Department of Justice $3 billion to settle healthcare fraud charges. This year Johnson & Johnson had its own billion-dollar settlement. How large was it?

$2.2 billion

$1.8 billion

$2.7 billion

$2.4 billion

Johnson & Johnson's billion-dollar settlement was $2.2 billion.

Explanation

Johnson & Johnson's billion-dollar settlement was $2.2 billion.

10. Which of these mobile health companies broke crowdfunding records on the Indiegogo crowdfunding site by raising $1.6 million from scores of small donors online?

AliveCor, which makes a iPhone ECG device and app

Audax Health, which is building a gaming/rewards platform to help people make healthy choices

FitBit, which makes sensors to track physical activity

Scanadu, which is using mobile and sensor technology to make the world's first medical tricorder

Scanadu broke crowdfunding records on Indiegogo by raising $1.6 million from small online donors. They are using mobile and sensor technology to develop the world's first medical tricorder.

Explanation

Scanadu broke crowdfunding records on Indiegogo by raising $1.6 million from small online donors. They are using mobile and sensor technology to develop the world's first medical tricorder.