A Closer Look at Medical Devices Approved in 2015


A great feature of the Devices & Diagnostics Edition of the PharmSource Lead Sheet is the option to find devices by medical specialty (therapeutic area). This makes it fast and easy to get the information you need.

The graphs and chart below show pre-market approvals (PMAs) in CY 2015, using data from the PharmSource Lead Sheet together with information from the FDA’s website.

In 2015, our analysts noted an increase in PMA approvals in H1, compared to H1 of 2014. We predicted a steep growth trend, and we were right! (Read more on our blog about this.) In 2015, there were a total of 43 PMA original approvals, a 72% increase from 25 approvals in 2014, and a 105% increase from 21 approvals in 2013 (Figure 1).

Figure 1: PMA original approvals in 2013, 2014 and 2015

Using data from the PharmSource Lead Sheet, we further broke down medical device approvals in 2015 by medical specialty/therapeutic area. Figure 2 below shows all the medical specialties/therapeutic areas that received PMA approvals during this period (note that there may be multiple therapeutic areas for one device).

Figure 2: PMA approvals by the medical specialty/therapeutic area of the device

Figure 3: A break-down of each therapeutic area shown in Figure 2

Approximately one third of 2015 PMA approvals were for cardiovascular/vascular devices. The cardiovascular/vascular medical specialty has had the highest number of PMA approvals for the past few years. In 2013, eight cardiovascular/vascular devices received a PMA approval, which accounted for 38% of total PMA approvals that year. In 2014, a total of ten cardiovascular/vascular devices were approved, which accounted for 40% of total PMA approvals that year. If the trend is consistent, we can expect to see a higher number of cardiovascular/vascular devices receiving PMA approvals, compared to other therapeutic areas.

We expect to see an increase in the total number of PMA approvals in 2016. The FDA has also been increasing its efforts to shorten device approval times, and implementing changes to allow device companies to have an open dialogue about their products and regulatory steps to take in order to bring them to market.

Recently, the medical device excise tax was suspended for two years. This may increase activity in medical device development, especially for companies that were negatively affected by the 2.3% excise tax.

For more information on PharmSource’s coverage of medical devices and diagnostics, please contact our business development manager, Nathaniel Celentano: nathaniel@pharmsource.com | +1-703-383-4903 x112.

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Judy Nanthavong is a Senior Research Analyst at PharmSource, and specializes in covering events related to medical devices and diagnostics. Prior to joining the company as a full-time, permanent staff member, she previously worked here as a student intern. Judy holds a BS degree in Health Science, Health Systems Management from George Mason University.

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