2015 medtech approvals rocket


It’s official – 2015 saw the greatest number of novel US medtech approvals in a decade. The FDA granted a total of 51 first-time premarket approvals and humanitarian device exemptions, just shy of the 52 forecast at the half-year point and well above the 33 in 2014 (see tables below).

The expedited access PMA route, which kicked in in April, seems yet to have an impact – the average time to approval was roughly the same as 2014. But the FDA is saying yes to more devices than ever, and the number and speed of approvals should only increase if the 21st Century Cures bill comes into effect.

This might provide a glimmer of hope to smaller medtech players that are finding it tough to get funding, both from venture capitalists and on the public markets. Investors appear increasingly keen on revenue-generating companies, reflected in a shift towards larger, later-stage funding rounds and IPOs (The medtech IPO window swings shut, January 21, 2016). 

If approval is indeed getting easier, companies have a better chance of making it to this stage and, in turn, attracting investment or perhaps a buyer. However it is usually the bigger players that manage to make it over this hurdle.

Cardiology still on top

Of course, some sectors fare better than others when it comes to attracting dollars – and some also bag the lion’s share of approvals. As in 2014, the cardiology and in vitro diagnostic (IVD) segments had the most approvals in 2015, while orthopaedics and neurology were also popular.

Gastroenterology, where there were no approvals in 2013 or ’14, had three last year, two of these for gastric balloons. This is likely to be a growing sector as the obesity epidemic continues.

And cardiology approvals were even faster, on average, than they were in the first half of the year – which was already speedy (2015 could see most device approvals for a decade, July 29, 2015). 

But this was not the quickest sector by a long shot. That honour went to diabetes, which admittedly only had two approvals. One was for Medtronic’s Paradigm Real-Time Revel system, an insulin pump that incorporates continuous glucose monitoring technology, which got the nod in just 5.9 months.

The fastest approval of all was for Dako/Agilent Technologies’ test for PD-L1 expression, a companion diagnostic for Bristol-Myers Squibb’s Opdivo and Merck & Co’s Keytruda in non-small cell lung cancer. The FDA waved it through in just three months. However, the role of PD-L1 testing with checkpoint inhibitors remains controversial and uptake looks likely to be slow.


HDEs are usually quicker than PMAs, as they address rare diseases with few existing options. But this was not necessarily the case in 2015, with the tardiest approval being an HDE for Integrum’s OPRA osseo-anchored prostheses for amputees, which took more than six and a half years. The second longest approval was for Wright Medical’s troubled Augment bone graft, which finally got its PMA after five and a half years.

Removing these two outliers from the analysis brought the average approval time for PMAs and HDEs down to 14.6 months.

Average review times for PMAs and HDEs by therapy area (months)
EvaluateMedTech device classification First PMAs in 2013 Avg review time in 2013 First PMAs in 2014 Avg review time in 2014 First PMAs in 2015 Avg review time in 2015*
Anaesthesia & respiratory 1 61.3 2 18.5 - -
Blood 1 13.2 2 8.7 - -
Cardiology 7 17.1 11 12.9 15 13.9
Diabetic care 1 15.7 1 19.0 2 9.8
Diagnostic imaging 1 16.8 1 13.0 2 11.5
Ear, nose & throat - - 1 9.5 - -
Gastroenterology - - - - 3 14.0
General & plastic surgery 3 68.2 1 28.7 - -
In vitro diagnostics 4 8.6 9 13.3 12 11.3
Nephrology - - - - 1 25.1
Neurology 1 40.5 1 8.9 5 19.3
Obstetrics & Gynaecology - - - - 1 12.5
Ophthalmics 1 21.4 1 11.0 1 28.1
Orthopaedics 2 30.0 3 48.0 6 24.5
Physical medicine - - - - 1 80.9
Urology - - - - 1 29.2
Wound management 1 31.2 - - 1 14.7
Total 23 - 33 - 51 -
Average - 26.9 - 16.7 - 17.0
*This analysis excludes approvals for which review time is not yet available.       

As expected, the de novo clearance route was even faster during 2015, with 18 approvals taking an average of 10.9 months.

This pathway, introduced in 2014, is for low-risk devices that would usually be approved via the 510(k) route but are too dissimilar to prior technologies to be able to use a predicate (The FDA's latest push to speed medtech approvals, August 28, 2014). 

The fastest de novo approval remains that for DexCom’s Share Direct Secondary Displays apps for blood glucose monitoring in diabetes, which got the go-ahead in just 1.3 months.

De novo 510(k) clearances granted by the FDA in the second half of 2015
Device name Company EvaluateMedTech Classification – L1  Number Decision date Review time (months)
Earlens Contact Hearing Device EarLens Ear, Nose & Throat DEN150002 September 29 8.9
Filmarray Meningitis/ Encephalitis Panel bioMerieux In Vitro Diagnostics DEN150013 October 8 6.0
Sonablate 450 SonaCare Medical Urology DEN150011 October 9 6.6
Invocell INVO Bioscience Unclassified DEN150008 November 2 8.3
Relizorb Alcresta Gastroenterology DEN150001 November 20 10.6
Dignitana AB Dignicap System Dignitana General & Plastic Surgery DEN150010 December 8 9.1
Newa Skin Therapy System EndyMed General & Plastic Surgery DEN150005 December 18 11.0
CNEP Airway Sommetrics Anesthesia & Respiratory DEN140024 December 23 16.2

To contact the writers of this story email Elizabeth Cairns or Madeleine Armstrong in London atnews@epvantage.com or follow @LizEPVantage or @medtech_ma on Twitter

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