Med tech chalks up solid year of new device approvals in 2014

29 January 2015

Emily Wasserman / Firece Medical Devices

Medical device approvals continued at a steady clip in 2014 despite mounting pressure from lawmakers to roll out a more stringent review process. The FDA granted approvals for 33 innovative devices in 2014, up 43% over the number it OK'ed the year before, according to EP Vantage. FierceMedicalDevicescovered device approvals from the first half of the year in an earlier report.

Part of the explanation could be accelerated approvals, as the agency's review times for PMAs during the first half of 2014 rang in at 18.4 months--down from 35.9 months in 2013. But the agency also awarded innovation this past year, signing off on products that filled an unmet need or devices that could have an immediate benefit for patients.

Take DexCom's continuous glucose monitor: In February, the FDA gave the San Diego, CA-based company its blessing for a pediatric version of the device, allowing the product to be used in toddlers and heeding the call for more child-friendly devices. The approval paved the road for another win for the company, as in October, DexCom ($DXCM) got an FDA OK for an updated version of its G4 Platinum continuous glucose monitoring system that wirelessly transmits a patient's glucose levels and reports information through a smartphone.

Then, there was Exact Sciences' ($EXAS) win for its stool-based colorectal cancer test, a noninvasive tool that provides an alternative to traditional screening methods. The agency signed off on the product through a joint pilot program with the Centers for Medicare and Medicaid Services that reduces waiting times between approval and Medicare coverage. Exact's Cologuard test was the first product to take part in the initiative, and the company snagged full Medicare reimbursement a few months after FDA approval.

There were also a fair number of med tech regulatory showdowns in 2014, most notably between Medtronic ($MDT) and archival Edwards Lifesciences ($EW) over competing transcatheter heart valves, and C.R. Bard ($BCR) and Medtronic regarding drug-coated balloon catheters. In January 2014, Medtronic won early FDA approval for its CoreValve system, dealing a blow to Edwards in the companies' ongoing patent litigation over related products. But in June, Edwards struck back with approval for its Sapien XT heart valve, adding fuel to the fire and eyeing sales between $1.0 billion and $1.1 billion in 2015.

In November, Medtronic scored a point against C.R. Bard when the FDA greenlighted its IN.PACT Admiral drug-coated balloon catheter for patients with peripheral artery disease. C.R. Bard had already notched a regulatory win for its product in October, getting an FDA signoff for its Lutonix drug-coated balloon catheter. Both companies are chasing a drug-eluting balloon market that is projected to reach $600 million by fiscal year 2018, according to analyst estimates.

While the following list is not comprehensive, it covers the majority of devices that won the FDA's premarket approval in the second half of 2014, beginning at the end of May. As always, feel free to contact us with any comments or questions. 

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