MASSDEVICE ON CALL — The FDA’s inital review of rejected applications deemed "Not Substantially Equivalent" found that nearly 80 percent of the rejections cited insufficient performance data, sometimes despite repeated FDA requests.
NSE determinations made up 3.5 percent of decisions on 510(k) applications between 2001 and 20010, and rose sharply to 8 percent in 2010. The rate decreased to 5 percent for the first eight months of fiscal year 2011.
Other NSE decisions were made based on lack of a suitable predicate, intended use different from that of the predicate device and new technology not substantially equivalent to existing technology. The findings stem from an internal audit by the FDA’s medical device arm, the Center for Devices & Radiological Health.
"Although NSE determinations represent a small percentage of all 510(k) decisions, they utilize a greater amount of FDA time and resources than the average 510(k)," according to the audit.
Uncertainty about the 510(k) process, by which the vast majority of medical devices are cleared for the U.S. market, was the leading factor in pushing new device introductions overseas, according to a survey published by Northwestern University last month.
More changes afoot for Covidien?
Aside from news of a significant re-tooling of the executive suite at Covidien plc (NYSE:COV), broken by MassDevice last night, the company is also looking to ditch its pharmaceuticals division.
The Mansfield, Mass.-based medical products maker hired JPMorgan Chase & Co. (NYSE:JPM) to broker a deal, an un-named source told the Bloomberg new service, after a deal with another health care giant fell through.
But if the bids don’t top Covidien’s rumored $4 billion price tag, it could opt to hold on to its drugs business, according to the un-named source.
Spinal Modulation pulls down $30 million in Series D round
Spinal Modulation Inc., a Menlo, Calif-based firm that’s developing an implantable spinal cord stimulator to manage chronic pain, drummed up $30 million in a Series D funding round that drew Medtronic Inc. (NYSE:MDT) into its roster of backers.
Medtronic, the world’s largest pure-player medical device maker, joined existing investors DeNovo Ventures, ePlanet/DFJ, InCube Ventures, Johnson & Johnson Development Corp., Kleiner Perkins Caufield & Byers, MedVenture Associates and Raffles Venture Partners in the round, according to a press release.
"I am very pleased to have Medtronic join our current investors in this round of financing. We are encouraged by the early clinical results with our fully implantable system and look forward to providing physicians new options to care for their patients suffering from chronic pain," president & CEO David Wood said in prepared remarks.
QAL Medical buys Otto Bock’s continuous passive motion business
QAL Medical LLC plans to move part of Otto Bock’s continuous passive motion business south of the border after acquiring the unit for an undisclosed amount.
The Marinette, Wis.-based company is moving Otto Bock’s manufacturing and services operations to its home town, creating 15 new jobs there, according to the Green Bay Gazette.
The devices are used to help patients rehabilitate after traumas or surgeries affecting joints, such as knee replacements.
Hybrid ORs coming to a hospital near you
Hybrid operating rooms that combine surgical suites with the latest in high-tech imaging equipment are becoming more and more popular, according to one research firm that pegs the hybrid OR market as a major driver for the $2.4 billion U.S. imaging market.
"These hybrid ORs are leading to a lot of interesting strategic alliances between major companies that have never worked closely together before," according to Millenium Research Group analyst Kai Tuomi. "Operating room integration competitors, such as STERIS, Skytron and Stryker, are working closely with companies that produce high-end imaging systems or surgical robotics, such as GE Healthcare, Siemens and Intuitive Surgical. Each alliance provides a unique combination of equipment, but all support advanced surgical techniques for complex cases, while also increasing patient safety."
Three hybrid OR suites are competing, according to MRG:
- GE Healthcare (NYSE:GE) and Steris Corp. (NYSE:STE) combine GE’s Innova Imaging System with the STERIS HD 360° Suite in customized room setups;
- Stryker Corp. (NYSE:SYK) and Intuitive Surgical (NSDQ:ISRG) have an agreement that will place the daVinci Si surgical robot into the Stryker iSuite;
- Skytron and Siemens (NYSE:SI) will combine efforts to provide direct competition to the Steris/GE Healthcare offering.