California's 23andMe has capitulated to the FDA, agreeing to regulators' demands to stop selling all health-related genetic tests while it submits them for a formal regulatory review.
Why do some device and diagnostics companies nail down venture funding and advance their product development when others fail?
While some may want to credit alchemy, there are more tangible things involved. Shrewd management, timing, novel technology poised to boost the standard of care, and maybe even a little bit of luck can make the difference between success and failure in the startup world.
Believe us when we tell you this: The 15 fiercest medical device and diagnostics companies of 2013 rival our first annual roundup from 2012 in terms of innovation, drive and market-changing technology.
This year's winners include a company that concocted a blood test to help spot autism earlier in children. Another developed a new device to fight obesity in a novel way, and a third came up with a novel ultrasound device to treat uterine fibroids. A fourth--a molecular diagnostics company with an extremely sensitive and precise thyroid cancer test--filed IPO plans a few weeks before this special report came out. That company's likely advance to the public market reflects a confidence about the game-changing ability of its new test, the market potential of other technology in its pipeline, and an educated guess that investors will want a piece of the action once it goes public. Read the full report >>
Teva board agrees with CEO Jeremy Levin's decision to step down
Teva Pharmaceutical Industries ($TEVA) has agreed with Dr. Jeremy Levin that he will step down as president and CEO of the company. The move came amid last week's layoff announcement and an apparent clash between Levin and Teva's board of directors. More
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Jarvik Heart won Japanese regulatory approval for its left ventricular assist device, bringing its heart pump rivalry with Thoratec to Asia. Japan's Pharmaceuticals and Medicines Devices Agency signed off on the Jarvik 2000 Heart based on Japanese and U.S. clinical trial data, approving it as a bridge to transplant.
The FDA backs a market that lets consumers easily gain information about their genomes and genetic risks, an agency official said, despite its move to stop 23andMe from selling its direct-to-consumer health-related genetic tests until they obtain formal regulatory approval.
Boston Children's Hospital spinout Claritas Genomics, a genetic diagnostic testing company, attracted an investment from IT specialist Cerner, and the two will collaborate to develop a computing infrastructure designed to smooth the diagnostic process from start to finish.
Switzerland's Biocartis will link up with Belgium's VIB research institute to develop a diagnostic test useful for colorectal and other cancers, the company said.
Medtronic is touting stellar 7-year postmarketing patient results for one of its key artificial disc implants designed to treat degenerative spinal conditions. Researchers presented the data at a major conference--a shot of good news for the Minnesota company's struggling spinal division.
Notching another CE mark in its cardiac cache, Italian devicemaker Sorin nabbed European approval for its Intensia family of implantable cardiac defibrillator and cardiac resynchronization therapy devices.
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DioGenix is expanding the scope of a crucial clinical trial for a multiple sclerosis genetic test that could drastically reduce misdiagnosis of the degenerative disease. President and CEO Larry Tiffany told FierceDiagnostics that $3.2 million in new financing will help bring what has arguably become the largest trial of its kind in MS to completion through 2014.
The FDA late Friday approved Sovaldi, a highly anticipated hepatitis C drug from Gilead Sciences that is expected to change the face of treatment for the difficult condition while earning up to $7 billion a year for the company.