Johnson & Johnson's DePuy Synthes unit is facing regulators' ire as the FDA slapped the company's recall of its jaw-stabilizing device with a Class I label, its most serious designation.
In 2013, a number of outside forces hammered the med tech industry. While things could have been better, most of the top 10 companies in the sector still enjoyed moderate year-over-year revenue gains.
Plenty of obstacles limited those positive results, however.
Over the past two decades, 3-D printing has grown from a niche technology to a multibillion-dollar industry. The manufacturing process was developed in the 1980s as a way to produce small volumes of scale models but has since expanded to include the manufacturing of medical devices and implants for surgical and clinical use. The process, also known as additive manufacturing, uses computer models to build three-dimensional objects by printing materials like plastic, polymers, metals and powders in layers.
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Johnson & Johnson is reportedly seeking a buyer for its Cordis unit, which is focused on vascular medical devices. This would be the second major divestiture for the conglomerate this year, it sold Ortho-Clinical Diagnostics to private equity firm The Carlyle Group in June for $4.2 billion.
Pediatric devices are in short supply because of the prevalence of rare diseases in children, as well as their unique physiology. So, FDA's 510(k) clearance of Medtronic's Shillla Growth Guidance System for the treatment of scoliosis in children less than 10 years old has particular significance.
Researchers used transcranial magnetic stimulation to stimulate the hippocampus region in the brain. This resulted in increased connectivity in related regions and improved memory that persisted in healthy volunteers for more than 24 hours after stimulation, according to a study in the latest issue of the journal Science.
Fresh off the sales of its interventional device unit to Boston Scientific, Bayer Healthcare is showing renewed interest in med tech via its startup accelerator.
Brain surgeons have long relied on a pathology analysis to determine if they have completely removed a tumor. This can be a time-consuming and inaccurate process. Results of a study for a new imaging system that detects a molecular marker found in brain gliomas suggest it could improve upon that surgical practice.
The latest in a series of guidances explaining and implementing last year's Unique Device Identification final rule is "little more than a regurgitation of information contained in the rule itself, the preamble to the rule, the UDI website, and the Global Unique Device Identification (GUDID) guidance document," wrote medical device law attorney Jennifer Newberger.
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