The FDA issued a pair of Class II recall notices on Feb. 24 for the EndoWrist One Vessel Sealer. The agency said the device may "exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws."
The U.S. Food and Drug Administration is working to update the labels for duodenoscopes linked to the recent "superbug" outbreak that were inadequately cleaned, according to a Reuters report.
Boston Scientific sat out most rounds of med tech M&A the past few years, but the device giant might be charting a different course in 2015. The company is reportedly close to buying Endo International's AMS medical device unit in a deal estimated at $2 billion.
An Israeli company, Biop Medical, is developing the Biop diagnostic medical device to detect cervical cancer.
The Brookings Institution has just laid out its vision of a comprehensive medical device postmarket surveillance system in a report to various device industry stakeholders. The report's ideas were further detailed and debated during a series of moderated discussions at the think tank featuring the CEOs of Medtronic and Edwards Lifesciences, and the head of FDA's device arm, or CDRH.
Another startup from controversial med tech visionary Alfred Mann is making its way to the fore: Bioness. He founded the company in 2004. Now, Bioness has gained clearance from the FDA for its StimRouter, an implantable neuromodulator to treat chronic, intractable pain of peripheral nerve origin. It's the only implant cleared by FDA specifically for peripheral nerve stimulation.
Outsourced product design specialist TE Connectivity will increase its focus on medical devices with its $190 million purchase of catheter player AdvancedCath.
Johnson & Johnson is shelling out as much as $420 million to resolve claims over recalled hip implants, adding to its previous $2.5 billion settlement and laying more lawsuits in its ongoing courtroom battle to rest.
The FDA has warned that even if healthcare providers clean endoscopes according to manufacturer recommendations, a risk of infection still remains.
2014 is bound to go down as the year of med tech merger mania. FierceMedicalDevices compiles the year's 10 biggest medical device and diagnostic mergers.
Biotronik said at the Cardiovascular Research Technologies conference that its investigational Astron self-expanding nitinol stent for the narrowing of the leg's iliac or external arteries met its clinical endpoint, as the company chases FDA approval.
Teijin and Nakashima Holdings are joining forces to try to claim a bigger share of the Japanese medical device market. Teijin is acquiring half of Nakashima Medical, a subsidiary of Nakashima Holdings, for about ¥1.5 billion ($12.6 million) as of April 1.
HeartWare has issued a voluntary recall of some of its Ventricular Assist System Controllers due to their higher susceptibility to electrostatic discharge than some newer, commercial controllers. An electrostatic discharge can cause a pump to stop, which could result in serious injury or death.
Medtronic has just disclosed that it bought Advanced Uro-Solutions in December 2014 for an undisclosed amount. In August 2013, the FDA cleared the startup's neurostimulation device, the Nuro System, to treat overactive bladder and its associated symptoms of urinary urgency, urinary frequency and urge incontinence.
A deal that was rumored this summer now looks like it's ready to come to pass. Johnson & Johnson is ready to sell off its Cordis business to Cardinal Health for as much as $2 billion, according to report by Bloomberg. Cordis has elicited multiple offers from bidders, some of whom may still be in the running.
With the FDA approval of Covidien's VenaSeal closure system, medical professionals can for the first time treat varicose veins in the legs by using an adhesive to cut off blood supply.
An orthopedic advisory panel voted to approve Vertiflex's PMA application to the FDA for its Superion Interspinous Spacer, a spinal implant designed to treat moderate lumbar stenosis and pain, numbness and/or leg cramps related to the condition.
GE told FierceMedicalDevices in an email that the recall was voluntarily initiated following a single safety incident in India, where some users had disabled the so-called magnetic rundown unit, because the company "wanted to ensure that the human error was not occurring at other sites globally."
At least three med techs made this year's accounting by The Wall Street Journal estimating the most valuable private companies.
Bayer is slated to sell its diabetes devices business to Panasonic Healthcare, according to a report from Bloomberg. The move has been years in the making as Bayer works to sell off peripheral businesses to focus on its core profitable ones.