Torax Medical said today that it won FDA approval for the next generation of its Linx reflux management system with MRI compatibility. The Linx system is an implant composed of interlinked titanium beads with magnetic cores that augments the esophageal sphincter’s barrier function to prevent reflux in patients with gastro-esophageal reflux disease, the St. Paul, […]
Implanted electrodes can help amputees gain sensation in prosthetics | MassDevice.com On Call
MASSDEVICE ON CALL — Swiss researchers have a developed a new prosthetic limb system that uses implanted electrodes to send sensory signals from the limb back to the brain, creating a more realistic sense of touch.
"We could be on the cusp of providing new and more effective clinical solutions to amputees in the next years," Silvestro Micera, head engineer at the École Polytechnique Fédérale de Lausanne Translational Neural Engineering Laboratory, said in prepared remarks.
Torax Medical raises $30M for acid reflux treatment devices
Torax Medical closed a $30 million Series D funding round in support of its acid reflux treatment products.
The funds will go toward expanding commercialization of the St. Paul, Minn.-based medical device company’s sphincter augmentation systems, including Torax’s platform Magnetic Sphincter Augmentation devices.
Vascular Nanotransfer Technologies taps new CEO
Zoll wins FDA nod for EMS AED | Regulatory Roundup
Zoll Medical (NSDQ:ZOLL) said it won 510(k) clearance from the for its ZOLL X monitor/defibrillator, a smaller, more powerful device aimed at the EMS market.
FDA approves first endovascular grafts for aortic tears | Regulatory Roundup
The FDA granted W.L. Gore & Associates the first U.S. clearance for using an endovascular graft to treat tears or ruptures in the aortic wall.
Gore’s Conformable TAG thoracic endoprosthesis was approved as a treatment for a transection or tear in the aortic wall, an injury typically the result of a car accident, crushing of the chest or a fall from a high place, according to an FDA release.
J&J’s Ethicon Endo-Surgery gets appeal date for Sedasys denial
Ethicon Endo-Surgery’s Sedasys system, which the agency declined to green-light in 2010, will go before an agency panel in December to plead for approval one more time.
The Johnson & Johnson (NYSE:JNJ) subsidiary is slated to appear before the FDA’s Medical Devices Dispute Resolution Panel to consider the FDA’s denial of the device on grounds that EES failed to prove Sedasys is safe enough for the U.S. market.
Diabetes: FDA clears t:slim portable pump and iglucose management system | Regulatory Roundup
Tandem Diabetes Care and PositiveID (OTC:PSID) landed FDA clearance for their t:slim portable insulin pump and iglucose diabetes management systems, respectively.
Torax Medical raises $4 million in quest for $8 million
Torax Medical raised $4 million by issuing debt and is seeking another $4 million in funding, according to a recent regulatory filing.
It appears that the Shoreview, Minn.-based company, which is focused on the minimally invasive treatment of gastroesophageal reflux disease, raised $18 million in 2009, $10 million in 2005 and another $3.5 million in 2004.
All three previous financing rounds were in exchange for equity.
Torax Medical wins CE Mark for GERD device
Torax Medical Inc. won CE Mark approval in the European Union for an implantable device that treats patients suffering from acid-reflux disease.
