T2 Biosystems Inc. (NSDQ:TTOO) said today it filed a 510(k) appliation with the FDA for its T2Bateria Panel rapid diagnostic solution designed to identify pathogens assocaited with Sepsis. The T2Bacteria panel is designed to run on the FDA-cleared T2Dx instrument to provide diagnosis of sepsis pathogens within hours, reducing the time for patients with bloodstream infections […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Pulse Biosciences pulls, plans to refile FDA 510(k) clearance bid for PulseTx nanostim
Pulse Biosciences (NSDQ:PLSE) said today it withdrew its FDA 510(k) application for its PulseTX nano-pulse stimulation platform, but said it has plans to resubmit the application “in the coming months.” The Burlingame, Calif.-based company’s PulseTx system uses short-duration electrical pulses directed at solid tumors to induce immunogenic cell death. The cell death process exposes the tumor […]
Report: Abbott still looking to pull Xience DES from Indian market
Abbott (NYSE:ABT) is still looking to pull its Xience Alpine drug-eluting stent from the Indian marketplace after the country’s regulatory body set significant price caps on stents earlier this year, according to an Indian Economic Times report. The company reportedly approached India’s National Pharmaceutical Pricing Authority looking to withdraw the Xience stent yet again due to […]
Gecko Biomedical wins CE Mark for Setalum vascular sealant
Gecko Biomedical said today it won CE Mark approval in the European Union for its Setalum Sealant designed for use during vascular surgery. The Paris-based company said Setalum is a biocompatible, bioresorbable sealant designed as an add-on to sutures, and is usable in wet and dynamic environments and activated using a light activation pen. The […]
Medtronic recalls insulin infusion sets
Medtronic (NYSE:MDT) said today that it’s recalling some of the infusion sets used with its insulin pumps due to problems with a discontinued component. The Fridley, Minn.-based medical device titan said the problem involves a vent membrane that’s susceptible to blockage during priming and fill-tubing. No pumps or glucose sensors are affected by the recall, Medtronic […]
FDA releases hurricane disaster medical device safety guidelines
In the wake of multiple hurricanes making landfall in the US, the FDA released guidelines for maintaining medical device safety in natural disasters, warning of issues with fluctuating power, unusual levels of water, humidity and contaminants. The federal watchdog instructed users of medical devices to first and foremost keep the devices clean and dry and […]
7 medtech stories we missed this week: Sept. 8, 2017
From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating […]
China’s FDA releases revised medical device classifications
Late last month, the Chinese Food and Drug Administration announced a number of changes to medical device classifications, revising criteria and categories and reducing the risk level of 40 different categories of products, according to China Med Device. In the update, the CFDA added more than 5,000 product name examples, bringing the total up to […]
Japan approves Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfar for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The […]
FDA releases final guidance on medical device interoperability
The FDA this week released final guidance on interoperability in medical devices as more and more healthcare related electronics connect to the Internet of Things. “As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange information and use information that […]
ClaroNav wins FDA 510(k) for NaviENT surgical navigation system
Canadian medical device company ClaroNav said yesterday it won FDA 510(k) clearance for its NaviENT surgical navigation system designed for endoscopic sinus surgery and skull base surgery, with plans to launch in the coming months. The NaviENT is designed as an image-guided surgical navigation system to help otolaryngology-specific surgeons identify anatomic structures in transnasal interventions […]