The FDA is readying a pilot program to try and improve the pre-market approval process for high-risk medical devices later this month. The federal safety watchdog is seeking nine companies to participate in its Premarket Approval Application Critical to Quality program beginning Sept. 29 and running to either Dec. 31, 2018, or until nine PMAs […]
Food & Drug Administration (FDA)
T2 Biosystems files 510(k) for T2Bacteria Panel
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 […]
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 […]
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 […]
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 […]
FDA details possible regulatory paths for Strata Sciences Optimal Dosing Tech
Strata Skin Sciences (NSDQ:SSKN) said this week it received a response letter from the FDA concerning possible 510(k) clearance paths for its Optimal Dosing Technology initially designed for treating psoriasis, vitiligo and other skin conditions. The Horsham, Penn.-based said the federal watchdog proposed 2 alternative paths, the 1st of which would require a clinical trial to […]
GE Healthcare wins FDA nod for mammography system with patient controlled compression
GE Healthcare (NYSE:GE) said yesterday it won FDA 510(k) clearance for its Senographe Pristina Dueta, which it claims is the 1st patient-assisted mammography device that allows women to control their own compression during the examination. With the system, the woman undergoing the exam can control the application of compression on their breasts to minimize perceived pain […]
NuVasive wins FDA nod for redesigned Magec system
NuVasive Inc. (NSDQ:NUVA) said today it won FDA 510(k) clearance for its redesigned Magec magnetically controlled growth modulation system. The San Diego, Calif.-based company’s Magec system uses magnetic technology and adjustable growth rods to treat early-onset scoliosis, and features the company’s Reline small stature system. The Reline small stature platform is a pediatric deformity fixation system which […]
Janssen’s respiratory panel wins 510(k) clearance
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen Diagnostics said today that it won 510(k) clearance from the FDA for its Idylla respiratory panel. The diagnostic test, developed in partnership with Biocartis Group, helps physicians identify viral respiratory infections, including infection from respiratory syncytial virus and influenza virus. Get the full story at our sister site, Drug Delivery […]