Robotic surgical software developer Medical Surgery Technologies said yesterday it won FDA 510(k) clearance for its Follow Me minimally invasive robotic surgery software. The Follow Me software is designed to enable image-guided laparoscopes to follow laparoscopic surgical tools without manual control, according to the company. “Securing FDA clearance for the Follow-Me software is a major […]
Food & Drug Administration (FDA)
FDA clears Glaukos Phase II iDose drug-eluting eye implant trial
Glaukos (NYSE:GKOS) said today it won a nod from the FDA for an investigational new drug Phase II study of its Travoprost intraocular implant utilizing the company’s iDose delivery system for patients with glaucoma. The iDose system is injected through a clear corneal incision and secured in the anterior chamber to continuously elute therapeutic levels of […]
NeuroMetrix jumps on next-gen Quell FDA nod, but can’t hold momentum
NeuroMetrix (NSDQ:NURO) saw shares jump as high as 37% yesterday after announcing it won FDA 510(k) clearance for an upgraded version of its Quell wearable over-the-counter chronic pain relief device, though shares haven’t held onto the inertia in trading today. The new model is designed to be controlled through a company-developed smartphone app, and has an […]
PA rep Fitzpatrick wants FDA to launch criminal probe into morcellator deaths
Rep. Mike Fitzpatrick (R-Pa.) wants the FDA to open a criminal investigation of several deaths associated with laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors. The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade […]
Ivenix taps ex-GI Dynamics chief Randle for CEO | Personnel Moves
Ivenix said in named former GI Dynamics (ASX:GID) chief Stuart Randle to be its new CEO. Randle departed GI Dynamics in August 2014, after 10 years with the bariatric device maker. Amesbury, Mass.-based Ivenix, which raised $42 million last September, is developing an infusion management system for hospitals that will combine an information technology interface […]
Medtech wins FDA nod for ROSA spine robot
French surgical robotics firm Medtech Innovative Surgical Technology said today it won FDA 510(k) clearance for its ROSA spine robot. The robot is designed to be used during minimally invasive spinal surgeries, though the ROSA platform is shared with its brain system, designed for brain surgery procedures. “We are thrilled to have FDA approval for […]
FDA warns Sorin on Stockert heater/cooler device
The FDA issued a warning letter late last month to Sorin Group (BIT:SRN) concerning issues with its Stockert Heater Cooler 3T thermal regulator devices. The agency hit the company for marketing the product as something other than a device, outside the FDA’s guidelines. The FDA said the company had responded to its original concerns after an […]
Brain cancer: NovoCure looks to get 2nd-gen Optune device on the U.S. market
NovoCure (NSDQ:NVCR) said today that it applied for a supplemental pre-market approval from the FDA for the 2nd generation of its Optune device for treating glioblastoma, a form of brain cancer. The FDA approved Optune’s 1st iteration in April 2011. It’s a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields,” […]
Torax wins FDA HDE clearance for Fenix incontinence system
Torax Medical said today its Fenix continence restoration system won FDA Humanitarian Device Exemption approval for treating fecal incontinence. The Fenix system is made up of a series of magnetic titanium beads that are implanted in the anal sphincter to minimize the involuntary opening of the anal canal. The system comes with a tool to size the […]
Senate health committee to vote on FDA nominee Califf
The U.S. Senate’s health committee is slated to vote Jan. 12 on President Barack Obama’s nominee to be FDA commissioner, Dr. Robert Califf. Califf, a cardiologist and longtime Duke University researcher, joined the FDA as a deputy commissioner in January 2015. Although he’s won praise from Sen. Lamar Alexander (R.-Tenn.), chairman of the Senate Health, Education, Labor & Pensions […]
FDA slaps PMA requirement on pelvic mesh
The FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review. The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through […]