Early stage, spinal-focused medical device maker Viseon said today it won FDA 510(k) clearance for its minimally-invasive Voyant system intended for accessing, visualizing and illuminating spinal procedures. The Voyant system is composed of a sterile single-use, disposable retractor device featuring integrated visualization technology and a reusable controller for manipulation of the surgical site image. The […]
FDA clears Transseptal Solutions’ TP Crosser transseptal access device
Medtech developer Transseptal Solutions said yesterday it won FDA 510(k) clearance for its TSP Crosser transseptal access system. The Israel-based company said that the TSP Crosser is an advanced transseptal puncture system which features a built-in steering mechanism and is designed for use in accessing the left atrium. The system is intended for use during […]
FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence
TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
Acessa Health wins FDA nod for 3rd-gen ProVu
Acessa Health said today it won FDA 510(k) clearance for its third-gen Acessa ProVu radiofrequency ablation system intended for use in treating symptomatic uterine fibroids. The Austin, Texas-based company said the newly cleared system features ultrasound visualization and a guidance mapping system, and that it is intended to provide a safe alternative to hysterectomy procedures for […]
FDA clears Xtreem Pulse’s PureFlow counter pulsation system
Preventive healthcare tech company Xtreem Pulse said today it won FDA 510(k) clearance for its PureFlow system designed to treat refractory chronic stable angina. The New York-based company said that the system was designed on a concept called external counter-pulsation, and was originally designed to improve unhealthy cardiovascular function. The company also claims the system […]
FDA launches pilot to shorten some 510(k) approval times
The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets. The Quality in 510(k) “Quik” Review Program uses the agency’s eSubmitter software to format each submission and accepts 39 product codes for device types that it considers to be well-understood by the […]
B-One Ortho wins FDA nod for total hip system
Early stage orthopedic tech company B-One Ortho said today it won FDA 510(k) clearance for the B-One total hip system, touting it as its first device clearance from the agency. The B-One is a cementless total hip system which features coating technology and instrumentation intended to optimize patient fit for a modern patient demographic, the […]
Motus GI wins FDA nod for Pure-Vu slim colonoscopy sleeve
Motus GI said today that it won FDA 510(k) clearance for its Pure-Vu slim sleeve as part of its Pure-Vu system, intended for use during slim colonoscopies. With the clearance of the Pure-Vu slim sleeve, Motus GI said that the Pure-Vu system is now cleared for the full range of procedures in the colonoscopy market, with […]
Iridex wins FDA 510(k) for TruFocus LIO premiere ophthalmological laser
Iridex (NSDQ:IRIX) said yesterday it won FDA 510(k) clearance for its TruFocus LIO premiere ophthalmological laser accessory and that it launched the device in the US. The TruFocus LIO Premiere is a light combination and reflection viewing system designed to be used with the Iridex retina laser system, the Mountain View, Calif.-based company said. The newly […]
FDA clears Surgical Innovation’s DuraSorb bioresorbable mesh
Medical device start-up Surgical Innovation Assets said yesterday it won FDA 510(k) clearance for its DuraSorb monofilament mesh, designed for reconstructive and cosmetic surgery. The newly cleared DuraSorb mesh is the first from a line of advanced bioresorbable technologies, the Chicago-based company said. The DuraSorb is intended to integrate into the patient’s tissue to provide […]
TransEnterix submits FDA clearance bid for Senhance ultrasonic instrumentation
TransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission for its Senhance Ultrasonic instrument system, designed to operate with its Senhance robotic platform. The Research Triangle Park, N.C.-based company said that the approval would allow the system to utilize ultrasonic devices designed to deliver controlled energy to ligate and divide tissue and minimize thermal injury […]
- 1
- 2
- 3
- …
- 58
- Next Page »
MassDevice Network
@MassDevice
LinkedIn