SpineVision recently announced that it has received FDA clearance and CE Mark approval for its titanium 3D laser-printed Hexanium TLIF cage for back surgery. Spine fusion surgery is used to stop the motion of a painful segment in the spine by fusing two of the vertebrae with a TLIF cage. The procedure is used to
Heidelberg Engineering wins FDA nod for upgraded eye imaging technology
September 20, 2018 By Leave a Comment
The FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular diseases. OCTA is a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Structural
Southern Implants wins FDA nod for Provata dental implant
September 19, 2018 By Leave a Comment
Southern Implants North America recently received FDA 510(k) clearance for its internal hex dental implant system, the Provata. The Provata is commercially available in the U.S. It complements the company’s External Hex Implant with an internal hex connection. It is available in three forms, including standard, a unique Co-Axis with Subcrestal Angle Correction and ProMax
Meditech Spine wins FDA nod for spinal implant system
September 18, 2018 By Leave a Comment
Meditech Spine said today it has received FDA 510(k) clearance to market the CURE Opel-C Plate spinal implant system, an add-on technology to its already cleared CURE anterior cervical plate (ACP) system and Talos-C hydroxyapatite (HA) interbody systems. With this approval, Meditech will now offer two additional CURE ACP plating options with its Talos
FDA clears AMDT’s SixFix deformity correction software
September 17, 2018 By Leave a Comment
AMDT Holdings recently announced that its SixFix deformity analysis and correction software and instrumentation. The SixFix system is indicated for use with Smith & Nephew’s Taylor Spatial Frame to reduce the time and effort that comes with manually inputing measurement and values that are required by currently available alternative. It also creates a prescription that
CoreLink Surgical wins FDA clearance for stand-alone anterior lumbar system
September 17, 2018 By Leave a Comment
CoreLink Surgical announced that it has received FDA 510(k) clearance for its M3 Stand-Alone Anterior Lumbar (ALIF) System. “M3 is our first stand-alone inter body fusion device to feature 3D printing. I continue to be impressed by the ability of our design teams to rapidly turn direct feedback and market demand into commercially competitive products,”
FDA clears Olympus’ latest biopsy needle
September 14, 2018 By Leave a Comment
Olympus said it has won FDA clearance for its EZ Shot Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine needle aspiration (FNA) and fine needle biopsy (FNB). The approvals “can drive improved staging of disease and the potential to more easily connect patients
IlluminOss Medical receives FDA clearance for bone stabilization system
September 13, 2018 By Leave a Comment
IlluminOss Medical recently announced that it received FDA clearance for its Photodynamic Bone Stabilization System. The clearance allows the system to be used in skeletally mature patients for treating traumatic, facility, pathological and pathological fractures of the humerus, radius and ulna. “IlluminOss’s minimally invasive approach is ideal for treating patients suffering from fragility fractures. With
FDA works with technology industry to promote digital health innovation
September 13, 2018 By Leave a Comment
Scott Gottlieb, FDA commissioner; Jeff Shuren, Center for Devices and Radiological Health director Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better-informed decisions about their medical care and healthy living. These advances enable better health outcomes
Webinar: Here’s how 2018 is wrapping up for medtech
September 12, 2018 By Leave a Comment
Tuesday, Oct. 9, 2018 11:30 a.m. Eastern time / 8:30 a.m. Pacific time It’s been a busy third quarter for the medical device industry. In this webinar, MassDevice and Medical Design & Outsourcing editors Fink Densford and Sarah Faulkner will explore the latest technology approvals, clinical trials and acquisitions that have emerged in
FDA clears PhysIQ’s AFib detection analytics system
September 12, 2018 By Leave a Comment
PhysIQ recently received FDA 510(K) clearance for its atrial fibrillation detection analytics system. The clearance expands the company’s cleared analytics that are designed to create clinical insight from wearable biosensors, commercializing AI-based physiology analytics. The recently cleared analytic system is available through the company’s pinpointIQ for patient care delivery and accelerateIQ platform for clinical trials.
FDA to step-up cybersecurity scrutiny in med device clearances
September 11, 2018 By Leave a Comment
The FDA is taking steps to increase its scrutiny of efforts taken by medical device developers to limit cybersecurity vulnerabilities in their connected products, but may need to take extra steps, according to a newly released report from the US Dept. of Health and Human Services’ Office of Inspector General. The report analyzed the FDA’s
FDA issues draft guidance on covering uncertainty in benefit-risk determinations
September 6, 2018 By Leave a Comment
The FDA this week released draft guidance covering uncertainty in making benefit-risk determinations for certain medical devices, laying out the factors that the agency considers for such determinations. At the top of the agency’s list are considering “the extent of the probably benefits of the device, including type, magnitude, probability, duration and frequency of those
New program with payors aims to accelerate patient access to medical devices
September 6, 2018 By Leave a Comment
Scott Gottlieb, M.D. Advancing the public health means helping to make sure patients have access to safe, effective medical products. Access is a matter of public health. And our commitments to patients don’t stop at the time of a product’s approval. We take many steps to make sure products can be safely accessed in the
FDA: Labeling requirements to add 2m hours to medtech industry’s regulatory burden
September 5, 2018 By Leave a Comment
New FDA labeling regulations submitted to the FDA’s Office of Management and Budget are expected to add an additional approximate 1.6 million hours of work to record keepers at the agency and in the industry, according to an FDA notice The added burden comes from changes to the federal watchdog’s medical device labeling regulations, which
