Aidoc said today it has received FDA 510(k) clearance for AI-powered X-ray detection of pneumothorax, also known as a collapsed lung. It’s the latest indication for New York-based Aidoc’s triage and notification system, which has already been FDA 510(k) cleared for flagging suspected intracranial hemorrhage, large vessel occlusions, acute cervical spine fractures, pulmonary embolism, incidental […]
FDA
CartiHeal wins FDA premarket approval for its Agili-C knee implant
CartiHeal announced today that it received FDA premarket approval for its Agili-C implant for treating knee joint surface lesions. Kfar Saba, Israel-based CartiHeal designed its Agili-C implant as a proprietary implant for treating cartilage lesions in arthritic and non-arthritic joints. Its PMA indication covers the treatment of an International Cartilage Repair Society (ICRS) grade III […]
FDA’s $8.4B budget request includes supply chain, pandemic prep and cancer funding
The FDA today said it wants a $2.1 billion funding bump as it released details of its $8.4 billion budget request for fiscal year 2023, which starts Oct. 1, 2022. The budget request includes full funding of the agency’s fiscal 2022 budget request, plus new programs and initiatives that would affect medical device developers and […]
FDA clears Ossio’s OssioFiber suture anchors for bone fixation
Ossio announced today that it received the third FDA clearance for its OssioFiber product family in recent months. Woburn, Massachusetts-based Ossio’s latest regulatory nod covers the OssioFiber suture anchors (4.75 mm-5.5 mm) for use in the fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in a variety of […]
Staar Surgical wins FDA approval for Evo Visian implantable Collamer lens
Staar Surgical (Nasdaq:STAA) announced today that it received FDA approval for its Evo/Evo+ Visian implantable Collamer lens. Lake Forest, California-based Staar Surgical designed the Evo biocompatible implantable lens for the correction of myopia and myopia with astigmatism. More than 1 million Evo lenses have been implanted by doctors outside the U.S., according to a news […]
FDA clears Biobeat’s remote vital sign monitoring system
Biobeat announced today that it received FDA 510(k) clearance for its wearable remote patient monitoring device. FDA clearance allows the wearable device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate. Petah Tikva, Israel-based Biobeat’s wireless wrist and chest monitoring devices became the first of […]
What you need to know about the FDA’s Total Product Life Cycle Advisory Program pilot
An FDA initiative meant to enhance medical device development is closer than ever to becoming a reality after it survived negotiations with the industry over the Medical Device User Fee Amendments (MDUFA) reauthorization. My last post on MDUFA V touched on the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot laid out in the regulatory […]
Cutera’s AviClear acne device wins FDA clearance
Cutera (Nasdaq:CUTR) announced today that it received FDA 510(k) clearance for its AviClear acne treatment device. Brisbane, California-based Cutera designed AviClear as a laser treatment for the safe, prescription-free reduction of existing acne. The company said breakout episodes are shorter, less intense and more infrequent following use. Cutera said AviClear is the only energy-based device […]
Sterifre Medical prepares to launch its Aura desktop disinfection device
Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system. The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit […]
Lazurite wins FDA clearance for its wireless camera system for minimally invasive surgery
Lazurite (formerly Indago) announced today that the FDA cleared its ArthroFree wireless camera system for minimally invasive surgery. Cleveland-based Lazurite designed the ArthroFree system to incorporate its proprietary low-heat, high-intensity Meridiem light engine technology with advanced camera, battery and wireless transmission technologies and drop-in compatibility with patient data consoles, surgical displays and endoscopes. The company […]
FDA releases MDUFA V details after industry negotiations
The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA). If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after […]