Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that limit central venous access through […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
11 states ask EPA to crack down on ethylene oxide emissions
Eleven state attorneys general are urging the U.S. Environmental Protection Agency to impose stricter regulations over commercial operations that emit ethylene oxide (EtO), a widely used medical device sterilant gas. The EPA, which considers EtO a carcinogen, has been fielding comments on it in light of public outcry over emissions from medtech sterilization plants during […]
FDA clears Varian’s AI-driven radiation therapy
Varian Medical Systems (NYSE:VAR) announced today that it won FDA 510(k) clearance for its Ethos AI-driven adaptive intelligence solution for cancer care. Ethos is designed to offer an adaptive treatment based on the patient’s anatomy and position to better target the tumor, reduce the dose to healthy tissue and improve overall outcomes within a 15-minute time […]
Baxter, Cosmed win FDA clearance for portable metabolism monitor
Baxter (NYSE:BAX) announced that it won FDA 510(k) clearance for the Q-NRG+ metabolic monitoring device developed by its partner Cosmed for helping with nutrition therapy. Q-NRG+ uses indirect calorimetry (IC) technology to measure a patient’s calorie needs or resting energy expenditure (REE). Together, those readings can be used to inform prescription and administration of nutrition therapy, […]
Medicrea wins FDA clearance for patient-matched spinal interbody cages
Medicrea (EPA:ALMED) announced today that it won FDA clearance for its UNiD IB3D patient-matched interbody cages to complete its UNiD adaptive spine intelligence (ASI) platform technology. The UNiD IB3D interbody cages are 3D-printed titanium implants designed to customize cage dimensions, features and endplate morphology. Medicrea touts this level of customization as the first of its kind […]
FDA clears Rist Neurovascular radial artery catheter
Rist Neurovascular announced today that it won FDA 510(k) clearance for its Rist Cath radial access long sheath for accessing the neurovasculature through the radial artery in the wrist. The Miami Beach, Fla.–based company touts the Rist Cath as the first device specifically designed to access the neurovasculature through the radial artery, which could open […]
BioIntelliSense wins FDA nod for BioSticker continuous vital sign monitor
BioIntelliSense announced that it won FDA 510(k) clearance for its BioSticker on-body sensor for scalable remote care and initiated the U.S. commercial launch of the product last week. The BioSticker is designed to allow for continuous monitoring of vital signs and actionable insights to provide opportunities for early detection of potentially avoidable complications from a […]
FDA clears Paragonix donor lung preservation system
Paragonix Technologies announced today that it won FDA 510(k) clearance for its LUNGguard donor lung preservation system. Paragonix designed the LUNGguard for the hypothermic preservation of lungs during transportation and the eventual transplantation into a recipient using cold storage solutions. LUNGguard is indicated for a storage time of up to eight hours. Cambridge, Mass.–based Paragonix’s […]
GreenBone Ortho wins CE Mark for bone graft made of transformed wood
GreenBone Ortho announced that it received CE Mark approval for its bone substitute product that could serve as an alternative to traditional bone grafts. The Faenza, Italy–based company’s bone substitute is designed to limit the surgical and postoperative complications related to bone defects that are either created surgically or have resulted from traumatic injuries to […]
FDA authorizes use of Caption Health’s AI software to capture heart images via ultrasound
The FDA announced today that it has authorized the marketing of Caption Health’s Caption Guidance software for assisting in the acquisition of cardiac ultrasound or echocardiography images. Caption Guidance is an accessory to compatible diagnostic ultrasound systems designed to use artificial intelligence to help capture images of a patient’s heart that are of acceptable diagnostic […]
Aria CV wins breakthrough nod for pulmonary arterial hypertension device
Aria CV announced that it won FDA breakthrough device designation for its pulmonary hypertension (PH) system for treating pulmonary arterial hypertension (PAH) that can lead to heart failure. The implanted system is designed to restore the benefits of a healthy, elastic pulmonary artery, according to a news release. The restoration should lead to reduced cardiac […]