This article has been updated with comments from the FDA and from Madris Tomes. A new investigation of FDA adverse event data has revealed that more women are harmed by medical devices than men. The report published by the International Consortium of Investigative Journalists (ICIJ) shows that among 340,000 people whom the FDA listed as […]
Hologic wins CE mark approval for implantable tag
Hologic (NSDQ:HOLX) announced that it won an extension of the CE Mark approval for its LOCalizer radiofrequency identification (RFID) tag for long-term placement. Under yesterday’s extension approval, the LOCalizer can now be implanted more than 30 days prior to a breast-conserving surgery to improve flexibility and convenience for both patients and providers. The LOCalizer is a […]
EOS Imaging launches next-gen imaging system
EOS Imaging (EPA:EOSI) announced the launch of its new EOSedge next-generation imaging system in Europe, Canada and Australia. EOSedge is a combination of X-ray detection, low-dose radiation and high-resolution imaging in the delivery of musculoskeletal imaging exams. It includes EOS Imaging’s Flex Dose technology for modulating radiation dose along the patient’s body, along with high-resolution photon […]
Coloplast recalls stents due to package sterility issue
Coloplast (CPH:COLO-B) recalled nine total batches of its Biosoft Duo double loop ureteral stent kit and Vortek double loop ureteral stent kit due to a packaging anomaly. Humlebaek, Denmark–based Coloplast issued an urgent field safety notice out of Germany earlier this month to warn users of the packaging issue and instruct them to review stock and […]
MedTech Europe slams EU over lack of preparation for MDR/IVDR
With six months to go before the EU’s new Medical Device Regulation takes effect, Europe’s medtech trade association is accusing government authorities of dragging their feet on the process. MedTech Europe said that the industry is trying to prepare but that it remains “seriously held back by the slow and piecemeal implementation” of the new […]
Stimwave Technologies stops commercialization of products in Australia
Stimwave Technologies announced today that it is stopping the commercialization of its product lines in Australia until its entire product family can be legally marketed in the country. The neuromodulation therapy alternative developer’s products include the Freedom SCS system and the StimQ PNS system, which are designed to reduce the risks associated with implantable pulse […]
Venus Concept wins CE Mark and Health Canada approval
Venus Concept (NSDQ:VERO) announced today that it won CE Mark and Health Canada approval for its Venus Epileve device for hair removal, reduction and more. The Epileve is intended to treat hirsutism (male-pattern hair growth in women), permanent hair reduction and pseudofolliculitis barbae (condition in which shaving causes inflammation and bumps to develop on the […]
Tusker Medical’s pediatric ear tubes land breakthrough device designation
The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the […]
Renovia lands FDA clearance for updated pelvic device
Renovia announced today that it won FDA 510(k) clearance for its next-generation Leva pelvic digital therapeutic for urinary incontinence (UI) in women. The Leva system is designed to strengthen pelvic floor muscles and treat stress incontinence as well as mixed and mild-to-moderate urgency UI in women. It uses Renovia’s patented movement-based sensor and app technology […]
FDA moves to reduce ethylene oxide use
This article has been updated with a comment from the trade group AdvaMed. The FDA today announced steps it wants the medtech industry to take to reduce its reliance on ethylene oxide (EtO) as a sterilant. Based on testimony it received at a recent advisory panel meeting on the sterilant gas, which the EPA considers carcinogenic, the […]
FDA scheduled to ban behavior-control devices
The FDA is close to enacting a ban on electrical stimulation devices sometimes used to treat self-harm and aggression used in people with intellectual or developmental disabilities. The agency, which rarely bans medical devices, proposed the ban on the devices in 2016 because they present “an unreasonable and substantial risk of illness or injury to the public.” Some […]
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