Bayer (ETR:BAYN) failed to tell FDA about thousands of injury complaints related to its Essure contraceptive device, according to newly unsealed lawsuit documents reported by Bloomberg. The lawsuit documents out of California claim that the underreporting went back before Bayer acquired Essure maker Conceptus for $1.1 billion in 2013. Bayer responded to Bloomberg last week that […]
US FDA extends UDI deadlines for low-risk medical devices
By Stewart Eisenhart, Emergo Group Final guidance from the US Food and Drug Administration pushes back enforcement deadlines for certain Unique Device Identification (UDI) requirements for Class I and unclassified medical devices due partially to the agency’s coronavirus pandemic-related priorities. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
FDA plans to resume onsite inspections later this month
FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted them — though there will be changes due to the COVID-19 pandemic. The agency today said that it will pre-announce inspections to FDA-regulated businesses. Said FDA: “This will help assure the safety of the […]
FDA clears Infervision’s lung CT.AI system
Infervision announced that it received FDA 501(k) clearance for its InferRead Lung CT.AI system which uses AI to automatically perform lung segmentation. InferRead Lung CT.AI is designed to use AI and deep learning technology to support concurrent reading and aid radiologists in pulmonary nodule detection during the review of chest CT scans, increasing accuracy and […]
FDA clears new Baxter bone graft substitute
Baxter (NYSE:BAX) announced today that it received FDA clearance for its Altapore Shape bioactive bone graft for bone growth and fusion. Deerfield, Ill.-based Baxter’s Altapore Shape is its latest addition to its bone graft substitute product line, designed to enhance bone growth and aid in achieving fusion, leading to reduced pain and other improved clinical outcomes […]
iVWatch lands FDA clearance for continuous intravenous monitoring device
Continuous IV monitoring system developer ivWatch announced that it received FDA clearance for its new SmartTouch disposable sensor. SmartTouch is indicated for the early detection of peripheral IV infiltration and extravasation events. The latest FDA clearance expands ivWatch’s sensor portfolio to include the single-use sensor for all patient age groups. It is miniaturized and disposable and […]
Essure study shows more pain, bleeding in women with implant
Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control. The FDA posted the results as part of a long-term safety evaluation of the device, which has […]
FDA clears Nonin Medical flagship product
Nonin Medical (Plymouth, Minn.) announced today that it has received 510(k) clearance for its flagship product — the CO-Pilot wireless handheld multi-parameter system. The handheld, wireless CO-Pilot is meant to make it easier for EMS, firefighters and military personnel to measure a person’s key vital signs following a cardiac arrest, traumatic injury, carbon monoxide or […]
Soterix wins IDE for depression treatment trial
Soterix Medical announced today that it received FDA investigational device exemption (IDE) to launch a trial of its tDCS-LTE) neuromodulation system. New York-based Soterix Medical’s transcranial direct current stimulation-limited total energy (tDCS-LTE) system is an at-home platform for people suffering from major depressive disorder (MDD). The proprietary technology is designed to support the home-based tDCS, […]
Medtronic Linq II insertable cardiac monitor gets OK in U.S., Europe
Medtronic (NYSE:MDT) announced today that its Linq II insertable cardiac monitor has received FDA clearance in the U.S., as well as a CE Mark in the EU. The Linq II boasts remote programming. That means a person with the Linq II implanted inside of them doesn’t need to return to the doctor’s office or hospital to […]
Dascena wins FDA beakthrough device designation for AI to predict kidney injury
Dascena announced today that it received FDA breakthrough device designation for its Previse algorithm for predicting acute kidney injury (AKI). The artificial intelligence (AI)-based algorithm is designed to predict AKI more than a full day before patients meet the clinical criteria for diagnosis. The company touts its regulatory victory as the first breakthrough nod for […]
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