U.S. Rep. Suzan DelBene (D-Wash) reintroduced a bill today to improve Medicare patient access to breakthrough medical devices. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) would require Medicare to temporarily cover all devices approved through the FDA’s breakthrough pathway for three years, during which the Centers for Medicare and […]
MolecuLight wins FDA clearance for handheld imaging device
MolecuLight announced that it won FDA 510(k) clearance for its i:X handheld fluorescence imaging device for detecting wounds containing bacteria. MolecuLight i:X is designed to enable real-time point-of-care visualization of fluorescence in wounds, while it measures wounds and digitally records images and measurements. It received FDA de novo clearance in August 2018. The device’s fluorescence […]
EPA moves closer to stricter regulations on medtech ethylene oxide sterilization
The Environmental Protection Agency yesterday asked the commercial ethylene oxide (EtO) industry, which includes medical device sterilizers, for input on next year’s updated regulation of emissions of the carcinogenic gas. Specifically, the EPA is requesting comment on available control technologies for reducing EtO emissions and on developments in practices, measurement, monitoring, processes and control technologies for the […]
3DBio Therapeutics wins FDA rare pediatric disease designation for outer ear reconstruction
3DBio Therapeutics announced today that the FDA granted it rare pediatric disease designation for the AuriNovo outer ear reconstruction system for patients with microtia. According to the New York–based company, there are currently no other established treatments for microtia that allow a patient to regain an auricle comprising living tissue aside from limited rib grafts […]
Vicarious Surgical wins FDA breakthrough designation for surgical robot
Vicarious Surgical announced that it won FDA breakthrough device designation for its virtual reality-based robot-assisted surgical device. Charlestown, Mass.–based Vicarious has said its device for minimally invasive procedures “combines virtual reality with proprietary human-like surgical robotics to enable surgeons to perform minimally invasive surgery through a single micro-incision.” The company claims to have achieved “the […]
J&J Vision launches Tecnis Toric II intraocular lens in U.S.
Johnson & Johnson (NYSE:JNJ) Vision announced that, after winning FDA approval, it launched the Tecnis Toric II one-piece intraocular lens (IOL) to treat astigmatism in cataract patients. The Tecnis Toric II IOL is Johnson & Johnson Vision’s first approved product within the Tecnis Toric II platform, which offers more surface texture and friction on IOL haptics, […]
FDA clearance positions Sight Diagnostics to deliver on two-drop blood testing promise
Today’s news that Sight Diagnostics secured 510(k) clearance for its Olo analyzer certainly will reduce the flow of future patient tears and fears as the system requires just two drops of blood to conduct a range of tests. However, the clearance — which confirms the Olo works just as well as gold-standard lab-grade systems in […]
Senate committee favors Hahn for FDA chief
A Senate panel has recommended approval of Dr. Stephen Hahn as the new commissioner of the FDA. The U.S. Senate Committee on Health, Education, Labor & Pensions voted 18 to 5 to approve the nomination of Hahn, the chief medical officer at Houston’s M.D. Anderson Cancer Center. Hahn would replace acting commissioner Dr. Brett Giroir, […]
FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA. That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 patients among […]
FDA clears SynchroSeal and E-100 generator for Intuitive’s da Vinci X, Xi platforms
Intuitive Surgical (NSDQ:ISRG) announced that it won FDA clearance for two technologies meant to improve da Vinci robot-assisted surgical procedures that require sealing. The FDA cleared Intuitive Surgical’s E-100 generator and its new SynchroSeal instrument for the da Vinci X and Xi robot-assisted surgical systems, the company said in a Nov. 26 news release. Intuitive’s E-100 […]
Report: More women harmed by medical devices than men
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 […]
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