The FDA today cleared the Tandem Diabetes Care (NSDQ:TNDM) t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The agency also granted De Novo clearance to the Control-IQ device, which is compatible with a variety of continuous glucose monitors and insulin pumps. The t:slim system, which also includes the recently approved Dexcom […]
Axonics raises additional $17m in public offering
Sacral neuromodulation device-maker Axonics Modulation Technologies (NSDQ:AXNX) announced that the underwriters of its follow-on public offering exercised in full their option to buy an additional 750,000 shares of common stock. The additional shares are set to be purchased from Axonics at the offering price of $22 per share, less underwriting discounts and commissions, according to a news […]
Sterigenics’ legal troubles mount in Illinois
Nearly two dozen new lawsuits were filed against Sterigenics this week over its now-shuttered ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., according to a law firm representing some of the plaintiffs. That brings the total of such lawsuits to nearly 75, noted Chicago personal injury lawyer Antonio Romanucci, court-appointed lead counsel from among five firms involved in the […]
Senate confirms Dr. Stephen Hahn to lead FDA
The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer […]
FDA clears Cochlear piezoelectric hearing implant
The FDA has cleared a second-generation pioezoelectric bone-conduction hearing implant from Cochlear (ASX:COH), the company announced today. The Osia 2 system is an active osseointegrated, steady-state implant (OSI) that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear. It is designed to […]
Drug or device? FDA loses this argument for now
This article has been updated with comments from an attorney for Genus Medical Technologies. A federal judge has temporarily blocked an attempt by the FDA to regulate a barium sulfate product ingested before imaging as a drug. The decision counts as at least a partial win for Genus Medical Technologies (St. Louis), maker of the […]
House bill asks CMS to cover breakthrough devices for Medicare patients
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 […]
EPA moves closer to stricter regulation of 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 […]
Viant to cease ethylene oxide sterilization at Michigan plant by year’s end
Viant Medical has signed a consent order to stop sterilizing medical devices using ethylene oxide (EtO) at its plant in Grand Rapids, Mich. by Dec. 31, 2020, according to the Michigan Department of Environment, Great Lakes, and Energy (EGLE). Viant also agreed to stop using ethylene oxide (EtO) at the plant by Jan. 31, to conduct monthly air […]
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 […]
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