The FDA today said it cleared the first fully disposable duodenoscope, made by Boston Scientific. The EXALT Model D Single-Use Duodenoscope is designed for use in endoscopic retrograde cholangiopancreatography procedures. It is the first single-use duodenoscope on the market and was granted Breakthrough Device Designation. “The availability of a fully disposable duodenoscope represents another major […]
FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller
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 […]
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 […]
Iradimed renews CE mark for MRI-safe patient monitor
Iradimed (NSDQ:IRMD) today said it completed the CE mark renewal process and resumed shipments of its patient vital signs monitoring systems. “We are very pleased with obtaining the CE mark renewal certificate for our patient monitors. With the renewed certificate, we are immediately resuming shipments to the impacted customers and thank them for their patience,” president […]
Flexicare recalls fiber optic laryngoscope blades and handles
Flexicare Medical today issued a recall for its BritePro Solo and BriteBlade Pro single-use fiber optic laryngoscope blades and handles due to a risk of choking. According to a medical device alert pertaining to England, Scotland, Wales and Northern Ireland, the BritePro Solo and BriteBlade Pro contain loose bearings and a retaining ring that may […]
Beta Bionics’ bionic pancreas wins breakthrough status from FDA
The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The approval covers all configurations of the device — insulin-only, glucagon-only, and bihormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution. The iLet Bionic Pancreas System is a pocket-sized, wearable investigational medical device that […]
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 […]
ViewRay issues urgent field safety notice for MRIdian System Treatment Planning and Delivery System
ViewRay (NSDQ:VRAY) has issued a field safety notice for its MRIdian System Treatment Planning and Delivery System software. The urgent device correction stems from some cases where a dose that was previously administered to a patient may not be accurately registered with the daily scan. There have been no reports of patients affected by the issue. […]
FDA clears augmented glenoids for Shoulder Innovations system
Shoulder Innovations announced today that it won FDA clearance for its InSet Plus augmented glenoids for the InSet total shoulder system. The Holland, Mich.-based company’s InSet system is designed to treat significant disability in degenerative, rheumatoid and traumatic disease of the glenohumeral joint and avascular necrosis of the humeral head. Shoulder Innovations said its product […]
Roche wins CE Mark for blood glucose reading smartphone app
Roche (SWX: RO, ROG) today announced that it has obtained a CE Mark for its Accu-Chek SugarView app, which allows a person to read a blood glucose test strip without a meter. The smartphone app, which will be first available on certain phone models via the Google Play Store, instead uses the phone’s camera to […]
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