Baxter issued an urgent medical device correction notice regarding its Novum IQ syringe infusion pump. This marks the second warning over the Novum IQ pumps in recent months. A few weeks ago, the deemed a Novum IQ recall Class I because the pump may incorrectly indicate the completion of an infusion. Deerfield, Illinois-based Baxter notified […]
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Eitan Medical’s Sapphire infusion pump recall is Class I
The FDA determined that the recall of certain Eitan Medical Sapphire infusion pumps is Class I, the most serious kind. Netanya, Israel-based Eitan recalled certain Sapphire pumps running software version Rev 16.10. The recall includes the Sapphire multi-therapy pump, the Sapphire Epidural pump and the Sapphire Plus pump. Eitan initiated the recall on Sept. 11, […]
Are investors overreacting on AtriCure after Medtronic’s Penditure launch?
BTIG analysts say a small survey of surgeons may indicate an oversell of AtriCure stock following Medtronic’s launch of a competing device. Medtronic this week launched the Penditure left atrial appendage (LAA) exclusion device, adding another system to a competitive space. AtriCure, Abbott and Boston Scientific all offer LAA devices, while Johnson & Johnson MedTech […]
FDA warning doesn’t affect Embecta syringes, company says
Embecta (Nasdaq:EMBC) says an FDA safety communication regarding certain plastic syringes has no impact on its own products. The FDA yesterday warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese […]
Nevro acquires joint fusion device maker Vyrsa, closes credit facility and refinancing
Nevro (NYSE:NVRO) announced that it acquired Vyrsa Technologies, a company developing a minimally invasive joint pain treatment. Vyrsa has a portfolio of sacroiliac (SI) joint pain devices for use in SI joint fusion procedures. Established in 2021, the company manufactures and supports a complete portfolio of FDA-cleared devices. Dr. David Caraway, Nevro chief medical officer, […]
Qnovia has positive results for inhaled smoking cessation therapy
Qnovia announced positive results from its first-in-human study for the QN-01 inhaled smoking cessation therapy. Richmond, Virginia-based Qnovia develops the RespiRx drug delivery platform that leverages a vibrating mesh nebulizer. CEO Brian Quigley explained the technology to Drug Delivery Business News last year. The company designed the QN-01 therapy to meet the need for safe and effective […]
Procyrion enrolls first patient in IDE trial for mechanical circulatory support tech
Procyrion announced today that it enrolled the first patient in its investigational device exemption trial of the Aortix system. The DRAIN-HF study evaluates the Aortix percutaneous mechanical circulatory support (pMCS) technology. Patients in the trial present acute decompensated heart failure (ADHF) and remain unresponsive to standard medical therapy. Dr. Bassem Chehab enrolled the first patient […]
BD launches SiteRite vascular access ultrasound system
BD announced today that it launched its new SiteRite 9 advanced ultrasound system for helping with vascular access device placement. Franklin Lakes, New Jersey-based BD designed the system to help improve clinician efficiency when placing these devices. They include peripherally inserted central catheters (PICCs), central venous catheters, IV lines and other vascular access devices. SiteRite […]
Elon Musk denies Neuralink monkey death claims, U.S. lawmakers want SEC probe
Elon Musk has responded to claims of grisly deaths suffered by test monkeys as a result of his Neuralink venture’s brain implant. Musk’s Neuralink brain-computer interface (BCI) company has been in the news for positive reasons over the past year or so. The company won regulatory for a first-in-human implant in May, and in September it opened […]
Johnson & Johnson MedTech enters LAA device space with acquisition of Laminar
Johnson & Johnson MedTech announced today that it completed the acquisition of left atrial appendage (LAA) device maker Laminar. The deal, which includes a $400 million upfront payment, adds Johnson & Johnson MedTech to the crowded LAA device space. Established devices like Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman already exist within the market. Medtronic […]
Bright Uro raises $23M Series A to support urodynamics system
Bright Uro announced today that it closed $23 million in a Series A funding round to support its Glean urodynamics system. Irvine, California–based Bright Uro plans to use the funding to help garner FDA 510(k) clearance for Glean. It set its sights on a U.S. launch for the product in 2024. Glean, a comprehensive system, […]
