The FDA announced as part of its annual budget proposal that it will seek $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP). Funding from the RSCSPP for the Center for Devices and Radiological Health (CDRH) will provide — the FDA says, for the first time — resources to establish a […]
FDA
Philips wins breakthrough nod for laser-assisted IVC filter removal device
Royal Philips (NYSE:PHG) announced today that it received FDA breakthrough device designation for its laser-assisted IVC filter removal device. Amsterdam-based Philips designed its laser-assisted inferior vena cava (IVC) filter removal device to ablate tissue to remove an IVC filter when previous methods of removal have failed, according to a news release. IVC filters are used […]
FDA approves Nevro’s Senza system to treat chronic pain with diabetic neuropathy
Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. The Redwood City, Calif.-based company’s stock was up nearly 6%, to 152.54 per share, by afternoon trading today. Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation. The company is touting that it […]
Endologix wins FDA breakthrough nod for aneurysm sealing system
Endologix announced today that the FDA granted breakthrough device designation for its Chimney endovascular aneurysm sealing system (Chevas). Irvine, Calif.–based Endologix designed its Chevas system as an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy that combines the Nellix 3.5 endograft with parallel visceral stents to treat patients with juxtarenal, pararenal and suprarenal AAA, according […]
FDA clears Dexcom Partner Web APIs
Dexcom (NSDQ:DXCM) announced today that it received FDA clearance for its Dexcom Partner Web application programming interfaces (APIs). The San Diego–based company’s Dexcom Partner Web APIs enable invited third-party developers to integrate real-time continuous glucose monitoring (CGM) data into their digital health apps and devices. Get the full story at our sister site, Drug Delivery Business […]
FDA raises concerns about NuVasive Magec devices
The FDA today issued a notice warning patients, caregivers and healthcare providers of potential issues with Magec devices from NuVasive (NSDQ:NUVA). NuVasive’s Magec, a growing spinal rod system intended for use in children under 10, uses magnets to help correct spinal deformities as the child grows. The company designed Magec to help avoid multiple operations while […]
FDA grants iStar Medical IDE for glaucoma implant pivotal trial
iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, which will enroll over 350 patients with primary open-angle glaucoma. Get the full story at our sister site, Drug […]
FDA advisory panel gives positive ruling on TransMedics OCS Liver System
TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote supporting approval for its OCS Liver System. Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review […]
Nasdaq halts trading of TransMedics stock with FDA set to review OCS Liver System
TransMedics (NSDQ:TMDX) announced today that the Nasdaq market halted trading of the company’s common stock. Andover, Mass.-based TransMedics, which develops organ transplant transportation platforms, saw its common stock close down -5.3% at $31.69 yesterday. The company awaits the outcome of today’s meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory […]
Avanos Medical to pay more than $22M to resolve criminal charges with DOJ
The U.S. Justice Dept. announced that Avanos Medical (NYSE:AVNS) agreed to pay more than $22 million to resolve a criminal charge related to fraudulent misbranding. Charges levied against the Alpharetta, Ga.-based medical device company relate to alleged fraudulent misbranding of its MicroCool surgical gowns. According to a DOJ news release, criminal information filed on July […]
FDA warns of biocompatibility concerns with NuVasive’s Precise devices
The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA). Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a […]
