LifeSignals today announced that it has received FDA 510(k) clearance for its LX1550 multi-parameter remote monitoring platform. Fremont, Calif.–based LifeSignals designed the LX1550 to continuously collect patient physiological data from home and in healthcare settings. Get the full story on our sister site, Medical Design & Outsourcing.
Regulatory/Compliance
How COVID-19 changed medical device clinical trials forever
The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials. DeviceTalks Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on […]
Philips CPAP recall is Class I
FDA today designated a Philips recall of certain sleep and respiratory devices as Class I, its most serious level. Devices in the recall number in the millions, according to FDA’s database. There have been more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. The foam has […]
Innovative Health Sciences wins CE mark for syringe infusion system
Innovative Health Sciences announced today that it received CE mark approval in Europe for its Insignis syringe infusion system. Chester, N.Y.-based Innovative Health Sciences designed the Insignis syringe infusion system to offer a combination of intravenous and subcutaneous non-electric infusion for use with a selectable rate flow controller — the IV Controller and the OneSett. Get […]
FDA seeks expanded authority to boost medical device supply chain
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 […]
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 […]
NeuroMetrix stock skyrockets on news of FDA breakthrough device designation
NeuroMetrix (NSDQ:NURO) today announced that its Quell device has received FDA breakthrough designation for treating fibromyalgia symptoms in adults. The news saw NURO shares nearly triple in value to $9.72 apiece near the close of trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up 1.5%. Fibromyalgia involves the […]
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 […]
