FDA Archives - Page 11 of 103 - Medical Design Sourcing

Boston Scientific wins expanded FDA clearance for Visual Ice cryoablation system

The Visual Ice cryoablation system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced today that it received expanded FDA 510(k) clearance for its Visual Ice cryoablation system.

News of the regulatory nod comes just weeks after the FDA approved the company’s POLARx cryoablation system for treating paroxysmal AFib.

Clearance grants the device an indication expansion for use in the treatment of pain associated with tumors. These tumors metastasized to bone in patients who can’t receive standard radiation therapy or for whom radiation provides no relief.

This makes Boston Scientific the first company in the U.S. to receive an on-label indication for cryoablation of bone metastases. According to a company spokesperson, this enables cryoablation to offer rapid and durable pain relief for these patients. Such patients take opioids and non-opioid analgesics or undergo radiation th…

After Medtronic’s latest setback, what’s next for Symplicity Spyral RDN?

Medtronic’s Symplicity Spyral device is a multi-electrode radiofrequency catheter for renal denervation. [Image courtesy of Medtronic]

Medtronic’s Symplicity Spyral renal denervation (RDN) system for treating hypertension seems less likely now than ever to win FDA approval after yesterday’s vote Circulatory Systems Devices Panel vote.

The panel’s medical and statistical experts voted against recommending approval of Medtronic’s RDN therapy for hypertension under the proposed indications. While they supported approval of ReCor Medical’s competing RDN system one day earlier, a key difference was the failure of Medtronic’s RDN system to outperform hypertension drugs.

Medtronic acquired the technology through its takeover of Ardian in January 2011. Early clinical results were promising, but Medtronic announced in 2014 that its Symplicity HTN-3 trial failed to meet it…

FDA review panel questions Medtronic on Symplicity Spyral renal denervation system

Medtronic’s Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic faced tough questions about its Symplicity Spyral renal denervation (RDN) therapy for hypertension at today’s FDA review panel.

Medtronic is seeking approval of its Symplicity Spyral multi-electrode RDN catheter and Symplicity G3 radiofrequency generator “for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of anti-hypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.”

The stakes are high for Medtronic, which has been developing the technology for years in the belief that it could be a billion-dollar business and provide relief to millions of patients worldwide, reducing heart attacks, strokes and other serious events tied to high blood pressure.

The same FDA review…

FDA review panel questions Medtronic on Symplicity Spyral renal denervation system

Medtronic’s Symplicity Spyral renal denervation catheter delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic faced tough questions about its Symplicity Spyral renal denervation (RDN) therapy for hypertension at today’s FDA review panel.

Medtronic is seeking approval of its Symplicity Spyral multi-electrode RDN catheter and Symplicity G3 radiofrequency generator “for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of anti-hypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.”

The stakes are high for Medtronic, which has been developing the technology for years in the belief that it could be a billion-dollar business and provide relief to millions of patients worldwide, reducing heart attacks, strokes and other seriou…

Welldoc gets FDA nod for CGM-guided insulin bolus dosing software

The BlueStar platform. [Image from Welldoc]Welldoc announced today that it won the 11th FDA 510(k) clearance for its BlueStar digital diabetes management platform.

The clearance comes just a week after BlueStar received its 10th FDA clearance for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Welldoc’s newest clearance enables BlueStar to provide bolus insulin dose recommendations based on continuous glucose readings.

BlueStar can now offer dose recommendations based on the most recent glucose reading and rate of change from a compatible CGM. This feature enhances BlueStar’s existing digital coaching capabilities for guiding dietary and lifestyle decisions in diabetes management.

Get the full story at our sister site, Drug Delivery Business News.

FDA clears Wenzel Spine’s primaLOK for expanded indications

The primaLOK SP system. [Image from Wenzel Spine]Wenzel Spine announced today that it received FDA clearance for its primaLOK SP system for spinal fusion procedures.

Austin, Texas-based Wenzel Spine designed primaLOK SP to provide surgeons with an effective and reliable solution for spinal stabilization. It’s now commercially available in the U.S.

The system combines cutting-edge engineering with a patient-focused design, Wenzel Spine says. Its design aims to provide a comprehensive solution for spinal fusion procedures, according to the company. New clinical indications with FDA clearance allow for the use of primaLOK SP at multiple levels in treating lumbar spinal stenosis.

“We are proud to receive FDA clearance to update the clinical indications for primaLOK SP,” Wenzel Spine CEO William E. Wilson said. “This achievement reflects our ongoing commitment to innovation and excellence in our spinal solutions. We believe this system will sig…

MagAssist wins FDA breakthrough nod for ventricular assist device

The NyokAssist device. [Image courtesy of MagAssist]MagAssist announced today that it received breakthrough device designation from the FDA for its NyokAssist ventricular assist device.

The interventional VAD provides mechanical circulatory support for high-risk percutaneous interventions. It features a 9 Fr insertion size with a foldable catheter pump to facilitate insertion and removal. This reduces the vascular access and closure processes.

Its insertion size correlates with vascular complications, bleeding, blood transfusion and severe adverse cardiovascular events. MagAssist says that reducing interventional size mitigates the risk of vascular complications and better meets market demands. The company incorporated this as a key factor in the design of its NyokAssist technology.

Once positioned, MagAssist designed its catheter pump to operate in an unfolded form to ensure sufficient blood flow. It features an impeller within the pump to deliver greater …

Imidex wins FDA clearance for AI-powered X-ray software

Imidex announced that it received FDA 510(k) clearance for its flagship, AI-powered VisiRad XR software product.

VisiRad XR analyzes chest X-rays and highlights possible lung nodules and masses. It employs state-of-the-art machine learning techniques developed using curated training data from around the world.

According to Imidex, the software offers clinicians a closer look at often-overlooked lung lesions. This could enable the identification of future lung cancers in outpatient and emergency department settings.

“Radiologists are looking for solutions to help elevate their performance and reduce burnout,” said Dr. Raj Chopra, Imidex chief medical officer. “With volumes increasing and staffing decreasing, tools like VisiRad XR are beneficial not only for patient care, but for helping radiologists continue to practice to their full potential.”

More about the Imidex VisiRad XR solution

VisiRad XR offers a turnkey solution that plugs into the curre…

AngioDynamics wins FDA breakthrough nod for AngioVac system

AngioDynamics (Nasdaq:ANGO) announced that it received FDA breakthrough device designation for its AngioVac system.

The breakthrough nod includes proposed indications for the use of AngioVac in the non-surgical removal of vegetation from the right heart.

AngioVac, an on-circuit aspiration system, uses a venous drainage cannula to remove thrombi or emboli during extracorporeal bypass. It achieves this for up to six hours, allowing for removal while minimizing blood loss. The system recirculates blood through the AngioVac extracorporeal (venovenous) bypass circuit.

Target vessels include — but aren’t limited to — the iliofemoral vein, inferior vena cava, superior vena cava and right heart.

With breakthrough designation, AngioDynamics plans to engage with the FDA to achieve its new expanded indication for the right heart. The accelerated pathway expedites assessment and review processes for the system with more interactive and timely communicat…

FDA clears Welldoc BlueStar for personalized bolus insulin dosing recommendations

The BlueStar platform. [Image from Welldoc]Welldoc announced today that it received the 10th FDA 510(k) clearance for its BlueStar diabetes digital health solution.

The latest regulatory nod enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. Columbia, Maryland-based Welldoc aims to make this enhanced functionality available commercially in 2024.

Get the full story at our sister site, Drug Delivery Business News.

J&J used RWE for an expanded indication — and you can, too

Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions.

J&J MedTech’s Biosense Webster ThermoCool SmartTouch [Image courtesy of J&J MedTech]

Real-world evidence (RWE) took a big step forward recently when the FDA approved an expanded indication for a Johnson & Johnson MedTech ablation catheter.

For the first time, the federal medical device safety regulator approved a label expansion based on RWE from a retrospective study of health records documenting off-label use by physicians.

“The clinical evidence used to support the expansion of indications was based solely on an analysis of a dataset comprised of electronic health records from two hospital systems,” the agency said. “The FDA worked closely with the study sponsor to ensure that the RWE resulting from the analysis was both relevant and reliable…

FDA grants new approval for ZimVie Mobi-C implant, plans U.S. launch in the fall

The Mobi-C cervical disc [Image courtesy of ZimVie]ZimVie (Nasdaq: ZIMV) + announced today that the FDA approved a smaller height of its Mobi-C cervical disc.

The updated approval covers Mobi-C in seven footprints that address the anatomical needs of patients in the U.S. Mobi-C has been used for cervical disc replacement to treat patients in France since 2004. In 2013, it became the first cervical disc approved for one and two contiguous levels by the FDA.

“The approval of the 4.5mm Mobi-C is a win for our surgeons and their patients, as well as a validation of thoughtful strategy by our global regulatory affairs team who utilized real-world clinical evidence gained from EU studies to show long-term safety and efficacy and secure the FDA approval for the smaller disc,” said Rebecca Whitney, global president of ZimVie Spine. “We are pleased to provide surgeons the largest range of footprint and height options in the market…