Category:
FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Silk Road Medical Announces FDA Approval of Expanded Indications for the ENROUTE® Transcarotid Stent System
Previously, the stent was approved for use only in patients with anatomic or physiological criteria that put them at high risk of complications from more invasive surgical procedures advises Silk Road Medical.
CoNextions TR® Tendon Repair System Receives FDA Clearance
Studies have demonstrated the CoNextions TR enables a stronger, faster and smoother repair of tendon lacerations.
SMART Medical Systems Reports G-EYE® Colonoscope Is Now FDA Cleared on Olympus’ PCF Colonoscope Series
SMART Medical Systems CEO said, "The ability to offer G-EYE® on colonoscope brands and models commonly used and widely available in the United States is an important milestone for SMART Medical, patients, and endoscopists."
SonoScape Receives FDA 510(k) Clearance for HD-550 Endoscopy System
SonoScape notes the HD-550 endoscopy system has been available outside of the USA since 2019.
Alio Remote Monitoring Technology Receives First FDA 510(k) Clearance
Alio takes steps toward making better chronic care management a reality
Pear Therapeutics Receives Safer Technologies Program (STeP) Designation from FDA for Product Candidate to Treat Acute and Chronic Pain
Pear Therapeutics: Pear-010 is a PDT candidate intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain.
Aidoc Delivers the Most Comprehensive Neuroscience Package for AI-driven Coordination with New FDA 510(k) Clearance for Brain Aneurysm
Aidoc Co-found Elad Walach said, “We’re excited to include this algorithm in our set of neuro solutions, addressing the challenge of providing timely and accurate notifications of brain aneurysm cases. With this 9th FDA clearance in three years, we stay committed to providing the most comprehensive platform in the space.”
Zenith Thoraco+ Endovascular System Receives FDA Breakthrough Device Designation
The Thoraco+ is built on the strength of the proven Zenith platform and represents a next-generation endovascular graft for the treatment of thoracoabdominal aortic aneurysms.
Aidoc Expands AI Service to X-ray, Receiving FDA 510(k) Clearance for Pneumothorax
Aiodic advises their 8th solution to be cleared spearheads the company's AI-driven X-ray package.
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