Device Pipeline & Approvals

The approval is based on results from the admIRE study, which showed 100% of atrial fibrillation patients achieved acute procedural success.

Tarver takes over the lead role at CDRH after serving as interim director since July.

FDA approval of Optune Lua follows the Phase 3 LUNAR trial, showing significant improvement in median overall survival for metastatic NSCLC patients.

The decision will not impact the device’s FDA clearance for other indications.

The system will be part of a NPH study.

Limaca Medical’s device had previously received a breakthrough device designation from FDA.

The device used a headset with a virtual display to provide information to surgeons during procedures.

This will allow the product to arrive in hospitals at a faster pace.

The technology, created by IceCure Medical, freezes tumors and is an alternative to surgical intervention.

The device is described as a motor-robotic prosthetic knee.

The FDA granted 501(k) clearance to Fresenius’ Versi HD with GUideMe Software. The device will be available in select markets at some point in 2023, and previous models will be upgradeable.

A new report details the factors expected to drive the market’s growth in the coming years.

The non-invasive device can be used to monitor the heart in a variety of ways.

The devices will be available commercially in October 2023.

The treatment is for a major depressive disorder.

Motive Health Inc. announced the Motive Knee.

The assay, developed by Abbott Laboratories, is used to detect the hepatitis B surface antigen.

McDonough speaks with MDT about ChromaCode’s HD PCR technology and the company’s recent expansion to India and the Middle East.

Peripheral neurostimulator for tibial nerve stimulation for incontinence treatment is delivered through an implantable device.

A recent report details the steady growth of AI and machine learning.

These devices help maintain the natural order of the eye during the surgery.

MDT spoke with Harbison about the technology used at the 80th Street Residence in NYC that helps monitor the symptoms of patients with cognitive issues.

The trials are focused on a device which reportedly provides relief to migraine related pain and other symptoms.

New interactive tool, other resources help use regulatory strategy to drive successful business strategy for digital medical product development

Alira Health and MassMEDIC collaborated on the report.

The improvement of blood analysis technology and the dawn of decentralized trials have prompted development of at-home sampling products that draw from a capillary.

Pandemic and supply shortage among factors in slow transition to new rules.

Data shows patients don't always know they are having AF symptoms, bolstering need for continuous monitoring.

ClariMed formed to provide pharma and medical device manufacturers an integrated, human-centric approach to medical product development and is headed by CEO Kelley Kendle.

A Scottish-based research group has developed a stent-graft combination for Type A dissection, which studies show greatly improved survival rate.