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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.
Spryte Medical Receives Breakthrough Device Designation from FDA for Revolutionary neuro Optical Coherence Tomography (nOCT) Technology
“Our engagement with the FDA through the Breakthrough Device and Total Product Life Cycle Advisory Program (TAP), highlights the potential of Spryte Medical’s neuro OCT imaging platform for patients with cerebrovascular disease” said David Kolstad, Chief Executive Officer of Spryte Medical. “We look forward to working collaboratively with the FDA for the benefit of these patients.”
eCential Robotics Receives FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device
"This additional FDA clearance is a testament to our relentless pursuit of innovation and excellence in the field of surgical robotics and navigation," said Clément Vidal, CEO at eCential Robotics. "We look forward to continuing to deliver cutting-edge solutions that enhance surgical precision and patient outcomes."
Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive...
“The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the U.S.,” said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. “The FDA’s granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate. We continue to work closely with the Pierre Fabre Laboratories team to help prepare for the potential launch in the U.S. in early 2025, along with the potential label expansion multicohort Phase 2 EBVision trial.”
FDA Approves Roche’s Vabysmo Prefilled Syringe for 3 Leading Causes of Vision Loss
Vabysmo prefilled syringe is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness.
Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA
Genio is a different approach to hypoglossal nerve stimulation (HGNS). Genio offers patients a leadless, fully-body MRI compatible, non-implanted battery solution, powered and controlled by a wearable.
FDA Approves PYZCHIVA ® (ustekinumab-ttwe), Samsung Bioepis’ Biosimilar to Stelara
“The FDA approval of PYZCHIVA as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments,” said Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “In addition, biosimilars have a potential to reduce the financial burden of healthcare systems, especially in the US where biologics account for more than 46% of the annual drug spending. We will continue to reinforce our commitment to widen access to medicines by advancing our biosimilar pipeline for the benefits of patients, healthcare providers, and healthcare systems around the world,” she added.
Neuromod Partners with 14 New US Tinnitus Clinics to Expand Availability of FDA Approved Lenire
Lenire has become the most in-demand tinnitus treatment device in America since the device was awarded a De Novo FDA Approval Grant in 2023. Neuromod Devices, creators of Lenire, is operating a phased expansion to prioritize patient care excellence at scale.
AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System
AlivCor notes this is the world’s first AI that can detect life-threatening cardiac conditions, including heart attacks, using a reduced leadset. The Kardia 12L ECG System, featuring a game-changing patented technology, is the world’s first AI-powered handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design.
Endotronix Receives FDA Premarket Approval of the Cordella PA Sensor System for the Treatment of Heart Failure
Cordella, which consists of the now PMA-approved Cordella PA Sensor and commercial Cordella™ HF System, enables comprehensive heart failure management in the home using pulmonary artery (PA) pressure, a leading indicator of congestion, and non-invasive vital sign data to improve care decisions. Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the company is planning a U.S. launch of Cordella this year.