CorTec gains FDA breakthrough designation for stroke rehabilitation BCI

CorTec's BCI aims to differentiate itself by offering brain-based communication alongside therapeutic neurostimulation.

Pulse Biosciences: Promising Catheter Technology, Weak Risk-Reward For Now

Pulse Biosciences (PLSE) highlights promising AFib catheter data and IDE-cleared pivotal trial progress—plus thyroid ...

Drs. Todd H. Lanman and Joel S. Beckett Perform First Clinical Case Using Newly FDA-Approved Synergy Disc(R)

Beverly Hills spine surgeons complete three-level cervical disc replacement following recent FDA approval of ...
InvestorsHub on MSN

Adagio Medical secures FDA clearance to broaden ventricular ablation study

Adagio Medical Holdings Inc. (NASDAQ:ADGM) said it has received Investigational Device Exemption (IDE) authorization from the ...
MassDevice

Adagio Medical wins FDA IDE to expand ventricular ablation study to use next-gen catheter

Adagio Medical (Nasdaq:ADGM) announced today that it received FDA investigational device exemption (IDE) to expand its ...

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation — the First BCI Worldwide Designated for Stroke Motor Rehabilitation

CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the ...
The Bakersfield Californian

Adagio Medical Receives IDE Approval from the FDA to Investigate Next-Generation vCLAS® Ventricular Ablation System

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that the U.S.
Medical Device and Diagnostic Industry (MD+DI)

Pulse Biosciences Latest Milestone Helps It Be Heard in Noisy PFA Market

Pulse Biosciences is keeping the noise level up by announcing the enrollment of the first patients in the NANOPULSE-AF study, a prospective, multicenter, IDE pivotal clinical investigation currently ...

TRiCares gains FDA IDE to initiate tricuspid regurgitation treatment pivotal trial

TRiCares' pivotal trial will build on an ongoing early feasibility study of the Topaz TTVR system that began in January 2025.
MassDevice

Pulse Biosciences enrolls first patient in IDE study for PFA tech

Pulse Biosciences (Nasdaq:PLSE) announced today that it enrolled the first patients in its NANOPULSE-AF study.
InvestorsHub on MSN

Artivion secures FDA approval for NEXUS aortic arch device, weighs Endospan acquisition

Artivion Inc. (NYSE:AORT) said the U.S. Food and Drug Administration has approved the premarket application for the NEXUS ...

TRiCares Receives FDA Approval for TRICURE US IDE Pivotal Trial with the Topaz Tricuspid Valve Replacement System

Minneapolis, MN, USA and Paris, France and Munich, Germany, 7 April 2026 – TRiCares SAS (“TRiCares”), a privately held pioneer in the field of ...