Regulatory Affairs Professionals Society

FDA drafts guidance on using next-generation sequencing to assess gene therapy safety

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...

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 ...

Stereotaxis Announces FDA Clearance and Launch of Synchrony System

ST. LOUIS, April 06, 2026 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has ...
Morning Overview on MSN

Elon Musk says Neuralink users could control Tesla Optimus robots

Elon Musk has suggested that people with Neuralink brain implants could one day control Tesla’s Optimus humanoid robots using ...

Stereotaxis, Inc.: Stereotaxis Announces FDA Clearance and Launch of Synchrony System

Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has ...
Zacks Investment Research on MSN

GEHC unifies bkActiv with Stealth AXiS for live neurosurgery imaging

GE HealthCare Technologies Inc. GEHC recently announced a digital integration between its bkActiv intraoperative ultrasound ...

FDA declines to issue specific guidance on health programs' foreign drug imports

A CNBC investigation revealed the proliferation of AFPs, which import prescription drugs from overseas in what U.S.
News-Medical.Net

FDA clears investigational new drug application to test sCAR-T therapy for autoimmune conditions

Calibr-Skaggs Institute for Innovative Medicines, the drug discovery division of Scripps Research, announced today that the ...
Medical Device and Diagnostic Industry (MD+DI)

How to Safely Navigate the New QSMR & Succeed with FDA Inspections

Kim Trautman, an industry expert, shares some practical tips and tools for companies to navigate FDA’s new inspection process ...
Regulatory Affairs Professionals Society

FDA budget proposal: New clinical trial pathway; permanent authorization of rare pediatric disease voucher program

The US Food and Drug Administration (FDA) has submitted its budget proposal to Congress, outlining its spending priorities ...

FDA to review whether to allow more access to certain peptides

The U.S. Food and Drug Administration (FDA) will soon review whether certain peptides should be allowed in customized ...