Kevin O'Leary Reveals How Elites Use a Procedure Not Approved by the FDA for Rapid Cell Regeneration

Shark Tank star Kevin O'Leary recently shared how he undergoes an exotic procedure for rapid cell generation, tissue healing, ...
Medical Device and Diagnostic Industry (MD+DI)

Intuitive’s da Vinci 5 Secures FDA Cardiac Clearance

Intuitive Surgical receives FDA clearance for the da Vinci 5 robot to be used in cardiac procedures, reports 18% procedure ...

Phraxis Announces First Post-Approval Study Procedure with EndoForce™ Anastomotic Connector at Spartanburg Regional Healthcare System

Phraxis Inc. today announced the successful initiation of its Post-Approval Study (PAS) for the EndoForce™ Anastomotic ...
MPR

iDose TR Labeling Expanded to Include Repeat Treatment Procedures

Results from the iDose TR exchange trial showed a second administration and removal of the original implant was safe and well tolerated over 12 months.
Medical Device Network on MSN

Intuitive receives FDA clearance for non-force feedback instruments in cardiac procedures

Intuitive CEO Dave Rosa highlighted that the clearance related to “several cardiac” procedures for non-force instruments used ...
optics.org

Leadoptik announces FDA approval for lung biopsy procedures

According to Leadoptik's FDA application, the LIA catheter is an OCT-guided biopsy needle designed for use with endobronchial ...
JD SupraOpinion

New FDA Approach to Drug Prices Adds Uncertainty to Drug Approval Process

In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an ...
Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
Hosted on MSN

New medications coming soon: Here’s what’s been FDA approved in 2025 so far

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...
BioSpace

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.