Allogene Therapeutics Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune Diseases
Best-in-Class Design to Enhance Therapeutic Benefit and Expand Treatment Potential Across a Range of Autoimmune Disease Indications; Inno ...
ClearPoint Neuro announces FDA clearance for ‘Navigation Software Version 3.0’
ClearPoint Neuro (CLPT) announced it has received 510 clearance for its ClearPoint Navigation Software Version 3.0. “As we prepare for the wave ...
Food Safety News2d
FDA warns bakery for food safety violations, including sanitation and allergen control failures
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or ...
AI Optics Receives FDA Clearance, Increasing Patient Access to Retinal Screening
AI Optics Inc., an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its Sentinel Camera. This handheld retinal imaging system captures high-quality ...
Food Safety News6d
Government Accountability Office finds problems with FDA inspection rates
In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities is understaffing. The Food and Drug ...
News Medical on MSN1d
Innovating for impact: Jordi Labs on aligning methodologies with FDA expectation
News-Medical speaks with Jordi Labs’ about its recent achievements, alignment with FDA expectations, and strategic ...
Healio12h
Lynx ophthalmoscope launches with FDA clearance, CE mark
Lynx, Norlase’s pattern scanning laser indirect ophthalmoscope, commercially launched with both FDA 510(k) clearance and a CE ...
NBC News6d
Federal regulations paused, halting FDA's proposed ban on formaldehyde in hair products
Not all chemical hair relaxers include the chemical, but many include ingredients that can release formaldehyde when heated, the FDA said in 2024. Over the years, an increasing number of studies ...
News Medical on MSN6d
Insilico Medicine doses first patient in Phase I Trial of ISM6331 for mesothelioma
Insilico Medcine( "Insilico") , a clinical stage generative artificial intelligence (AI)-driven biotechnology company today announced the first patient has been dosed in the global multicenter Phase I ...
Yahoo Finance3d
FDA Clears World's First Mobile App for Contactless Pulse Rate Measurement
This FDA clearance represents a significant milestone in PanopticAI's mission to make healthcare more accessible and scalable. By leveraging the ubiquity of smartphones, PanopticAI's technology ...
ophthalmologytimes1d
Norlase receives FDA 510(k) clearance and CE mark for LYNX pattern scanning laser indirect opthalmoscope
The company states LYNX is the world’s first and only pattern scanning laser indirect ophthalmoscope and is battery-powered ...
Yahoo Finance3d
FDA Clears World's First Mobile App for Contactless Pulse Rate Measurement
This FDA clearance represents a significant milestone in PanopticAI's mission to make healthcare more accessible and scalable. By leveraging the ubiquity of smartphones, PanopticAI's technology ...