Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...
TipRanks on MSN

Alpha Tau files first FDA PMA module for Alpha DaRT skin cancer therapy

An update from Alpha Tau Medical Ltd ( ($DRTS) ) is now available. On January 5, 2026, Alpha Tau Medical announced it has submitted the first ...
Zacks Investment Research on MSN

CapsoVision submits FDA 510(k) for AI-assisted module in CapsoCam Plus

CapsoVision, Inc. CV recently announced that it has submitted a 510(k) application to the FDA for approval to add an AI-based ...
Nasdaq

Natera Submits First PMA Module to the FDA for Signatera™

Lays groundwork for multiple submissions across cancer types, starting with CDx label in bladder cancer This module, submitted on September 28, included the required documentation regarding Natera’s ...
Business Wire

FDA Grants Clearance for SPECTRALIS Flex Module, Expanding Access to Advanced Multimodal Ophthalmic Imaging for Underserved Patients

FRANKLIN, Mass.--(BUSINESS WIRE)--Heidelberg Engineering, a global leader in ophthalmic imaging and healthcare data solutions, announces FDA clearance of the SPECTRALIS ® Flex Module. This innovative, ...
Healio

Heidelberg receives FDA clearance of imaging platform module

Please provide your email address to receive an email when new articles are posted on . Heidelberg Engineering obtained FDA clearance of its Spectralis Flex Module imaging platform, according to a ...
Healio

FDA clears Epithelial Thickness Module for Anterion imaging platform

Please provide your email address to receive an email when new articles are posted on . The Epithelial Thickness Module adds advanced thickness mapping and data insights. Ectasia View is also ...

CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus®

Company Preparing to Commence Commercialization Following U.S. FDA 510(k) ClearanceSARATOGA, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical ...
The National Law Review

FDA Updates CFSAN Online Submission Module (COSM)

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
BioWorld

FDA clears Artrya’s Salix AI coronary plaque module

The U.S. FDA has cleared Artrya Ltd.’s 510 (k) for its Salix Coronary Plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.
Business Wire

Natera Submits First PMA Module to the FDA for Signatera™

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the submission of the first module of its premarket approval (PMA) application to ...