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 ...
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 ...
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 ...
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, ...
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 ...
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 ...
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.