The U.S. Food and Drug Administration (FDA) released a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” This document outlines a Total Product Lifecycle (TPLC) approach to manage and market AI-enabled medical devices, addressing the unique challenges and risks of AI technologies. Comprehensive Guidelines for AI-Enabled Devices The FDA’s ..read more

*PRESS RELEASE* Complementary product portfolio and broad footprint of production sites in Europe Strengthening the market position as a full-service provider for the pharma and biotech industry Strategic reset of Moulded Glass business Düsseldorf, December 11, 2024 – Gerresheimer, an innovative systems and solutions provider and global partner for the pharma, biotech and cosmetics industries ..read more

*PRESS RELEASE* CHICAGO – December 10, 2024 – ConTIPI Medical, an innovator in providing non-surgical and disposable solutions for women with various pelvic floor dysfunctions, and EVERSANA, a leading provider of global commercial services to the life sciences industry, today announced the United States commercial launch of ProVate to help women experiencing pelvic organ prolapse (POP).   ProVate, a ready-to-use ..read more

Improved data delivery, intelligent document processing, now available to Exa Platform usersSEATTLE--(BUSINESS WIRE)--Concord Technologies (“Concord”), a leading provider of Secure Document Exchange, Intelligent Document Processing, and Interoperabili ..read more

BILTHOVEN, Netherlands & BOSTON--(BUSINESS WIRE)--Avania, the leading global MedTech advisory and clinical development partner, today announced the appointment of operational strategy expert Charlene Dark as chief operating officer (COO). Dark brings o ..read more

AllurionMeds is designed to address a critical demand from patients: The Weight Must Stay Off Features Coach Iris, a first-of-its-kind conversational AI behavioral agent for weight loss and maintenance, trained using real-world experience in over 150 ..read more

At the recent Frontiers Health conference, Nicole Raleigh, web editor at pharmaphorum, had the opportunity to sit down with Marcus Bates, Vice President and Head of Global Business Development and Global Head of Respiratory at Aptar Digital Health. Their discussion delved into the evolving landscape of digitally augmented therapies and the strides Aptar Digital Health ..read more

LAS VEGAS--(BUSINESS WIRE)--#accelerator--On November 14th, the Consumer Technology Association (CTA) announced the honorees of the CES 2025 Innovation Awards®. The Japan External Trade Organization (JETRO) will once again sponsor the Japan (J-Startup ..read more

The funding, led by Windham Capital Partners, will further fuel TailorMed’s mission to eliminate barriers to care for millions of patientsNEW YORK--(BUSINESS WIRE)--#digitalhealth--Today, TailorMed, a leading innovator in healthcare technology, announ ..read more

Move PT combines applied AI, computer vision, and remote therapeutic monitoring to deliver intelligent, data-driven rehabilitation across clinical and home environmentsDALLAS--(BUSINESS WIRE)--Academy Medtech Ventures (AMV) is thrilled to announce the ..read more