Fda

FDA QMSR ties supplier contracts to inspection prep

FDA’s QMSR is pushing medtech OEMs to rewrite how CMOs handle risk, records, and audit support.

Interchangeable biosimilars cut drug spend only when pharmacies can actually switch them

FDA interchangeable biosimilars are expanding beyond insulin, pushing payer and pharmacy ops teams to tighten substitution rules, EHR signals, and inventory pla

Rasonque’s 13.2-month survival result is about to hit hospital formularies

FDA cleared Revolution Medicines’ Rasonque for metastatic pancreatic adenocarcinoma. The ops work now is pathways, genotyping, and specialty pharmacy flow.

FDA’s Oct. 19 AI docket forces medtech teams to write tests, not slide decks

The FDA’s generative AI discussion paper points to competency-style evaluation and heavier postmarket monitoring, pushing vendors and hospital buyers to demand

Medicare's ACCESS pilot is live, but patients can't find which providers offer it

CMS launched its tech-enabled chronic care pilot and the FDA's AI device authorizations hit 115 in 2021, yet a critical gap remains: patients don't know where t

FDA-authorized digital medical devices have grown substantially over two decades, but regulatory databases still can't track them

A Nature study finds digital device authorizations have surged over 20 years, yet FDA databases still can't identify which devices have software inside.

Gene therapies, early detection, and GLP-1 drugs are reshaping enterprise healthcare procurement

From FDA-cleared gene therapy for toddlers to blood tests predicting Alzheimer's onset, health advances are accelerating benefit plan and procurement decisions.

FDA clears UpDoc's LLM diabetes app, grants Aidoc breakthrough status as clinical AI crosses new regulatory thresholds

UpDoc gets FDA clearance for an LLM-driven diabetes management app; Aidoc earns breakthrough device status for AI-drafted radiology reports.

OpenLoop acquires AI communication platform Hey Revia as digital health M&A heats up

OpenLoop's acquisition of Hey Revia, FDA breakthrough status for Aurenar, and Sharecare's AWS tie-up headline a busy week in digital health.

GE HealthCare receives FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, advancing AI-enabled radiation therapy planning with expanded clinical capabilities

Marking the evolution of MIM AI-enabled auto-contouring software, MIM Contour ProtégéAI+ 2.0 introduces new models, including a Magnetic Resonance (MR) Brain model, as well as an updated Computed Tomography (CT) Male Pelvis model, expanding clinical capabilities across key anatomical regions.

From Monitoring to Knowing: How Owlet Is Redefining Infant Health at Retail

Baby monitors have long promised parents the ability to see and hear their child from another room. But as connected health devices become more normalized in everyday life, from smartwatches to sleep trackers, parents are beginning to expect more than visibility. They want insight. For Owlet, that shift matters because its wearable monitors track…

Verified, Tested, Trusted: How Corganics Ensures THC-Free Confidence in Clinical CBD

Corganics is redefining standards in clinical cannabinoid care with THC-free, medical-grade CBD products developed for use exclusively by healthcare professionals. Backed by Advanced Lipid Technology, FDA-registered manufacturing, and rigorous third-party testing, Corganics offers a level of trust and transparency rare in the CBD space. In a conversation with Reggie Gatewood, President of Corganics, Brooke Williams,…

Corganics’ Clinical CBD Drops: Elevating Sleep and Patient Care at Beautiphi

Corganics’ Clinical CBD Drops—THC-free, medical-grade, and developed with Advanced Lipid Technology—are designed for healthcare professionals seeking a trusted, science-backed cannabinoid solution for their patients. Manufactured in an FDA-registered facility and third-party lab-tested, these drops are a cornerstone of Corganics’ clinical approach. At Beautiphi Aesthetic Boutique, founder Kelly Hermans, CRNA, has integrated the drops into patient…

Shaping the Future of Cancer Care Through Immuno-Oncology

Combination therapies and emerging cell-based treatments are reshaping how oncologists tackle cancer at the cellular level

BioMark Bags™: FDA-Compliant and Customizable Bioprocessing Bags for Secure Fluid Handling

Single-use bioprocessing bags engineered with multi-layer protection and modular design options help manufacturers meet strict regulatory standards while stream

Health Plans are Now Covering New Weight Loss Drugs. This Can Help Fix the Obesity Epidemic

Widespread insurance coverage of breakthrough weight loss medications could redirect billions in healthcare spending from treating obesity-related diseases to p