Medical Device and Diagnostic Industry (MD+DI)

Two Key Medical Device Leaders Ditch FDA

FDA loses two key leaders as Jessica Paulsen departs Digital Health Center and David McMullen joins Neuralink amid staffing challenges.
STAT

Key digital health and device leaders depart FDA

Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of neurological and physical medicine devices, which is in charge of regulating ...
Becker's Spine Review

Spine implants, tech earning FDA nods in 2025

Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...

ProMed Delivers Proven Expertise in Contract Medical Manufacturing for Medical Device and Pharma Companies

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...
ExecutiveGov

FDA Seeks Feedback on Venture Capital-Backed Contract Model

The FDA issued an RFI seeking venture capital input on a new contract model to connect portfolio companies directly with ...
Medical Device Network on MSN

Edwards receives FDA approval for mitral valve replacement system

Edwards Lifesciences has received the US Food and Drug Administration (FDA) approval for its SAPIEN M3 mitral valve ...
Hosted on MSN

As FDA slashes workforce, number of new medical devices reaching the public has fallen

MINNEAPOLIS — U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs ...
MD&M East

FDA Expands Medical Device Recall Alert Program

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...

Contract Manufacturing of Medical Devices Global Markets Report 2025-2030: Growth Driven by Aging Populations, Rising Chronic Disease Burden, and OEM Shift Toward ISO- and FDA ...

The global market for contract manufacturing of medical devices is estimated to grow from $96.4 billion in 2025 to reach $155.2 billion by 2030, at a compound annual growth rate (CAGR) of 10% from ...