Medical Design & Outsourcing

How listening, learning and leading won FDA de novo classification for Peytant

Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...
STAT

FDA clears spinal cord stimulator for home use

The FDA has cleared home use of a device that helps people with spinal cord injuries regain mobility and functioning.
Medical Device Network on MSN

FDA clears Onward’s ARC-EX System for home use in spinal cord injury care

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the expanded use of Onward Medical’s ARC-EX System ...
Endovascular Today

Vesalio Aspiration Devices FDA Cleared for Peripheral and Neurovascular Thrombectomy

Vesalio announced two FDA 510(k) clearances for its aspiration devices for peripheral and neurovascular applications, ...
JD Supra

From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System ...

Withings' smart thermometer is FDA-cleared - and checks more than your temperature

The smart thermometer performs a check-up on your body temperature, cardiac, and pulmonary health in less than a minute.
Jordan News Agency (Petra) on MSN

Eastern Military Region Intercepts Drug-Laden Balloons

The Eastern Military Region foiled a drug smuggling attempt early Thursday after spotting balloons loaded with narcotics and guided by primitive devices along its border. Border Guard forces tracked ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
STAT

Richard Pazdur, longtime cancer regulator, named drug center director at FDA

Pazdur replaces former Center for Drug Evaluation and Research Director George Tidmarsh, who exited the agency earlier this ...
Crain's Chicago Business

Local device makers win separate FDA OKs for spinal surgery tools

Two Chicago-area medical device companies announced federal clearances for their respective spinal surgery devices.
GlobalData on MSN

FDA grants label expansion for BrainsWay Deep TMS to treat MDD

The US FDA has granted 510(k) clearance, expanding the label of BrainsWay’s Deep Transcranial Magnetic Stimulation (TMS) ...

Spryte Medical Receives FDA IDE Approval to Initiate “INSYTE” US Pivotal Trial evaluating the nOCT Imaging System during Brain Aneurysm Treatment

INSYTE marks the first FDA-approved clinical trial of an intravascular optical imaging system designed specifically for the neurovasculature. The Spryte n OCT Imaging System uses high-resolution ...