Endolumik Archives - Medical Design Sourcing

May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons

Endolumik’s illuminated device takes a big step for safety

The top orthopedic device news out of AAOS 2023

SaMD development lessons from Cordio’s voice AI heart failure app

Orthopedic device tech advances

High in the Wind River mountains of present-day Wyoming, the inhabitants of a remote alpine village — perhaps the oldest in North America — may have used fresh rawhide soaked in water as a splint to immobilize fractured bones thousands of years ago.

Before them, the ancient Egyptians used tree bark and linens, and native tribes of South Australia used thick clay.

They would all no doubt be amazed by the modern practice of orthopedics on display at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting — after they recovered from the shock of the scintillating sights of Las Vegas.

In this edition of Medical Design & Outsourcing, Executive E…

May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons

Endolumik’s illuminated device takes a big step for safety

The top orthopedic device news out of AAOS 2023

SaMD development lessons from Cordio’s voice AI heart failure app

Orthopedic device tech advances

High in the Wind River mountains of present-day Wyoming, the inhabitants of a remote alpine village — perhaps the oldest in North America — may have used fresh rawhide soaked in water as a splint to immobilize fractured bones thousands of years ago.

Before them, the ancient Egyptians used tree bark and linens, and native tribes of South Australia used thick clay.

They would all no doubt be amazed by the modern practice of orthopedics on display at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting — after they recovered from the shock of the scintillating sights of Las Vegas.

In this edition of Medical Design & Outsourcing, Executive E…

Endolumik’s illuminated device takes a big step for safety

The Endolumik Gastric Calibration Tube emits near-infrared light for enhanced visibility during bariatric procedures.

Endolumik’s story started a few years ago as the FDA sounded the alarm over the risks of internal surgical staplers.

In 2019, the federal agency warned healthcare providers that it had received more than 41,000 medical device reports (MDRs) related to surgical staplers and staples for internal use from 2011 to 2018. Those MDRs tallied more than 32,000 malfunctions, at least 9,000 serious injuries and 366 deaths.

Two years later, the FDA increased the risk level associated with the staplers, reclassifying the devices from Class I to Class II and subjecting them to premarket review and special controls.

Bariatric surgeon Dr. Nova Szoka had already been working on a device that could prevent some of those injuries. She envisioned an illuminated gastric calibration tube that …

FDA clears first device authorized under Safer Technologies Program

The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency’s Safer Technologies Program.

FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough devices program. The Safer Technologies Program (STeP) covers devices that could improve the safety of treatments or diagnostics. These are aimed at underlying diseases or conditions that are less serious than those eligible for the breakthrough program.

These devices should improve on existing diagnostics’ or treatments’ safety by reducing adverse events, device failures, use-related hazards or user errors or by improving the safety of other devices or interventions.

In a news release, the FDA said it intends for the program to offer patients more timely access. It does this by expediting product development, assessment and review. However, the FDA says it maintains its standards for safety and effectivenes…