Medtech AI developer Ketryx raises $14M in Series A round led by Lightspeed

NEWS RELEASE: Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners Investment fuels innovation to ensure patient safety and validate the use of AI in medical devices

BOSTON, Mass, December 5, 2023: Ketryx, provider of the first and only connected application lifecycle management software for the life sciences industry, today announced that it has raised $14 Million in Series A funding. The round was led by investor Lightspeed Venture Partners, with participation from existing investors including MIT’s E14 Fund and Ubiquity Ventures, bringing the total funding raised to date to over $18 Million. Lightspeed partner Guru Chahal will join the board. The new funds will be used to accelerate product development and commercial expansion.

The healthcare industry is embracing software and its promise to improve patient outcomes, including the power of Artificial Intelligence/Machine Learning (AI/ML). As a result, companies are grappling with how to main…

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Three steps for traceability in medical device software development quality and compliance

Many medical devices contain complex software and interdependencies with other software and hardware systems that weren’t designed to operate in a safety-critical environment. [Illustration via Adobe Stock]

A former FDA reviewer offers his perspective on building confidence in medical software validation.

By Paul Jones, Ketryx

When reviewing the software in software-as-a-medical-device (SaMD), software-in-medical-devices (SiMD) and systems-of-systems-of-medical-devices (SosMD) at the FDA, I was always looking for sufficient evidence to justify the sponsor’s claim that the device performs as intended — safely and effectively.

The arguments to support this claim are derived from the manufacturers’ quality management system (QMS) quality assurance, design controls, and corrective and preventative action (CAPA) process artifacts, which includes device distribution, post-market monitoring, and updates. Read more

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