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The medical device startup is focused on addressing significant unmet needs of patients suffering from corneal blindness around the world...

(Archived document, may contain errors) How We Are Regulating Ourselves Out of Business

ECRI has been publishing its annual report of health technology hazards for the past 15 years. According to ECRI’s Device Evaluation group, the Top 10 Health Technology Hazards list identifies the potential sources of danger that we believe warrant the greatest attention.

In this column, in the coming months we are going to dig into the data regarding FDA regulation of medical products, deeper than the averages that FDA publishes in connection with its...

  SANTA CLARA, Calif., July 21, 2021 /PRNewswire/ -- Axon Therapies, a private company focused on addressing a root cause of heart failure, today announced the appointment of seasoned medical device executive Chad Hoskins as Chief Executive Officr (CEO). Mr. Hoskins will lead the company as it transitions from early development towards regulatory clearance and commercialization of its novel heart failure treatment, splanchnic ablation for volume management (SAVM), using the Satera™ Ablation ...

MCRA Expands its Cardiovascular Division, Hiring Fernando Aguel, Former Assistant Division Director, FDA Circulatory Support Devices News provided by Share this article Share this article WASHINGTON, May 20, 2021 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating US and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce the hiring of Fer...

Basil Systems Launches Commercial Platform While Securing $1.5M in Seed Funding Share Article BOSTON (PRWEB) March 16, 2021 Basil Systems publicly released the commercial version of its SaaS platform while announcing the company’s first funding round which will be used to accelerate growth. Basil is a healthcare-focused start-up delivering a comprehensive system for the medical device and pharmaceutical industries, helping comp...

Those fever scanners that everyone is using to fight covid can be wildly inaccurate, researchers find Drew Harwell © Ahn Young-Joon/AP A thermal scanner shows the estimated body temperatures of travelers in Seoul. Temperature-scanning devices that check for fevers in schools, workplaces and public venues across the United States distort the results in a way that could overlook the telltale sign of a coronavirus infection, according to new research that casts doubt on the syst...

A flood of thermal scanners hit the market last year. But researchers say many of the devices use software that can make a feverish person appear perfectly well.