FDA Hikes Premarket Application User Fees by 2.5 Percent

Applying for FDA premarket review of medical devices will be more expensive next year. On Aug. 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]

Industry Trends

Investors Sink Nearly $15 Billion into Digital Health Companies in First 6 Months of 2020

The pandemic has enabled developers of Electronic Health Record (EHR), Laboratory Information Systems, ePrescription software and other digital health technologies to attract investment capital at … [Read more...]


5 Unintended Ways Companies Compromise Their Network Security

By Ron Slyker Solid organization security is a considerable necessity in today’s world, that is not going to come as a surprise to anyone. Nonetheless, making and keeping an impenetrable … [Read more...]

Compliance Perspectives

Beware of Privacy Pitfalls When Remotely Monitoring Lab Telecommuters

Before the pandemic, 80 percent of U.S. employees worked primarily from an external workplace; today, only 21 percent do. Coaxing employees to return to the workplace will be an uphill battle, with … [Read more...]

Emerging Tests

Technological Breakthroughs: NASA Begins Testing of Handheld COVID-19 Breathalyzer Device

A portable, handheld, easy-to-use breathalyzer device capable of accurately detecting the SARS-CoV-2 at the point of care would represent a game changer for COVID-19 diagnostics. And while inventing … [Read more...]


MCIT Medicare Coverage Rule Could Be Reimbursement “Breakthrough” for Makers of LDTs

Medical device makers and members of Congress are growing impatient as CMS sends signals of still further delay on a final decision on a final rule that would automatically provide initial Medicare … [Read more...]


Getting Medicare Reimbursement for Telehealth Lab Services: The New CONNECT for Health Act

Like most cliches, the one about the COVID-19 pandemic’s transformation of medicine forever is laden with truth. Telemedicine is Exhibit A. Of course, telemedicine goes back decades. But the pandemic … [Read more...]

Technology & Innovation

CMS Delays New Rule Providing Automatic Medicare Coverage of Breakthrough Devices

A CMS final rule providing for automatic Medicare coverage for new medical products cleared by the FDA as breakthrough devices under Section 510(k) was supposed to take effect on March 15, 2021. But … [Read more...]


Are you keeping your email compliant with HIPAA?

By Ron Slyker bio If you are a lab manager, you have more than likely heard the term “HIPAA compliance." Most relate it to the protection of patient health information (PHI) within the office, but … [Read more...]

Emerging Tests

The Evolving COVID-19 Market: FDA Clears the Way for Asymptomatic Screening Products

A year after it came into being, the market for coronavirus diagnostics is dramatically evolving with the focus of growth inevitably shifting to products designed for serial screening of the … [Read more...]