Regulatory & Compliance

Can FDA Regulate Laboratory Developed Tests Effectively?
Regulatory & Compliance Can FDA Regulate Laboratory Developed Tests Effectively?

In the realm of modern healthcare, the intersection between technology, regulation, and practice is both complex and crucial. James Maitland, a renowned expert on IoT applications and robotics in medicine, is here to share his insights on these evolving areas. With recent debates around laboratory

Can Congress Avert Medicare's Financial Crisis by 2033?
Regulatory & Compliance Can Congress Avert Medicare's Financial Crisis by 2033?

In this captivating exploration into the financial challenges facing Medicare, we're joined by James Maitland, a distinguished expert in healthcare policy. With Medicare's hospital insurance trust fund projected to run out of money by 2033, three years sooner than previously expected,

How Will FDA's MDUFA VI Transform Medical Device Regulation?
Regulatory & Compliance How Will FDA's MDUFA VI Transform Medical Device Regulation?

In a rapidly evolving medical device industry, the upcoming Medical Device User Fee Amendments VI (MDUFA VI) holds the promise of transformative change. Positioned as a vital component in the regulatory landscape, MDUFA VI is set to redefine the dynamics of device regulation through strategic

Can RFK Jr. Reshape Vaccine Policy Amid Controversy?
Regulatory & Compliance Can RFK Jr. Reshape Vaccine Policy Amid Controversy?

In today's interview, we dive into the monumental changes happening within the CDC’s vaccine recommendation committee. We are joined by James Maitland, though not directly involved, his insights into regulatory and policy changes are incredibly valuable due to his extensive expertise in t

Oregon Enacts Strict Law Against Private Equity in Healthcare
Regulatory & Compliance Oregon Enacts Strict Law Against Private Equity in Healthcare

In a time when the role of private equity in healthcare is under intense scrutiny, Oregon's recently signed law represents a significant regulatory shift aimed at preventing non-physician investments in medical practices. To unpack the complexities and implications of this law, we spoke with

Medtronic Recalls Ventilators After Faults Cause Injuries, Death
Regulatory & Compliance Medtronic Recalls Ventilators After Faults Cause Injuries, Death

The medical device industry, encompassing areas like ventilators, plays a crucial role in modern healthcare by providing essential technologies that sustain life. Recent developments regarding Medtronic's decision to recall over 4,800 ventilators illuminate persisting challenges within this

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