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U.S. flag, stethoscope

Cook’s Echo Tip comes up short in Medicare outpatient final rule, but Philips’ Cavaclear scores

Nov. 7, 2023
By Mark McCarty
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The U.S. Centers for Medicare & Medicaid Services (CMS) has wrapped up its rulemaking for the outpatient prospective payment system (OPPS) for calendar year 2024, bringing some good news and some bad news for the medical device industry. While Philips North America came home with a new technology pass-through (NTPT) payment for its Cavaclear device, Cook Medical Inc., was less fortunate with its Echo Tip device as CMS declared that the Echo Tip did not satisfy the substantial clinical improvement criteria for transitional pass-through payment.


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U.S. Capitol building
FDLI Advertising and Promotion Conference

US data privacy environment a tangled web for med-tech companies

Nov. 3, 2023
By Mark McCarty
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Privacy considerations have been front and center for U.S. federal government agencies for more than two decades, but several states have jumped into the privacy arena with their own legislative imperatives. While companies in the medical device industry would like to see a less imposing thicket of related enforcement requirements, Nancy Perkins of Arnold & Porter LLP said there is little prospect that Congress will relieve the predicament with anything resembles preemptive legislation.
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Sickle cell illustration

Adcom: Don’t sacrifice progress for perfection

Nov. 1, 2023
By Mari Serebrov
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Had it been asked to, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee would have voted Oct. 31 to recommend approval of Vertex Pharmaceutical Inc. and Crispr Therapeutics AG’s exagamglogene autotemcel, or exa-cel, as a one-time transformative treatment for severe sickle cell disease in individuals 12 and older.
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Head filled with digital data

Biden administration seeks info on AI algorithms

Oct. 31, 2023
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The Biden administration has issued an executive order (EO) for artificial intelligence (AI), which addresses not only national security considerations, but public health considerations as well. One of the features of the EO is that any company developing AI for public health and safety must notify the federal government when training a foundation AI algorithm, which suggests that AI that is regulated by the U.S. FDA will now be subject to additional government scrutiny in the premarket phase.
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