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FDLI Advertising and Promotion Conference

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

Nov. 3, 2023
By Mark McCarty
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
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
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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AI dollar sign

Ametek treats shareholders with $1.9B Paragon acquisition

Oct. 31, 2023
By Annette Boyle

There’s nothing scary for Ametek Inc. shareholders in the $1.9 billion acquisition of Paragon Medical Inc. announced on Oct. 31, 2023. The deal moves the industrial technology company solidly into the med-tech space as it picks up Paragon’s portfolio of products in orthopedics, minimally invasive surgery, robotic surgery and drug delivery, and adds an estimated $500 million per year in revenue and “very strong EPS accretion,” Ametek CEO David Zapico said in an investor call on Oct. 31.


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US Centers for Medicare & Medicaid Services ups base ESRD rate from draft rule

Oct. 31, 2023
By Mark McCarty

The U.S. Centers for Medicare & Medicaid Services (CMS) has released the prospective payment rule for end-stage renal disease (ESRD) for calendar year 2024, and advocates had some luck prompting the agency to boost the base ESRD payment rate. However, Atlanta-based Pain Care Labs Inc. came up short in its transitional add-on payment application for the Buzzy Pro for relief of puncture wound site pain because, according to CMS, the device does not represent a substantial improvement over currently available remedies.


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Olympus recalls UHI-4 high flow insufflation devices

Oct. 31, 2023
By Mark McCarty
Olympus Medical Corp. instituted a class I recall of its UHI-4 high flow insufflation device due to reports that the device may over-inflate and potentially create embolisms. The recall affects more than 3,100 units distributed in the U.S. between May 2012 and August 2023, all of which should not be used until the company resolves the problem.
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