A Quick Look at a Critical FDA Discussion Paper

It seems a good time to update everyone on the FDA discussion paper for autonomous and remote teleoperation surgical systems. There’s a lot in this paper that I won’t go into here, but here are a few matters worth mentioning. First, the FDA’s Center for Devices and

DCBs Putting the Squeeze on DES in Coronary Artery Stenosis

The drug-eluting stent (DES) has dominated the world of device treatment of treatment-naive coronary artery stenosis for two decades, but a study unveiled Nov. 1 may help erode that dominance. One-year data from the TRANSFORM II study suggests that drug-coated balloons (DCBs) may be appropriate for

Industry Waiting for Clarity over Delegation of OIG Authorities

(Posted Oct. 19, 2026, on LinkedIn) BOSTON – The news that the Centers for Medicare & Medicaid Services now has authority to exclude life science entities from federal health programs wasn't entirely unexpected, thanks to hints dropped by HHS in July 2026. However, Chris White, general counsel at the

The Interesting Saga of the Left Atrial Appendage Closure Device

(Posted Sept. 29, 2026, on LinkedIn) Devices for closure of the left atrial appendage (LAA) have a fascinating history to say the least. These devices have undoubtedly thwarted a large number of strokes in patients with non-valvular atrial fibrillation, but the pharmaceutical industry has moved on from legacy oral

A Blast From the Past: FDA's Recurring Commercial Speech Problem

(Posted Sept. 22, 2026, on LinkedIn) The world of prescription drug advertising is indisputably a world unto itself, but both the Department of Health and Human Services and FDA seem determined to reel in such advertising. FDA released a batch of warning letters to manufacturers last year on that subject,

IVUS, OCT Still Struggling for Traction in Cath Labs

(Posted Sept. 3, 2026, on LinkedIn) Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are anything but the latest thing in the modern cath lab, but cardiologists seem less than unified in their views of their utility. At one end of the debate is a recommendation for extensive use of

A Difference That Makes No Difference: UT v. Boston Scientific

(Posted Aug. 4, 2026, on LinkedIn) Today we review an interesting case arising from the Court of Appeals for the Federal Circuit. In this lawsuit, Boston Scientific prevailed over the Board of Regents of the University of Texas (UT) in an outcome that completely and exhaustively reversed a jury verdict.

CMS Eyes End of Alternative NTAPs in Inpatient Draft And Looks Forward to RAPID

(Posted May 6, 2026, on LinkedIn) CMS has proposed to terminate the alternative pathway for the new technology add-on payment (NTAP) mechanism, and Judy Rosenbloom and Jo Ellen Slurzberg of JR Associates Inc. told me that the sheer volume of breakthrough devices might be a source of congestion for

Observations about day two of the MDMA annual meeting

(Posted May 1, 2026, on LinkedIn) The second day of the 2026 MDMA meeting featured a talk by CMS administrator Mehmet Oz. There was some expectation that Oz would have a lot to say about the Regulatory Alignment for Predictable and Immediate Device (RAPID) proposal, but he didn’t say

Notes from the MDMA Annual Meeting in D.C.

(Posted April 30, 2026, on LinkedIn) I'm here at the annual meeting of the Medical Device Manufacturers Association in Washington, D.C., and here are a few notes about remarks by FDA commissioner Marty Makary. Makary discussed a number of subjects related to pharma and biotech along with

New FDA Programs Full of Promise, but Pitfalls Loom

(Published April 13, 2026, on LinkedIn) FDA has rolled out several new programs recently that promise to cut red tape for medical product applications to improve patient access. Still, Nate Downing of Gardner Law told me in an interview that while these programs have much to offer, manufacturers shouldn’t

How Time Flies When You’re (Not) Having Fun

(Posted on LinkedIn March 23, 2026) I would ask if it’s really already the fourth week of March, but I’m still agog over the fact that it really is already 2026. With that in mind, let’s revisit some of the goings-on in the third week of

Medicare

Patients caught in squabbles over infectious disease testing

(Published March 11, 2026, on LinkedIn) Clinical diagnostic testing has always been one of the most complex areas of healthcare, but while there are instances of fraud, even conscientious lab operators are stuck with a coding system that is both awkward and prone to abuse, often leaving patients without access

Patents

Federal Circuit upholds PTO’s authority to reject IPRs

(Published on LinkedIn Feb. 16, 2026) The U.S. Court of Appeals for the Federal Circuit declared in a Feb. 13 decision that the Patent and Trademark Office’s discretion to deny institution is not circumscribed by the Administrative Procedures Act, an outcome that sends a clear signal to stakeholders