The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor.

The U.S. FDA approved a new feature for detecting obstructive sleep apnea (OSA) on the Samsung Galaxy watch and smartphone, Samsung Electronics Co. Ltd. said on Feb. 10.

Masimo Corp. received a pinch of good news with the U.S. FDA’s clearance of its medical-grade fingertip pulse oximeter, Mightysat Medical, for over-the-counter (OTC) sale. The device uses the same technology as Masimo’s Set pulse oximetry used in hospitals and clinics.

Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.

The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago and would seem to suggest that the agency will more routinely require the use of DMCs than was common practice in the past.

The Feb. 8 U.S. drug pricing hearing before the Senate Health, Education, Labor and Pensions Committee started out as a spectacle in which Chair Bernie Sanders (I-Vt.) rehashed his usual talking points as he lectured the CEOs of Bristol Myers Squibb Co., Johnson & Johnson and Merck & Co. Inc. about how their companies charge so much more for their drugs in the U.S. than in other countries. But despite the show-trial aspects of the hearing, or what Ranking Member Bill Cassidy (R-La.) called Sanders’ ongoing “CEO-whack-a-mole” agenda, some facts came through that could lead to pricing reforms if Congress has the bipartisan will to do so.

Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution.

Shadowed by prescription drug shortages at their highest level since 2014, the FDA issued a slightly revised version Feb. 6 of a draft guidance it released a year ago to give it more visibility into the U.S. drug supply chain.

The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.