U.S. physicians who provide radiation services for cancer patients have a long-running feud with the Centers for Medicare & Medicaid Services over a series of payment rate cuts for their services, but these medical societies are now teaming up to address the issue. These medical societies are making the case that payment reform is not only critical for the future of radiation oncology but are also optimistic that congressional interest in the dilemma has quickened sufficiently to suggest that a congressional response may be on tap in 2024.
The U.S. Centers for Medicare & Medicaid Services (CMS) issued the final rule for data interoperability and prior authorization (PA) for health plans, which is designed in part to improve the PA process used by payers.
The U.S. FDA has announced a class I recall of Iveninx large-volume infusion pumps made by Fresenius Kabi USA of Lake Zurich, Ill., due to a mechanical issue with fluid valve pins that could cause the pumps to shut down. Fresenius is rolling out a remediation plan for more than 900 pumps affected by the recall, which to date has been associated with no reports of injury or death.
The history of med-tech patent litigation is replete with long-running conflicts that test the willpower of the participants, which increasingly seems to be the case in a series of lawsuits between Masimo Corp. and Apple Inc.
The U.S. Patent and Trademark Office (USPTO) published new enablement guidelines Jan. 10 to provide more consistency across technologies to ensure patent applications truly enable the breadth of their claims in keeping with the Supreme Court’s unanimous decision last year in Amgen Inc. v. Sanofi SA.
In what represents the first patenting from Immersive Reality Group LLC, the company’s co-founders describe their Intellighealth system for detecting the early onset of respiratory diseases using artificial intelligence and wearable remote health monitoring technologies.
The ongoing controversy over the use of ethylene oxide (EtO) as a medical device sterilant has yielded a certification by the U.S. FDA for hydrogen peroxide as an alternative category A sterilant. The news is a welcome bit of relief for industry and for patients as the Environmental Protection Agency still seems bent on imposing what some in industry see as draconian controls on EtO, which is still employed to sterilize half of all medical devices used in the U.S. each year.
Medtronic plc received the greenlight from the U.S. FDA for its latest deep brain stimulation system, the Percept RC. The rechargeable neurostimulator includes the company’s sensing technology which captures data from brain signals and allows for more personalized therapy.
The U.S. Patent and Trademark Office (USPTO) published new enablement guidelines Jan. 10 to provide more consistency across technologies to ensure patent applications truly enable the breadth of their claims in keeping with the Supreme Court’s unanimous decision last year in Amgen Inc. v. Sanofi SA.
Ultromics Ltd. joined forces with Pfizer Inc. to expedite U.S. FDA clearance of its artificial intelligence (AI)-enhanced platform to aid early diagnosis of cardiac amyloidosis, also known as stiff heart syndrome. The company received FDA breakthrough device designation last year for Echogo Amyloidosis, which uses deep AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, a serious condition often missed during standard heart assessments.
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