The U.S. Patent and Trademark Office opted to allow the 2.0 pilot version of the After Final Consideration Program to expire, bringing to an end a program that ran for longer than a decade.
Depending on how long it lasts, the dockworkers strike that hit all 14 ports on the U.S. East Coast and along the Gulf Oct. 1 could literally unload a world of hurt to patients and the biopharma/med-tech industries, as it will impact both U.S. imports and exports of life-saving drugs and technologies.
A study presented at the American Society for Radiation Oncology on Oct. 1 offers promise for the treatment of high-grade gliomas using Elekta AB’s Unity MR-Linac system.
The controversy over conflicts of interest for Jeff Shuren, formerly the director of the U.S. FDA’s device center, reached Capitol Hill and may lead to an executive branch investigation into the matter.
The Pi-Cardia Ltd. Shortcut — the catheter-based, leaflet modification solution for treating heart valves — received U.S. FDA clearance. The device was granted breakthrough device designation from the regulatory agency and is designed to split bioprosthetic aortic valve leaflets in patients undergoing valve-in-valve transcatheter aortic valve replacement (TAVR) procedures who are at risk of coronary obstruction.
GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in the diagnosis of myocardial ischemia or infarction in patients with known or suspected coronary artery disease.
In some ways, remote patient monitoring (RPM) came of age during the COVID-19 pandemic, but payers still worry about the potential for fraud and abuse. A recent report from the U.S. Office of Inspector General supported concerns about fraud and abuse with RPM, a problem CMS will have to address to constrain unnecessary and potentially illicit spending.
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20.
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20. The spending bill is now awaiting President Joe Biden’s signature.
Neo Medical SA raised $68 million in a series B financing round to accelerate the growth of its spine surgical technologies in the U.S. The infusion of funds allows the company to deploy new products and enhance its artificial intelligence-driven augmented reality platform.
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