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BioWorld - Saturday, January 10, 2026
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Apple Watch pulseox

Analysts see tide turning toward Masimo in Apple patent war

Nov. 18, 2025
By Mark McCarty
A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634 million which is seen in some quarters as an indicator that Masimo has the momentum against Apple.
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Medtronic - Symplicty Spyral HTN

Pulsed field ablation lifts Medtronic Q2 results

Nov. 18, 2025
By Annette Boyle
Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation system tripled the company’s sales in the hot PFA segment and pushed the cardiac ablation solutions unit to 71% growth, a nice uptick from the nearly 50% seen in its Q1.
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Judge's gavel with US flag

Aesculap clears its legal troubles with $38.5M OIG settlement

Nov. 18, 2025
By Mark McCarty
Aesculap Implant Systems LLC has seen its share of bad news recently, but the company seems to have cleared the legal deck with an agreement to pay $38.5 million per a Nov. 17 announcement by the U.S. attorney’s office for the district of Eastern Pennsylvania.
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Dollar sign dropper and test tube

Scrutiny of NIH funding cuts, potential retaliation continues

Nov. 17, 2025
By Mari Serebrov
No Comments
Over a span of five-and-a-half months this year, 3.5% of the more than 11,000 clinical trials funded by the U.S. NIH had their grants terminated, according to an article published in the Nov. 17 JAMA Internal Medicine. That’s 383 trials that lost funding.
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CMS logo and website

WISeR model said to create incentives to deny claims

Nov. 17, 2025
By Mark McCarty
The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services.
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Collage of businesspeople

Exactech morphs into Advita Ortho after passing on a 10-year CIA

Nov. 17, 2025
By Mark McCarty
Exactech Inc., of Gainesville, Fla., decided it will not subject itself to a 10-year corporate integrity agreement with the Office of Inspector General, an understandable move given that the company no longer intends to do business in the U.S. under its old brand.
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Withings Beamo multi-sensor device

FDA clears Withings Beamo, ‘thermometer of the future’

Nov. 14, 2025
By Shani Alexander
Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an electrocardiogram, a stethoscope and a thermometer into a hand-held device to allow users to check their body temperature, cardiac and pulmonary health in less than a minute.
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U.S. EPA building

EPA eases up on PFAS reporting requirements

Nov. 14, 2025
By Mark McCarty
The U.S. Environmental Protection Agency has moved to relax reporting requirements for perfluoroalkyl and polyfluoroalkyl substances used in a variety of applications, including medical devices.
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Komzifti packaging

FDA clears Kura/Kyowa’s Komzifti in r/r NPM1 mutant AML

Nov. 13, 2025
By Tamra Sami
The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.
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Deal handshake with coin, chart background

ABL Bio’s Grabody lands second $2.6B deal, this time with Lilly

Nov. 13, 2025
By Marian (YoonJee) Chu
No Comments
ABL Bio Inc. inked a license and research agreement with Eli Lilly and Co. worth up to $2.6 billion to develop multiple therapeutics using the Grabody-B platform. Under the terms announced Nov. 12, ABL will receive a $40 million up-front payment and up to $2.56 billion in development, regulatory and commercialization milestones, plus tiered royalties on net sales.
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