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BioWorld - Monday, February 23, 2026
Home » Topics » Regulatory, Medical technology

Regulatory, Medical technology
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Website of The Federal Trade Commission

US FTC snares $14.6M grant for technology upgrades

July 30, 2025
By Mark McCarty
The U.S. Federal Trade Commission announced a $14.6 million grant it received for an upgrade of its IT infrastructure. The same grant mechanism is leveraged by the Department of Justice, which is a clear sign that U.S. enforcement will be more vigorously enabled by sophisticated analytics going forward.
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Art concept for monoclonal antibodies
Immuno-oncology

Radiopharm Theranostics cleared to advance RV-01 into clinic

July 30, 2025
No Comments
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
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Boston Scientific - Watchman FLX

Cardiologists blast Medicare LAA closure draft

July 29, 2025
By Mark McCarty
The ink is barely dry on the draft Medicare physician fee schedule for 2026, but three cardiology societies blasted the draft for cutting rates for left atrial appendage closure procedures – a move they said needlessly endangers patients.
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Intracept RF Generator and Intracept RF Probe

Boston Sci offers new neuromod treatments to European patients

July 29, 2025
By Shani Alexander
Boston Scientific Corp. received CE mark certification under the Medical Device Regulation for its Intracept intraosseous nerve ablation system, bringing another treatment option to patients with chronic pain.
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Illustration of head with circuit board brain

NIH unveils MRI system capable of visualizing the connectome

July 29, 2025
By Mark McCarty
Understanding neurological disease requires several things, including a clear view of the connectome, and the U.S. National Institutes of Health may have a solution in the form of a new MRI system that allows the user to examine neural connections at the mesoscopic and microscopic scales.
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CMS logo and website

CMS revisits coverage criteria for Parkinson’s, essential tremor

July 28, 2025
By Mark McCarty
An advisory committee for the U.S. Centers for Medicare & Medicaid Services endorsed a series of patient- and clinician-reported outcomes that might not be reflected in the evidentiary bases for currently available technologies. This development suggests some manufacturers will have to conduct new studies of their devices in order to sustain Medicare coverage.
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FDA icons and doctor

Baxter clarifies Novum IQ update, but root cause unclear

July 28, 2025
By Mark McCarty
The U.S. FDA posted an update on the early alert for the Novum IQ infusion pump by Baxter International Inc., which includes a suggestion that the administration set be moved half an inch farther down the line before doubling the bolus infusion rate.
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Exterior of NIH Vaccine Research Center

Republican senators flag NIH funding delays

July 28, 2025
By Mari Serebrov
No Comments
While U.S. government cost-cutting seems to be the Trump administration’s priority that consumes all others, some Republican senators are pushing back – at least when it comes to the NIH. Fourteen senators wrote to Russell Vought, head of the White House Office of Management and Budget, to voice their concerns about the administration’s slow disbursement rate of the NIH’s fiscal 2025 funds.
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3D map of China

Cryofocus’ asthma device wins FDA breakthrough label

July 25, 2025
By Marian (YoonJee) Chu
Cryofocus Medtech (Shanghai) Co. Ltd. received U.S. FDA breakthrough device designation on July 24 for its cryoablation system for asthma. The Chinese med-tech’s stock (HKEX:6922) rose near 20% over two consecutive days on the Hong Kong Stock Exchange with the news, increasing from HK$5.00 ($.64) July 23 to HK$5.98 nearing the close of trading on July 25.
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Roche building

Roche receives CE Mark for Alzheimer’s rule out test

July 24, 2025
By Shani Alexander
Roche Holding AG received CE mark for its Elecsys pTau181 test to help rule out Alzheimer’s disease. The minimally invasive blood test, developed in collaboration with Eli Lilly and Co., measures phosphorylated Tau 181 protein, a biomarker indicative of amyloid pathology, a hallmark of Alzheimer’s.
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