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BioWorld - Sunday, April 26, 2026
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Other news to note for Sept. 11, 2025

Sep. 11, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biodesix, Bioaffinity, Datasea, Dnanexus, Fujifilm, Guardant, Ignite, Lunit, Masimo, Mendaera, Personalis, Royal Philips.
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Regulatory actions for Sept. 11, 2025

Sep. 11, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centinel Spine, Fraiya, Naitive Technologies, Qiagen.
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Pills in the foreground, TV ad for drugs in the background

US FDA cracking down on prescription drug ads

Sep. 11, 2025
By Mari Serebrov
No Comments
It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.
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Cancerguard

Exact Sciences’ Cancerguard MCED test launches for $689

Sep. 10, 2025
By Annette Boyle
Exact Sciences Corp. rolled out its multi-cancer early detection test nationwide to expand screening and identify malignancies when treatment has the greatest chance of being curative. Cancerguard can detect signals for cancers accounting for more than 80% of all cancer diagnoses in the U.S. each year.
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U.S. Capitol building, Washington D.C.

OIG OKs doc ownership in device firm up to 40%

Sep. 10, 2025
By Mark McCarty
Physician ownership of medical device manufacturers can be tricky stuff where the Anti-Kickback Statute is concerned, but the Office of Inspector General recently declared it had no problem with one such arrangement due to the physician’s ratio of ownership of the company.
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Safeheal Colovac SmartVac products suite

Safeheal raises €10M series C extension to advance Colovac device

Sep. 10, 2025
By Shani Alexander
Safeheal SAS secured a further €10 million (US$11.72 million) in a series C extension funding round, adding to the €35 million it raised earlier in the year. The funds will go towards Colovac, its temporary endoluminal bypass device designed as an alternative to stoma for colorectal cancer patients undergoing surgery.
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U.S. Capitol building

GAO acknowledges resource constraints in analysis of Medicare NCDs

Sep. 10, 2025
By Mark McCarty
The U.S. Government Accountability Office said in a recent report that the Medicare national coverage determination process could use a few adjustments, but the report also pointed to significant resource problems associated with the process, a source of drag that only Congress can fix.
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Appointments and advancements for Sept. 10, 2025

Sep. 10, 2025
New hires and promotions in the med-tech industry, including: Conmed, Cumulus Neuroscience, Picard Medical.
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Financings for Sept. 10, 2025

Sep. 10, 2025
Med-tech firms raising money in public or private financings, including: Lucid, PAVmed, Picard.
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Other news to note for Sept. 10, 2025

Sep. 10, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: GE Healthcare, Icometrix, Iridex, Jenavalve.
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