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BioWorld - Tuesday, December 23, 2025
Breaking News: BioWorld 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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Europe map, white on blue

Stakeholders already sounding off on EC review of device regs

Sep. 9, 2025
By Mark McCarty
The European Commission (EC) posted a call for evidence regarding its intent to “simplify EU rules” for medical technology with a comment period that began Sept. 8, 2025. Stakeholders almost immediately flooded the docket with recommendations.
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Chanelle Case Borden pipetting DNA samples into a tube for polymerase chain reaction.

OIG calls for compulsory emergency plans for independent labs

Sep. 9, 2025
By Mark McCarty
The U.S. Office of Inspector General said in a recent report that independent testing labs should be required to develop emergency preparedness plans for public health emergencies, a move that would affect industry giants such as Laboratory Corporation of America and Quest Diagnostics Inc.
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"IPOs" over dried and cracked earth
Med-tech financings August 2025

Med-tech financings hold steady through August, IPOs rebound

Sep. 9, 2025
By Amanda Lanier
Med-tech financings reached $20.21 billion in the first eight months of 2025, on par with the same period last year ($20.26 billion) and showing a strong recovery from the sector’s recent low in 2023 ($13.71 billion). The 2025 total is still well below the record-setting levels of 2020 ($41.83 billion) and 2021 ($38.72 billion).
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Appointments and advancements for Sept. 9, 2025

Sep. 9, 2025
New hires and promotions in the med-tech industry, including: Okomera, Med X Health, Proprio.
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Financings for Sept. 9 2025

Sep. 9, 2025
Med-tech firms raising money in public or private financings, including: Strive Health.
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In the clinic for Sept. 9, 2025

Sep. 9, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alto Neuroscience, Neurolief, Tempus AI, Visura.
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Other news to note for Sept. 9, 2025

Sep. 9, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, Cliseq, Elute, Eyebrain, Metabolon, Neurolight, Neurolens, Newton, Promega, Sapio Sciences, Sight Sciences, SS Innovations, Spartan, Watchmaker Genomics, Ultima Genomics.
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Regulatory actions for Sept. 9, 2025

Sep. 9, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intravent Medical, Neurescue, Varian.
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Heartbeam

Heartbeam's portable device matches standard ECG accuracy

Sep. 8, 2025
By Annette Boyle
Heartbeam Inc.'s algorithms performed as well on a standard 12-lead electrocardiography (ECG) as on its 3D ECG system in the detection of atrial fibrillation, atrial flutter and sinus rhythm, based on a study presented by Joshua Lampert, cardiac electrophysiologist and medical director of machine learning at HRX Live 2025 in Atlanta.
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Gavel and FTC logo

US FTC to revisit noncompete rule after resounding defeat in court

Sep. 8, 2025
By Mark McCarty
The U.S. Federal Trade Commission has opened a docket for comment on noncompete employment contracts, a move which suggests that the agency may revert to evaluating these practices on a case-by-case basis rather than by issuing sweeping rules.
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