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BioWorld - Tuesday, December 23, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Amended stopgap spending bill includes full 2026 funding for FDA

Nov. 12, 2025
By Mari Serebrov
No Comments
The U.S. House is expected to vote late Nov. 12 on an amended continuing resolution (CR) to end the historic 43-day partial government shutdown. Already passed by the Senate, the CR would fully reopen the government and fund it through Jan. 30. President Donald Trump has said he will sign the CR, which ensures federal employees furloughed during the shutdown will receive back pay and will not be terminated.
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Magstim

Magstim gets FDA nod for chronic pain treatment

Nov. 12, 2025
By Holland Johnson
Magstim Co. Ltd. reported that the U.S. FDA cleared its Magstim Rapid magnetic stimulation system for the treatment of chronic pain. The clearance provides a clinically validated therapy that directly targets neural pathways involved in pain processing to deliver a non-invasive, drug-free treatment for chronic pain.
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Boston Scientific Corp.’s Watchman Flx device
AHA Scientific Sessions

CLOSURE-AF study not the end of the line for LAAC devices

Nov. 11, 2025
By Mark McCarty
At first glance, the results of the CLOSURE-AF study would seem to spell doom for left atrial appendage closure devices for patients at risk of stroke, but there is some noise in the signal, including that the devices used in the study no longer represent the state of the med-tech art.
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Atrial fibrillation illustration
AHA Scientific Sessions

OCEAN study hints at no need for DOACs after afib ablation

Nov. 11, 2025
By Mark McCarty
Patients and their doctors are no fans of long-term use of direct oral anticoagulants (DOACs) after ablation treatment for atrial fibrillation, but three-year data from the OCEAN trial suggests that some patients may not need these DOACs after all, an outcome that qualifies as a crowd-pleaser for all but the makers of these pharmaceutical agents.
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International currency symbols
Med-tech financings October 2025

Med-tech financings reach $26.6B as sector recovery continues

Nov. 11, 2025
By Amanda Lanier
Med-tech financings with disclosed valuations from January through October 2025 totaled $26.58 billion, nearly matching 2022’s $26.83 billion and marking a continued recovery from the sector’s 2023 low of $15.59 billion. The data suggest renewed investor confidence in med-tech, with capital flows shifting back toward public markets after two years of restrained activity.
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Heartflow FFRCT analysis Credit: Heartflow Inc.
AHA Scientific Sessions

FISH&CHIPS serves up appetizing news for Heartflow

Nov. 10, 2025
By Mark McCarty
Shares of Mountain View, Calif.-based Heartflow Inc. have oscillated significantly over the past three months, but the results of a study of the company’s plaque staging system have breathed new life into the company’s shares, boosting them by 7% in Nov. 10 trading.
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Stentrode BCI

Synchron raises $200M to accelerate Stentrode BCI platform

Nov. 10, 2025
By Shani Alexander
Synchron Inc.'s recent $200 million raise for its Stentrode brain-computer interface platform comes at a pivotal time for the technology. Advances in BCI development, ongoing clinical trials and growing market demand are drawing increased investor interest in the technology which has the potential to transform the lives of millions of people. At the same time, government agencies are closely monitoring the field, recognizing the potential while urging caution about the risks involved.
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Symani system

MMI gets IDE for robotic microsurgical study in Alzheimer’s

Nov. 10, 2025
By Holland Johnson
Medical Microinstruments Inc., reported the U.S. FDA approval of an investigational device exemption for a study using its Symani surgical system for treating Alzheimer’s disease, one of its earliest forays into the brain.
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Omniscient brain map

UNESCO adopts ethical standards for neurotechnology

Nov. 7, 2025
By Shani Alexander
UNESCO has adopted the first set of global standards on the ethics of neurotechnology amid the rapid advancement in the development of the technologies and increasing investor interest. These standards, which take effect on Nov. 12, 2025, establish safeguards to ensure that neurotechnology improves the lives of those who need it the most without compromising human rights.
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Pacbio Revio sequencing plate

China lifts Illumina ban, clears Pacbio’s Sequel II CNDx

Nov. 6, 2025
By Marian (YoonJee) Chu
On Nov. 5, the Chinese Ministry of Commerce reported it would lift the export ban on Illumina Inc., which had been in place since March 4. While the ban will be lifted starting Nov. 10, Illumina remains on the unreliable entities list, requiring government approval for instrument purchases.
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