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BioWorld - Saturday, April 11, 2026
Home » Topics » Medical technology

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FDA hits Q’Apel Medical with warning for design changes to Hippo

March 19, 2025
By Mark McCarty
The U.S. FDA warning letter to Q’Apel Medical Inc., of Fremont, Calif., lists several deviations from the regulation, but the agency said the company’s Hippo device for is misbranded because Q’Apel had failed to file with the agency for changes to the device design.
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Nandoun Abeysekera, founder and CEO, Avasa
Newco news

New Zealand’s Avasa develops world-first arterial coupler

March 19, 2025
By Tamra Sami
New Zealand med-tech startup Avasa Ltd. has developed an arterial coupler that could save surgeons 30 minutes in the operating room to better connect arteries.
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Control-IQ+ by Tandem Diabetes Care Inc.

Tandem’s Control-IQ+ looks like a smart move for insulin-using T2D

March 19, 2025
By Annette Boyle
Tandem Diabetes Care Inc.’s Control-IQ+ automated insulin delivery system improved multiple measures of glycemic control in individuals with type 2 diabetes who use insulin, a study presented March 19 at the 18th International Conference on Advanced Technologies & Treatments for Diabetes and published in The New England Journal of Medicine demonstrated.
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Regulatory actions for March 19, 2025

March 19, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomeriux, Guerbet, Magstim, Moon Surgical, Nvidia, Orthofix, Welcony.
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Other news to note for March 19, 2025

March 19, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: GE Healthcare, Nvidia, Patricia Industries.
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In the clinic for March 19, 2025

March 19, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Icecure Medical, Integrum, Ondine Biomedical, Sonovascular.
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Financings for March 19, 2025

March 19, 2025
Med-tech firms raising money in public or private financings, including: Dassault Systèmes, Click Therapeutics, Iridex, Medidata, Sequana.
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WHO headquarters, Geneva

WHO looking to fill funding gap left by the US

March 18, 2025
By Mari Serebrov
The U.S. foreign aid cuts and freezes that are taking place under President Donald Trump are putting at risk the global public health gains that have been made against diseases such as malaria, HIV and tuberculosis over the past two decades, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said at a March 17 media briefing, as he called on other countries to step up and fill the gap.
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Prescription pad

Legislation would authorize AI to write prescriptions

March 18, 2025
By Mark McCarty
The unrelenting pressure on medical practice in the U.S. has sparked some innovations, but a legislative innovation is now in the works that would fundamentally shift how at least some drugs are prescribed. The Healthy Technology Act of 2025 (H.R. 238) would allow AI and machine learning algorithms to write prescriptions for pharmaceuticals, although the lack of co-sponsors for H.R. 238 suggests that this bill is not ready for prime time just yet.
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Architectural pillars

Qui tam provisions of US False Claims Act under increasing pressure

March 18, 2025
By Mark McCarty
U.S. law allows whistleblowers to file suit for violations the False Claims Act, but the legality of these qui tam relators under the Appointments Clause is under intense scrutiny thanks to a case heard in Florida district court.
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