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BioWorld - Sunday, May 17, 2026
Home » Topics » Medical technology

Medical technology
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Digital illustration of U.S., coronavirus

FDA’s Stenzel says agency lacks data to extend new pooling policy to antigen tests

April 21, 2021
By Mark McCarty
The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.
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Bioelectronics next to penny

Feinstein team develops long-term vagus nerve stimulation model

April 21, 2021
By Annette Boyle
A team led by researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research, the research division of New York’s Northwell Health, developed a long-term implant model for vagus nerve stimulation (VNS) in mice that enables study of bioelectronics in chronic disease. The research was published in Elife, with a full description of the surgical technique and methods for calibrating the stimulation dose to enable other labs to use the methods to advance bioelectronic medicine.
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Tesseract Ic image

Tesseract Health raises $80M in series B round

April 21, 2021
By Meg Bryant
Tesseract Health Inc. has closed an oversubscribed series B financing, reeling in $80 million with support from Foresite Capital, Glenview Capital and Opaleye. The proceeds will be used to advance the company’s Tesseract Ic eye-imaging diagnostic technology platform, including U.S. and overseas regulatory clearances. This is the first independent financing round for the Guilford, Conn.-based startup, which is developing a platform capable of diagnosing a range of diseases without a single blood draw. The company received prior seed funding as part of the 4Catalyzer med-tech incubator.
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Health professional recording info from patient

Trial site location not always a guarantee of diversity

April 21, 2021
By Mari Serebrov
Location, location, location. Not only is that the mantra for real estate, it often is seen as an answer to diversifying clinical trials. But having a trial site in or near an underserved community is no guarantee of a diverse study population, as health care disparities can be a more pervasive issue than location. That was one of the lessons learned from the development of Celltrans Inc.’s donislecel at the University of Illinois-Chicago.
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Regulatory front for April 21, 2021

April 21, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPSTF sees no reason to recommend screening for AF; Two senators press for UDI data in Medicare claims; Medtronic blood pump console recalled; Federal Circuit affirms PTAB in Cerner/Clinicomp patent dispute.
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Regulatory actions for April 21, 2021

April 21, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biostable Science & Engineering, Cerus Endovascular, Empowered Diagnostics, Enzo Biochem, Johnson & Johnson Vision, Medtronic.
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Other news to note for April 21, 2021

April 21, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affirmxh, Atlas Genomics, Axonlab, Baxter, Cathmedical Cardiovascular, Delcath Systems, Endpoint Clinical, Labcorp, Lifeconnect, Movement Interactive, Opsens, Pixcell Medical, Prevencio, Qiagen, Quick Tube Medical, Red One Medical, Sherlock Biosciences, United PPE, Xphyto.
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In the clinic for April 21, 2021

April 21, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avinger, Humacyte, Prelude, Philips.
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Financings for April 21, 2021

April 21, 2021
Med-tech firms raising money in public or private financings, including: Akoya Biosciences, Baebies.
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Appointments and advancements for April 21, 2021

April 21, 2021
New hires and promotions in the med-tech industry, including: Angiosoma, Assure Holdings, Kalderos, Quanterix, Rayzebio.
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