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BioWorld - Friday, December 26, 2025
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 21, 2022

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Evolut FX image

Encouraging outcomes for Medtronic’s Evolut as research shows challenges with SAVR after TAVR

Transcatheter aortic valve replacement (TAVR) continues to grow, so it is little surprise that the 2022 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting featured multiple presentations about TAVR-related devices and outcomes. The American College of Cardiology/American Heart Association’s latest guidelines recommends TAVR for patients over age 80 and surgery for those under age 65. Those in the middle can go either way, depending on comorbidities and patient preferences. Read More

OIG says FDA’s stumbles in COVID testing EUAs highlights need for national strategy

The U.S. response to the emergence of the COVID-19 pandemic may by now be the stuff of public health policy lore, with both the FDA and the CDC contributing to the chaos in the first months of the pandemic. The Office of Inspector General has issued an analysis of the situation, and while OIG revisited some of the known miscues, the report also made the case that a national strategy for pandemic response will be needed if federal government efforts in the future are to be less a hazard to the lives of American citizens than those seen in the first half of 2020. Read More
tricuspid regurgitation

Tricares closes $47M for development of Topaz valve for tricuspid regurgitation

Tricares SAS raised $47 million in a first closing of its series C financing to fund further development of Topaz, its minimally invasive treatment for tricuspid regurgitation. The completion of the series C financing round is expected later in 2022. Read More

Biden’s remarks regarding pandemic prompts Congress to revisit COVID funding

President Joseph Biden’s recent statement that the COVID-19 pandemic is over may or may not reflect popular fatigue with the associated public health emergency (PHE), but the statement struck a different tone in some quarters on Capitol Hill. Sen. Richard Burr (R-N.C.) was one of several who argued that the need for the PHE had thus necessarily run its course, with Burr specifically calling into question the need for additional funding for COVID-related federal health efforts. Read More
Cardiovascular illustration

Late-breaking trials at TCT provide good news for major med-tech device companies

The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with updates from Abbott Laboratories, Abiomed Inc., Boston Scientific Corp., Edwards Lifesciences Corp., Inari Medical Inc., Medtronic plc and Recor Medical Inc. Read More

Appointments and advancements for Sept. 21, 2022

New hires and promotions in the med-tech industry, including: Cerehealth, Clearpoint Neuro, Cumulus Neuroscience. Read More

Financings for Sept. 21, 2022

Med-tech firms raising money in public or private financings, including: Know Labs, Medtronic, Microtransponder. Read More

In the clinic for Sept. 21, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Exscientia, Photocure, Pulnovo Medical. Read More

Other news to note for Sept. 21, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biomérieux, Brightinsight, Novocure, Ra Medical Systems, Spineway. Read More

Regulatory actions for Sept. 21, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ivory Graft, Medtronic. Read More

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