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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Nov. 20, 2023

View Archived Issues
Medtronic - Symplicty Spyral HTN

Medtronic rolls out Spyral in US after circuitous journey

The renal denervation hypothesis of hypertension was initially viewed with some skepticism, and Dublin-based Medtronic plc. endured a major setback when clinical trial data failed to make a compelling case for approval for the Symplicity Spyral. However, the company finally landed an FDA approval for the device, opening the gates to a new and significant market opportunity even with competition already on the market. Read More

Surmodics reveals positive data for its Sundance Sirolimus DCB

Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. Results presented at the VEITHsymposium in New York showed that the Sundance Sirolimus DCB demonstrated an excellent safety profile and achieved primary patency of 71.4% at 24 months in the per protocol analysis population. Read More
south-korea-flag-asia.png

MFDS leads global AI-based med device standardization effort

South Korea’s Ministry of Food and Drug Safety (MFDS) will head an international team of regulatory experts from 19 drug agencies worldwide, including the U.S. FDA and China National Institute for Food and Drug Control (NIFDC), to draft an international standard for artificial intelligence (AI)-based software. Read More
Janet Woodcock headshot

FDA's Janet Woodcock plans to retire in 2024

Janet Woodcock, one of the longer-tenured U.S. FDA center directors in the agency’s history, is set to retire sometime in 2024, although the exact date has not been set. Read More
Abtrace

Abtrace system predicts effects of intravenous fluid therapy for shock

In what represents the first Patent Cooperation Treaty filing published in the name of London, U.K.-based Abtrace Ltd., the company’s co-founder and chief executive officer, Umar Naeem Ahmad, collaborates with Xavier Monnet – professor of intensive care at Assistance Publique - Hôpitaux de Paris (APHP) Université Paris-Saclay – on the design of a fluid delivery system for delivering intravenous fluid therapy to a patient. Read More

Med-tech gainers and losers for Nov. 13-17, 2023

The top 10 med-tech stock gainers and losers for the week. Read More

Appointments and advancements for Nov. 20, 2023

New hires and promotions in the med-tech industry, including: Aerin Medical, Fuse Oncology, Neptune Medical. Read More

Financings for Nov. 20, 2023

Med-tech firms raising money in public or private financings, including: Movano. Read More

In the clinic for Nov. 20, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cardio Diagnostics, Lunit, Nevro. Read More

Other news to note for Nov. 20, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, Axcess Surgical, Adaptivendo, Astrazeneca, Canceriq, Exactech, Fortrea, Grail, Greenbrook TMS, Halma, Heartsciences, Icad, Nanostring Technologies, Neurometrix, Parexel, Plasmapp, Quest, Tedan, Universal Dx, Validify, West Coast Surgical. Read More

Regulatory actions for Nov. 20, 2023

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

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