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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 20, 2021

View Archived Issues
Portico, Flexnav devices

Abbott gains foothold in TAVR market with FDA approval of Portico device

Roughly a decade has passed since the FDA first approved a transcatheter aortic valve replacement (TAVR) device, but the U.S. market has proven difficult to access for more than a small number of manufacturers. Abbott Laboratories, of Abbott Park, Ill., is now a player in the market with the FDA’s approval of the Portico device, a product that was first implanted in a human subject in 2011, a clear demonstration of the difficulty of moving these devices from research and development to the market. Read More
Coronavirus and antibodies

FDA clears Memed’s point-of-care infectious disease test

The U.S. FDA has cleared Memed Diagnostics Ltd.'s blood test for distinguishing between bacterial and viral infections. The diagnostic test has been tipped as an essential step in the fight against antimicrobial resistance. While most infectious disease tests look for the pathogen, Memed BV is an advanced host immune response test that measures the levels of immune system proteins and applies proprietary algorithms to generate an immune signature. Read More
Proteomics platform in lab

Oncohost platform predicts response to lung cancer therapy

Prophet, Oncohost Ltd.’s artificial intelligence-driven proteomics profiling platform, predicted response to immune checkpoint inhibitor (ICI) therapy in non-small-cell lung carcinoma (NSCLC) patients in a study presented at the European Society for Medical Oncology Virtual Congress 2021. While ICI can generate a significant positive response in some patients with advanced NSCLC, in others the therapy promotes tumor growth, making identification of likely responders prior to treatment critical. Read More
Product recall concept image

FDA notes two fatalities in connection with Medtronic subsidiary’s Pipeline devices

The U.S.FDA said the recall of two models of the Pipeline Flex embolization devices is due to a risk that the delivery system’s wire and tubes will fracture during placement of the stent. The agency said the recall is associated with 59 reports of malfunction, 10 serious injuries and two fatalities, making this a class I event. Read More
surgery.png

Cardiologist hit with nearly $7M settlement over allegations of unnecessary ablations, stenting

Physicians occasionally go over the line where Medicare services are concerned, but the U.S. Department of Justice announced Sept. 15 that a cardiologist in Orlando, Fla., went farther than the ordinary illicit billing. Read More
Children in classroom wearing masks

Pfizer/Biontech announce first data backing COVID-19 shot in children ages 5-11

Pfizer Inc. and Biontech SE have announced new data that could pave the way for childhood COVID-19 vaccine programs, with findings of a trial showing their shot is safe and effective in children of 5 to 12 years of age. Read More
Fingerprints in shape of lungs with magnifying glass and DNA

As targeted options expand, making the best match, and the most matches

Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given. Read More

Appointments and advancements for Sept. 20, 2021

New hires and promotions in the med-tech industry, including: Biolife Solutions, Ehealth, Nextgen Healthcare, Oneskin, Xenocor. Read More

Financings for Sept. 20, 2021

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

In the clinic for Sept. 20, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angle, Boston Scientific, Mir Scientific, Xilis. Read More

Other news to note for Sept. 20, 2021

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aikido, Attillaps, Bluegrass Vascular, Glaukos, Grail, Kerna, Masvida, Medifocus, N2 Biomedical, Orasure Technologies, Precision Coating, Smartlabs. Read More

Regulatory actions for Sept. 20, 2021

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Cosara Diagnostics. Read More

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