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BioWorld - Friday, December 19, 2025
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Oct. 6, 2020

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Health, medical icons

Smartphone-connected pacemaker devices, experimental gene therapy among top 10 innovations at annual event

As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation. Read More
Illustration of business bar chart being toppled by coronavirus

Pandemic drives lasting changes in med-tech industry

COVID-19 has prompted dramatic rethinking of supply chains, health care delivery, regulations, and collaboration that are likely to permanently restructure the med-tech industry, according to industry leaders speaking at a panel during the Advanced Medical Technology Association’s (Advamed) Virtual Medtech Conference on Oct. 6. In addition, the significant increase in debt and strong fundamentals position the industry for a burst of M&A activity. Read More
Jeff Shuren

FDA’s Shuren pounds on inadequacy of statute in CDRH town hall

The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology. Read More
Product image

Astrazeneca strikes deal with Impedimed for Sozo platform in heart failure, kidney disease trial

PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease. Read More
Costa-Rica-flag

Costa Rica clears the way for untested ventilators developed by its universities

CAJICA, Colombia –The government of Costa Rica issued guidelines recently that will allow the country’s social security system to source the country's hospitals with ventilators produced by the faculties of the universities of the Latin American country, during the COVID-19 outbreak. Read More
Drug-vials

FDA delivers on promise of guidance for vaccine EUAs

Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine. Read More

Stakeholders sound off on Medicare doc fee, outpatient drafts

The latest global regulatory news, changes and updates affecting medical devices and technologies. Read More

Appointments and advancements for Oct. 6, 2020

New hires and promotions in the med-tech industry, including: Cmr Surgical, Inspiremd, Karius. Read More

Financings for Oct. 6, 2020

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

In the clinic for Oct. 6, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Beckman Coulter, Daxor, Guardant Health. Read More

Other news to note for Oct. 6, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, 1Health.io, Abbott Laboratories, Biologica Technologies, Clear, Diagnostic Robotics, Emanate Wireless, Genentech, Imbio, Ion Beam Applications, Iprocedures, Medshape, Mesuron, Mgroup, Neupath Health, Opum US, Pharmajet, Pivot Design Group, Qiagen, Quanterix, Quest Diagnostics, Readcoor, Sanara Medtech, Shin-Ho Instruments, Tyber Medical, Vizient, Xtant Medical. Read More

Regulatory actions for Oct. 6, 2020

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosense Webster, Setpoint Medical. Read More

BioWorld MedTech’s Oncology Extra for Oct. 6, 2020

Keeping you up to date on recent developments in oncology, including: New data cast doubt on post-resection radiotherapy for NSCLC; Carcinogens need not be mutagens; Myelin regulatory factor assists pancreatic cancer cells; Deepmedic provides glioblastoma segmentation with sparsified data. Read More

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