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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Dec. 9, 2020

View Archived Issues
TIVUS system

Sonivie’s TIVUS system secures breakthrough device designation for renal artery denervation

Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc. Read More
Regeltec Hydrafil

Regeltec’s Hydrafil gets breakthrough nod for back pain

A percutaneous hydrogel treatment for chronic low back pain has won a U.S. FDA breakthrough device designation. The status will enhance interactions between Baltimore, Md.-based Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization. Read More
Freespira tablet, sensor and app

Mahana, Freespira ride wave of prescription digital therapeutics

The rising tide of digital therapeutics approved and funded in the U.S. raised the outlook for Mahana Therapeutics Inc. and Freespira Inc. as both companies announced good news. Mahana's prescription digital therapeutic for gastrointestinal conditions, Parallel, received premarket authorization from the U.S. FDA and Freespira, formerly Palo Alto Health Sciences Inc., raised $10 million for its digital therapeutic for panic attacks, panic disorder and post-traumatic stress disorder. Read More

FDA’s Stenzel says staff surge working as evidenced by 65 serology decisions in two weeks

The latest U.S. FDA town hall for diagnostics included the usual technical questions about test validation, but there are some frustrations among test developers regarding turn-around times for emergency use authorizations (EUAs). Nonetheless, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA, said the surge in staff assigned to review EUA filings has worked to some benefit, claiming that the agency has rendered a decision in connection with 65 applications in the two weeks leading up to the Dec. 9 town hall. Read More
AI-tech-head.png

Phar-East 2020 virtual conference looks at tech and transformation

HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and new devices are developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8. Read More
Asia-India-country-flag-map.png

Indian rules pave way for mandatory registration, but patent concerns remain

NEW DELHI – Recent changes to India’s rules on medical devices have evoked mixed reaction among industry and legal experts with concerns over their impact on patenting of innovations tinged with a welcome reception of a new clause for mandatory registration and licensing of medical devices in the country to improve adherence to quality requirements.  Read More

Canada follows the U.K. in approving COVID-19 vaccine

Calling it a “a critical milestone in its fight against COVID-19,” Health Canada authorized the Pfizer Inc./Biontech SE COVID-19 vaccine for people age 16 or older. Read More

Senators sound off on E&M offsets

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP. Read More

Appointments and advancements for Dec. 9, 2020

New hires and promotions in the med-tech industry, including: Bigfoot Biomedical, Opgen, Protech. Read More

Financings for Dec. 9, 2020

Med-tech firms raising money in public or private financings, including: Delcath Systems, Frazier Lifesciences. Read More

In the clinic for Dec. 9, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Becton Dickinson, Cytosorbents, Ellume, Exact Sciences, Follica, Lungpacer Medical, Menarini Silicon Biosystems, Nanostring Technologies, Sengine Precision Medicine, Visualdx. Read More

Other news to note for Dec. 9, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biolab Sciences, Cognitivecare, Colospan, Day Zero Diagnostics, Edap Tms, Htg Molecular Diagnostics, Keraderm, Menicon, Moderna, Mojo Vision, O2 Industries, Patient Power, Remedy Health Media, Roche, Sebia, Sight Diagnostics, Skinopathy, Sorrento Therapeutics, Vitalhub. Read More

Regulatory actions for Dec. 9, 2020

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medical Ingenuities, Mesa Biotech, Regeltec, Sonivie, Volta Medical. Read More

BioWorld MedTech’s Orthopedics Extra for Dec. 9

Keeping you up to date on recent developments in orthopedics, including: Can we make bones heal faster?; Risk of serious complications during knee replacement 73% higher when a tourniquet is used; Exercise may protect bone health after weight loss surgery. Read More

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