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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

July 23, 2021

View Archived Issues
Transaeris system

Synapse’s diaphragm pacing system nabs FDA breakthrough status

Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse. Read More
respiratory-lung-COVID-19-coronavirus.png

Owlstone bid to use masks for COVID-19 detection meets a dead end, may prove useful for other conditions

LONDON – An attempt to develop an alternative sampling method to replace unpleasant nasopharyngeal swabbing in COVID-19 diagnosis has failed, with researchers at Owlstone Medical Ltd. finding the number of viral particles that can be collected from the breath of hospitalized patients is below the limit of detection. Owlstone is a specialist in collecting and analyzing breath samples to look for volatile organic compounds that are biomarkers of disease, such as lung cancer and asthma. Read More
Regulatory-US-FDA-HQ.png

Inconsistencies between FDA’s QSR and ISO 13485 yield a complicated navigational task

The FDA is working toward a rewrite of its Quality Systems Regulation (QSR) and ISO 13485, the internationally recognized quality management standard, but that project has yet to produce a draft rule despite several years of effort. The FDA’s Vidya Gopal highlighted the differences between the two approaches to questions such as management responsibility and staff resources, just two of many differences that will prove difficult to reconcile in any regulatory harmonization effort. Read More
Flag of Australia, sky background

TGA proposes refinements to regulations for devices introduced via body orifices or skin

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is proposing refinements to the regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin. Read More
Philips cardiac MRI scanner

Philips working on MRI protocol that can analyze the heart in less than a minute

PARIS – Royal Philips NV is working with the Spanish National Center for Cardiovascular Research (CNIC) on an ultrafast cardiac magnetic resonance imaging (MRI) protocol that could reduce scanning times to just a few minutes. Read More

Input wanted on expanding research access to AI infrastructure

The U.S. Office of Science and Technology Policy and the National Science Foundation are issuing a request for information to help the National Artificial Intelligence Research Resource Task Force in developing an implementation roadmap. Read More

Appointments and advancements for July 23, 2021

New hires and promotions in the med-tech industry, including: Fresenius. Read More

Financings for July 23, 2021

Med-tech firms raising money in public or private financings, including: Cytek Biosciences, Sophia Genetics. Read More

In the clinic for July 23, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Edwards, Foodmarble, Inspiremd. Read More

Med-tech gainers and losers for July 19-23, 2021

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

Other news to note for July 23, 2021

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Meridian Biosciences, Otsuka. Read More

BioWorld MedTech Patent Highlights: Week 28

BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette. Read More

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