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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

May 19, 2021

View Archived Issues
Acurate Neo2 device image

Boston Scientific’s Neo2 outshines forerunner in new studies

Boston Scientific Corp. presented late-breaking data at EuroPCR 2021 demonstrating positive procedural performance for its Acurate Neo2 aortic valve system, including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI). The findings are good news, following the older Acurate Neo’s failure to demonstrate noninferiority to Medtronic plc’s Evolut R in the so-called SCOPE II study. Read More
FDA-yellow-dice.png

Consulting attorney: Breakthrough device program not all about speed

The FDA’s breakthrough devices program encodes a number of policy objectives for the agency, but industry might see the program principally as a vector for faster time to market. However, Janice Hogan, partner at Hogan Lovells US LLP, said device makers might want to consider that the greater benefit is reducing regulatory uncertainty, not beating the typical FDA review clock. Read More
Jeff Shuren

Shuren floats optional total product life cycle advisory mechanism

With the next user fee agreement negotiations underway, device makers are not keen on a substantial hike in fee volumes. Nonetheless, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, has proposed a total product life cycle (TPLC) advisory function for the next user fee agreement, something he said would bring more predictability to industry and allow the agency to interact much more routinely with device makers. Read More
Pure-Vu device image

FDA clears Motus Pure-Vu for upper GI endoscopies

Motus GI Holdings Inc. received FDA 510(k) clearance to use its Pure-Vu system in upper gastrointestinal endoscopies, expanding the system’s indications from use only in colonoscopies. Pure-Vu removes blood, blood clots and debris from the GI tract, allowing endoscopists to see sources of bleeding and other issues while leaving the endoscope's working channel available for other uses. Read More
Illustration of person surrounded by risk factor icons

Investment in Ariel genetics platform just the beginning says MCI

TORONTO – An initial investment of $250,000 by MCI Onehealth Technologies Inc. could just be the beginning for Ariel Precision Medicine Inc. and an artificial intelligence-fueled platform that uses genetic and clinical data to identify early symptoms of chronic disease. Read More
Mohamed Khalifa wearing Oxyflex device, holding smartphone showing reading

Tecmoled completes initial testing phase for its ultraflexible organic oximeter for neonate care

PARIS – Tecmoled SAS has just completed the initial testing phase for its wireless oximeter. A prototype has been tested over the past four months on 30 healthy subjects, aged 2 to 70 years, to measure oxygen saturation (SpO₂), heart rate and body temperature. Read More

Appointments and advancements for May 19, 2021

New hires and promotions in the med-tech industry, including: Gravity Diagnostics, Qvella, Rabble Health, Synthace. Read More

Financings for May 19, 2021

Med-tech firms raising money in public or private financings, including: E-merge Capital Partners, Microbix Biosystems. Read More

In the clinic for May 19, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Burning Rock, Heartflow, Pie Medical Imaging, Sera Prognostics, Tela Bio, Treace. Read More

Other news to note for May 19, 2021

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atrium Health, Baebies, Beckman Coulter, Blue Spark Technologies, Bristol Myers Squibb, Cellpath, Eptam Precision Solutions, Glaukos, GT Molecular, Joimax, Kdx Diagnostics, Mendell Machine and Manufacturing, Modern Fertility, Oculogica, Oxford Immunotec, Perkinelmer, Renalytix AI, Ro, Roche, Santen Pharmaceutical, Thermo Fisher Scientific, Trang Thi Medical. Read More

Regulatory actions for May 19, 2021

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Breegi Scientific, Lifesignals, Mindpeak, Tasso. Read More

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