Medical Devices News and Research

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FDA clears new robotically-assisted surgical device for transvaginal hysterectomy

The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients.

1 Mar 2021

FDA to finalize the issuance of emergency use authorization for vaccine distribution

Following today's positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.

27 Feb 2021

FDA approves Nulibry to reduce risk of death caused by rare genetic, metabolic disorder

Today, the U.S. Food and Drug Administration approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to Molybdenum Cofactor Deficiency Type A, a rare, genetic, metabolic disorder that typically presents in the first few days of life, causing intractable seizures, brain injury and death.

27 Feb 2021

Researchers develop an electroceutical for preterm labor detection and treatment

Preterm labor comprises 12.7% of all pregnancies. Although the overall rate of pregnancy is decreasing, the occurrence of premature birth due to preterm labor in south korea has been increasing over the past 7 years.

26 Feb 2021

COVID-19 Antigen Self-Test from Siemens Healthineers receives special approval in Germany for self-use by laypeople

Siemens Healthineers announced today that the CLINITEST Rapid COVID-19 Antigen Self-Test has received limited special approval from the Federal Office for Drugs and Medical Devices.

From Siemens Healthineers 25 Feb 2021

Forest Devices publishes positive results from study of its AlphaStroke technology

Medical technology pioneer Forest Devices, Inc. today announced the publication of positive results from the EDGAR study of its AlphaStroke™ technology in identifying patients with large vessel occlusive strokes in emergency departments in the American Heart Association Journal, STROKE.

25 Feb 2021

Hydrogel injection could help repair damage to the heart muscle after heart attack

Researchers at CÚRAM, the SFI Research Centre for Medical Devices based at NUI Galway, and BIOFORGE Lab, at the University of Valladolid in Spain, have developed an injectable hydrogel that could help repair and prevent further damage to the heart muscle after a heart attack event.

19 Feb 2021

iCOquit®: The innovation aiding remote Stop Smoking Services during COVID-19

The new Bluetooth® CO monitor from Bedfont® Scientific Ltd. has helped Stop Smoking Clinics to continue giving essential advice to its patients through remote CO monitoring.

From Bedfont® Scientific Ltd 17 Feb 2021

Akkure Genomics raises €1.2 million to accelerate roll-out of its next-generation clinical trials platform

Akkure Genomics, an Irish digital health scaleup which is developing a disruptive MedTech platform for the global clinical trials industry, has raised just over €1.2 million in a crowdfunding campaign from 318 investors.

13 Feb 2021

FDA issues EUA for bamlanivimab and etesevimab for COVID-19 treatment

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.

10 Feb 2021

New program could advance translation of research, improve lives of older adults

In this digital age, where the internet accelerates technological development, there has been a surge of scientific innovation designed to improve the quality of life for patients in need.

9 Feb 2021

FDA schedules meeting to discuss EUA request for Janssen’s COVID-19 vaccine

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.

5 Feb 2021

Study: Remote supervision could expand access to neurointerventional technologies

Physicians training on novel technologies and surgical devices by other already experienced physicians, known as proctoring, is a fundamental aspect of medicine.

4 Feb 2021

European biotech companies rely on AI to deliver COVID-19 vaccine

A high-standard health system, rich health data and a strong research and innovation ecosystem are Europe's key assets that can help transform its health sector and make the EU a global leader in health-related artificial intelligence applications.

4 Feb 2021

Novel 3D-printed esophageal stents could revolutionize the delivery of cancer treatment

World-first 3D printed esophageal stents developed by the University of South Australia could revolutionize the delivery of chemotherapy drugs to provide more accurate, effective and personalized treatment for patients with esophageal cancer.

3 Feb 2021

Albumin: The Natural Choice for Diagnostic Tests

The availability of established diagnostic kits has enabled researchers to plug-and-play in the design of COVID-19 diagnostics. Such technologies took decades to optimize, but they are now playing an important role in identifying and managing the spread of COVID-19. Recombumin® provides an enhanced solution as part of this toolbox for dealing with this disease

From Albumedix Ltd. 2 Feb 2021

Albumedix submits Drug Master Files for its products in Japan

Albumedix Ltd. (‘Albumedix’), the world leader in recombinant human albumin (rHA), announced today the submission of Drug Master Files (DMFs) to the Pharmaceutical and Medical Device Agency (PMDA) in Japan.

From Albumedix Ltd. 2 Feb 2021

Albumedix enters into collaboration agreement with Cell and Gene Therapy Catapult

Albumedix Ltd. (‘Albumedix’), an enabler of advanced therapies and the world leader in recombinant human albumin (rAlb), announced today that they have entered into a collaboration agreement with Cell and Gene Therapy Catapult (CGT Catapult) to investigate the use of Albumedix´ proprietary albumin-based solutions for advanced therapy applications, including viral vectors manufacturing.

From Albumedix Ltd. 2 Feb 2021

Sepha Launches Small Batch Contract Packaging Service

Sepha, the Northern Ireland based specialist in pharmaceutical packaging and machinery, has launched a contract packaging service to meet rising demand for small batch production.

1 Feb 2021

Study may lead to novel synthetic drugs to combat bacterial infections

Researchers at the Technion – Israel Institute of Technology and EMBL Hamburg have discovered remarkable molecular properties of an antimicrobial peptide from the skin of the Australian toadlet. The discovery could inspire the development of novel synthetic drugs to combat bacterial infections.

15 Jan 2021

Medical Devices News and Research

FDA clears new robotically-assisted surgical device for transvaginal hysterectomy

FDA to finalize the issuance of emergency use authorization for vaccine distribution

FDA approves Nulibry to reduce risk of death caused by rare genetic, metabolic disorder

Researchers develop an electroceutical for preterm labor detection and treatment

COVID-19 Antigen Self-Test from Siemens Healthineers receives special approval in Germany for self-use by laypeople

Forest Devices publishes positive results from study of its AlphaStroke technology

Hydrogel injection could help repair damage to the heart muscle after heart attack

iCOquit®: The innovation aiding remote Stop Smoking Services during COVID-19

Akkure Genomics raises €1.2 million to accelerate roll-out of its next-generation clinical trials platform

FDA issues EUA for bamlanivimab and etesevimab for COVID-19 treatment

New program could advance translation of research, improve lives of older adults

FDA schedules meeting to discuss EUA request for Janssen’s COVID-19 vaccine

Study: Remote supervision could expand access to neurointerventional technologies

European biotech companies rely on AI to deliver COVID-19 vaccine

Novel 3D-printed esophageal stents could revolutionize the delivery of cancer treatment

Albumin: The Natural Choice for Diagnostic Tests

Albumedix submits Drug Master Files for its products in Japan

Albumedix enters into collaboration agreement with Cell and Gene Therapy Catapult

Sepha Launches Small Batch Contract Packaging Service

Study may lead to novel synthetic drugs to combat bacterial infections

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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