FDA grants IDE to RTI Surgical for breast reconstruction device trial
In 2020, nearly 138,000 breast reconstruction surgeries were conducted in the US for women for breast cancer treatment. Image credits: Shutterstock/STEKLO. The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to RTI Surgical’s allograft dermis, opening the door for a clinical trial to test the device in patients. RTI Surgical’s Cortiva […]
External controls can augment low populations in rare disease trials
The US FDA has published a draft guidance on recommendations to sponsors and investigators on the use of externally controlled clinical trials. Image Credit: Gorodenkoff / Shutterstock. Data collection has been an integral part of conducting clinical trials. With the introduction of new technologies such as machine learning and artificial intelligence (AI), the data collected […]
Augmented & Virtual reality in the classroom
Dr. Marc-Angelo Bisotti, Chairman of the Board and Co-Founder of ApoQlar explored the future tools that will be used in the classroom of healthcare professionals. With a focus on augmented and virtual reality Bisotti explored the risk and cost factors that come with the technology. Source link
FDA clears BrainSpec’s AI-powered MRS platform
BrainSpec’s platform previously received FDA breakthrough device designation for estimating isocitrate dehydrogenase (IDH) status in glioma patients. Image credit: Shutterstock/Viktoriya. The US Food and Drug Administration (FDA) has cleared BrainSpec’s magnetic resonance spectroscopy (MRS) platform, meaning clinicians will now have access to the artificial intelligence (AI)-powered software that measures brain chemistry. BrainSpec’s Core platform uses […]
GE HealthCare debut new AI tech at RSNA 2023
According to the Association of American Medical Colleges (AAMC) there could be a shortage of almost 42,000 radiologists in the United States in 2033. Credit: HealthCare GE HealthCare is exhibiting more than 40 new innovations during the Radiological Society of North America’s (RSNA) Annual Meeting in Chicago, 26-30 November 2023. The range of innovations aim to […]
Roche expands Elecsys portfolio and launches Hepatitis B immunoassay
Roche’s Elecsys HBeAg quant test can detect the presence of hepatitis B e antigen (HBeAg) in human serum and plasma to diagnose hepatitis B. Image Credit: Sundry Photography / Shutterstock. Roche has launched a qualitative and quantitative immunoassay, Elecsys HBeAg quant, to diagnose and monitor hepatitis B. The test can detect the presence of hepatitis […]
Telehealth app pledges to cut winter hospitalisations by 52%
GlobalData’s Medical Device Intelligence Centre has found that the remote patient monitoring market will reach $760 million by 2030, up from $548.90 million in 2020. Credit: Shutterstock / Iryna Imago Home-based healthcare provider, Cera, has committed to saving the UK’s National Health Service (NHS) £100m ($126m) using virtual consultations employing artificial intelligence (AI) to reduce […]
SHL Telemedicine launches SmartHeart membership in US
According to a report on GlobalData’s Medical Device Intelligence Center, the remote patient monitoring market will reach $760m by 2030. Credit: ArtemisDiana via Getty Images. SHL TeleMedicine is launching a membership programme in the US for its SmartHeart device to treat post-myocardial infarction (MI) patients. SmartHeart is a battery-powered device with a 12-lead electrocardiogram (ECG) and […]
OrbusNeich acquires majority stake in PT Revass
PT distributes cardiovascular intervention products. Credit: MAD.vertise via Shutterstock. OrbusNeich Medical Group Holdings, through its wholly owned subsidiary, has acquired an 84% stake in Indonesian distributor PT Revass Utama Medika. The initial estimated amount for this deal is $15.12m. The actual consideration, anticipated to range between $10.08m and $20.16m, will be determined according to PT […]
Philips introduces new AI-enabled solutions for healthcare providers
The RSNA conference lasts until 29 November. Credit: Koninklijke Philips N.V. Royal Philips has introduced new AI-enabled solutions for healthcare providers at the medical imaging conference, RSNA 2023, in Chicago, US. This conference is held between 26 and 29 November this year. The new solutions include EPIQ Elite 10.0 and Philips Affiniti ultrasound systems, BlueSeal […]