DexCom launches connected CGM system with new AID feature
Leveraging a wearable sensor and transmitter, Dexcom G6 continuously measures and sends glucose levels wirelessly to a smart device or receiver. Credit: Andrey_Popov / Shutterstock.com. DexCom has initiated the Dexcom G6 Real-Time Continuous Glucose Monitoring System (rt-CGM), which can connect with the Omnipod 5 automated insulin delivery (AID) System, in Germany. Claimed to be the […]
Q&A: The facts about the PATCH Act
On December 29th, 2022, the Act was signed into US law and from March 29, 2023, a premarket application or submission of cyber devices had to contain all information required by the FDA. Credit: Panchenko Vladimir/Shutterstock As the October 1st deadline for the new US Protecting and Transforming Cyber Health Care Act of 2022 (PATCH […]
Beta Bionics collects $100m in Series D funding
The latest funding will be used to improve Beta Bionics’ diabetes technology and expand its market presence. Credit: Kateryna Novikova/Shutterstock Diabetes management company Beta Bionics has closed a Series D funding round after reaching its financing goal of $100 million in new equity capital. Two new investors, Sands Capital and Omega Funds co-led the financing […]
UC Santa Cruz develops new liquid biopsy for cancer diagnosis
The RNA liquid biopsy platform has been developed to identify both protein-coding RNA and RNA dark matter in the blood. Credit: National Cancer Institute on Unsplash. The University of California, Santa Cruz (UC Santa Cruz) Biomolecular Engineering assistant professor Daniel Kim and his lab have developed an RNA liquid biopsy platform, which identifies both protein-coding […]
The benefits of using an app to manage gestational diabetes: Niki’s story
When Niki found out she was pregnant again it was a bit of a surprise. “I thought I was menopausal,” she reveals, “it was such a shock!” Niki was also a little embarrassed, she confesses. After all, she was working as a midwife, and is a trained nurse. As a ‘geriatric mother’ – a rather […]
Another Class I recall for Getinge’s IABPs
This is the third Class I recall for Getinge’s troubled IABP device this month totalling six recalls this year to date. The US Food and Drug Administration (FDA) has given a Class I recall certification to Getinge’s Cardiosave Hybrid and Rescue Intra-aortic balloon pumps (IABP) after several issues emerged that are putting patients at risk […]
23andMe expands cancer at-home genetic report
The BRCA1 and BRCA2 genes have been associated with an increased risk of developing breast, ovarian, prostate, and pancreatic cancer. Image Credit: Victor Moussa / Shutterstock. The US Food and Drug Administration (FDA) has issued a 510(k) clearance to 23andMe to include an additional 41 variants of BRCA1 and BRCA2 genes as part of its […]
CytoSorbents receives expanded registration for CytoSorb
Shock is a serious complication of critical illness and cardiac surgery. Credit: Alexander Grey on Unsplash. CytoSorbents has received an expanded medical device registration from the Brazilian Health Regulatory Agency (ANVISA) for its CytoSorb blood purification technology for the treatment of shock. Shock is a serious complication of critical illness and cardiac surgery. It causes […]
Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs
Novo Nordisk is now the second largest company in Europe. Credit: JHVEPhoto / Shutterstock.com Novo Nordisk, manufacturer of GLP-1 antagonist drugs Wegovy and Ozempic, now has a higher market capitalisation than the yearly GDP of its home country, Denmark. At the time of writing the International Monetary Fund projects Denmark’s 2023 GDP to reach $405.6bn, […]
Aspira, The University of Oxford sign procurement agreement
EndoCheck is a non-invasive blood test under development for endometriosis diagnosis. Credit: Tatiana from Pixabay. Aspira Women’s Health and The University of Oxford have signed a material transfer agreement for serum samples. Under the agreement, Aspira will receive serum samples from the university for verifying and validating its endometriosis blood test algorithms. Using these samples, […]