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Huma will leverage Google Cloud’s generative artificial intelligence (AI) technology to streamline its disease-management digital product – a Software as Medical Device (SaMD) platform. 

The digital health company said it plans to use Google Cloud’s generative AI (GenAI) to enhance the disease management platform, which centralises patient data so it can be assessed by clinicians or self-managed by patients themselves. 

The platform, which provides enhanced decision-making tools for diagnostic recommendations and treatment, will now have GenAI to automate the generation of clinical summary reports from incoming data. 

The New York-based company also says GenAI will improve communication between patients and providers, allowing more tailored care plans. Huma is also exploring optimising patient triaging by employing the use of Google Cloud’s Med-PaLM 2 – a large language model developed for the healthcare sector.  

Along with medical imaging and digital diagnostics, digital health platform is one of the key drivers of AI uptake in healthcare. GlobalData predicts the global market for specialised AI applications will be worth $146 billion by 2030.  

In a bid to boost its certification capacity for medical devices in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies. The move, which almost doubles the agency’s current roster, sees TÜV SÜD, Intertek, and TÜV Rheinland UK join existing bodies BSI Assurance UK, DEKRA Certification UK, SGS United Kingdom and UL International. 

The role of an approved body is to conduct conformity assessments on medical devices submitted by manufacturers for the Great Britain market. Focus on approved bodies intensified following Britain’s legislative cut-off from Europe during Brexit. There has been a toing and froing of regulatory acceptance since the MHRA became the overseer of whether medical devices were approved for the British market. 

The UK government had given an extended timeframe in which CE-marked devices could be placed on the British market. And despite recent concessions in other industries such as toys and radios, makers of medical devices still have a grace period until 30 June 2028 or 30 June 2030 depending on which EU directive their device falls under. 

The addition of three new UK Approved Bodies aims to bolster UKCA certification capabilities ahead of the CE-mark transition deadline. 

UK gynaecological startup Daye will be able to reach women’s and girls’ health across the pond, after the US Food and Drug Administration (FDA) cleared the company’s Nude Tampon for marketing as a medical device. 

The female-led company founded in 2017, which is best known for inventing a cannabidiol (CBD) tampon, has developed its Nude Tampons with gamma ray sanitisation. A safe way of sterilising the products, Daye says its product is the only tampon on the market sanitised this way. 

Killing pathogens and ensuring cleanliness of tampons can reduce the chances of toxic shock syndrome – a rare but potentially life-threatening condition that has become associated with tampon and menstrual cup use. Though the syndrome can have other causes, Daye adds that the gamma-irradiation also reduces the risk of other vaginal infections like thrush and bacterial vaginosis. 

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 BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report. 

23andMe first received FDA clearance for at-home genetic testing of three variants of BRCA1 and BRCA2 genes in 2018. The company plans to release the updated report by the end of next year. 

The news led to a spike in the 23andMe stock price, it was up by more than 18% in pre-market trading on 1 September, compared to the market close on the previous day. 23andMe’s market cap stands at $519.74m. 

The BRCA1 and BRCA2 genes have been associated with an increased risk of developing breast, ovarian, prostate, and pancreatic cancer. The US-based company also received the first-ever Predetermined Change Control Plan (PCCP), which outlines the protocols and acceptance criteria to validate BRCA1 and BRCA2 variants.  

Researchers plan to send a 3D printed artificial heart to the international space station (ISS) by 2025 to better understand the effects of ageing and cardiovascular diseases in space. 

The AstroCardia Project is made up of five Belgian companies which include Space Applications Services, SCK CEN, QbD Group, BIO INX and Antleron. The companies will combine their expertise to run a study on the effects of ageing on the heart in space using a bioprint of a miniature ‘heart on a chip’ with an artificial circulatory system. 

The device, which is only a few square millimetres in size, uses ink made up of stem cells and biomaterials that can develop into any cell in the body. These cells organise themselves into a developing cardiac organoid which will work with the artificial circulatory system. The test will run for at least six weeks and be monitored in real-time at the ISS.