SAN FRANCISCO – The FDA has been following the lead of the many proactive diabetes patients who have hacked together devices and software to get the equipment they need. In 2018, the agency started to approve interoperable diabetes devices with the Dexcom G6 integrated continuous glucose monitoring (iCGM) system. An interoperable insulin pump from Tandem Diabetes Care got the next nod from FDA last year. Here at the J.P. Morgan Healthcare Conference, Insulet Corp. said it aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod Horizon. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. In combination, the devices will operate as a closed loop system to automatically adjust insulin dosage over time in response to blood glucose levels.
SAN FRANCISCO – Major genetic research efforts designed to encompass millions of people globally have been setting up their infrastructure in recent years to serve both researchers and patients. This work is being done by major national initiatives, such as All of Us in the U.S. and Genomics England in the U.K., as well as by health care systems such as Intermountain and Kaiser. They are poised to start returning data – and are trying to refine their approaches to everything from privacy to recruitment to data sharing across organizations. A panel at the J.P. Morgan Healthcare conference examined the prospects and perils of these population level genetic projects.
LONDON – The European Commission has published new guidelines on cybersecurity for medical devices, putting flesh on the bones of the requirements in the Medical Devices Regulation (MDR) that comes into force in May. The guidelines have been drawn up by the Medical Device Coordination Group, a body representing all EU member states, which has a brief to ensure MDR and its counterpart, the In Vitro Diagnostic Devices Regulation (IVDR) are applied in a harmonized way across Europe. Industry and patient representatives have observer status at the group’s meetings.
HONG KONG – South Korean med tech Olive Healthcare Inc. has attracted ₩8 billion ($6.91 million) in series B funding. The Seoul-based company is focused on abdominal fat scanning and breast cancer diagnosis, using nonradiative and noninvasive near infrared technology, AI algorithms, and big data processing for a customized medical service. Venture capital firms including Partners Investment, Hyundai Investment Partners Co. Ltd., Pathfinder H Co. Ltd. and a major Korean bank, Shihan Bank Co. Ltd., participated in the funding.
Accellix, Arpeggio Bio, Bioprotect, Contextual Genomics, Doctorsforme, Eisai, Elt Sight, Emboline, Eorla, Intelgenx, Iterative Scopes, Lifesignals, Lincotek, Neovasc, PCORI, Personal Genome Diagnostics, Prognos Health, Transaction Data Systems Management, Windgap Medical