Pancreatic cancer is the third leading cause of cancer death in the U.S., in part because many cases aren’t diagnosed until they are advanced. Bluestar Genomics Inc. wants to change that with its epigenomics technology which can detect early pancreatic cancer from a standard blood draw by analyzing cell-free DNA in plasma. Now, the FDA has provided a bump, granting breakthrough device designation to Bluestar’s noninvasive pancreatic cancer detection test in patients with new-onset diabetes. According to the San Diego-based startup, of an estimated 60,000 patients diagnosed with pancreatic cancer in the U.S., nearly a fourth are found to have new-onset diabetes prior to receiving their cancer diagnosis.
Movano Inc. closed its IPO on the Nasdaq Friday, reeling in gross proceeds of $48.9 million. The Pleasanton, Calif.-based startup launched the offering of 8.5 million shares of common stock priced at $5 per share on March 22, with a target of raising $42.5 million. The final tally included the fully exercised over-allotment option by underwriters to purchase an additional 1,275,000 shares.
Insulet Corp. reported positive results from a pivotal trial of its Omnipod 5 automated insulin delivery system for patients with type 1 diabetes. The tubeless, wearable insulin delivery system lowered hemoglobin A1c (HbA1c) – a critical diabetes measure – in children, adolescents, and adults, and improved the time that patients were in the target blood glucose range. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting, which was held virtually this year.
Big name investors think January AI Inc. is onto something sweet with its breakthrough diabetes management technology. Investors added $8.8 million to the company's finances, bringing its total capital raised to date to $21 million. Felicis Ventures, which previously invested in Fitbit and Modern Health, joined Hand Capital and Marc Benioff in the latest round.
TORONTO – Think of it. More than 14,000 facilities boasting 98% of the largest hospital chains across the U.S., two-thirds of skilled nursing facilities and hospice organizations and doctors’ offices. It’s that broad customer base Kent Imaging Inc. will have access to following its Jan. 26 agreement with medical software and analytics giant Net Health Inc., helping to expand the footprint of Kent Imaging’s Snapshot device for assessing non-healing wounds, notably those arising from diabetes.
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
HONG KONG – Votis Subdermal Imaging Technologies Ltd. is developing a diagnostics solution that could prevent the loss of feet among India’s impoverished due to affects of peripheral artery disease (PAD). The company has entered an agreement with India’s Ii Ventures Pte. Ltd. (iiV) to develop a system to screen the largely rural Indian population for PAD.
Nevro Corp. has submitted a premarket approval supplement to the U.S. FDA seeking a green light for its Senza system to treat chronic pain associated with painful diabetic neuropathy (PDN). This submission is expected to allow the company to gain approval and kick off U.S. launch activities for this indication in the second half of next year. Nevro would be tapping into a big market, as diabetes affects roughly 1 in 10 adults in the U.S. and can damage peripheral nerves, resulting in severe pain and numbness in the extremities.
Medtronic plc has reported the launch of the Inpen integrated with real-time Guardian Connect continuous glucose monitoring (CGM) data. Inpen is the first U.S. FDA-cleared smart insulin pen on the market for people on multiple daily injections (MDI). With this integrated system, users will have real-time glucose readings alongside insulin dose information, giving them what they need to manage their diabetes in one view.
Researchers at Ontario’s University of Waterloo have developed a palm-sized device that uses radio waves to read blood glucose levels, as well as artificial intelligence (AI) software to get near instantaneous results.