The FDA is seeking comment from sponsors of combination products on how they want the agency to respond to their scientific and regulatory questions. Their responses will help shape a new draft guidance, according to the agency. The FDA defines a combination product as one composed of any combination of a drug, device and/or a […]
Medtronic adds AI-fueled Klue to its diabetes management lineup
Medtronic (NYSE:MDT) said today it has completed the acquisition of Klue, a San Jose, Calif.-based software company that tracks people’s eating in real-time and analyzes it with artificial intelligence (AI) to help control diabetes. Medtronic plans to incorporate Klue’s technology into its Personalized Closed Loop (PCL) insulin pump system, which won FDA breakthrough device designation […]
Dexcom CEO apologizes for remote monitoring outage
Dexcom (NSDQ:DXCM) CEO Kevin Sayer publicly apologized on Friday for an outage over Thanksgiving weekend that cut off users’ ability to share glucose monitoring data with caregivers and loved ones. The Dexcom Follow app normally allows users of the company’s G6 continuous glucose monitor to share that data with up to 10 people, according to the […]
FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller
The FDA today cleared the Tandem Diabetes Care (NSDQ:TNDM) t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The agency also granted De Novo clearance to the Control-IQ device, which is compatible with a variety of continuous glucose monitors and insulin pumps. The t:slim system, which also includes the recently […]
Senate confirms Dr. Stephen Hahn to lead FDA
The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer at Houston’s […]
Beta Bionics’ bionic pancreas wins breakthrough status from FDA
The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]
Proteus Digital Health restructuring amid reported funding woes
Proteus Digital Health said today that it is restructuring, reportedly because it failed to close a $100 million funding round. A report by CNBC said the Redwood City, Calif.-based company missed the funding target. Once valued at $1.5 billion, the company previously raised $420 million from investors including Novartis Venture Fund and Kaiser Permanente Ventures, according to an […]
Dexcom warns of potential danger to European app users
Dexcom (NSDQ:DXCM) is warning European customers who have failed to updated the G6 iOS app for their G6 continuous glucose monitor that they may not receive scheduled alerts of high or low blood sugar. Failure to update to version 1.5.4 of the app may cause alarms and alerts from the G6 continuous glucose monitor to […]
Report: 3M may sell off its drug-delivery business for $1 billion
3M (NYSE:MMM)may try to sell off its drug-delivery business in a deal that could fetch $1 billion, according to a report by Bloomberg. The drug delivery division makes transdermal drug patches, microneedle delivery systems, nasal devices, oral inhalers and packaging films for drug delivery. 3M is also developing a smart inhaler and is looking for […]
‘Hubble Space Telescope’ for genomics could yield new drugs, materials
Researchers in Spain have developed a new genomics tool that can classify how species are related to each other at far larger scales than previously possible and may yield new drugs, materials and foods — and pinpoint strategies for saving species at risk of extinction. Heralded as a “Hubble Space Telescope” of genomics, the technology […]
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