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 […]
Tusker Medical’s pediatric ear tubes land breakthrough device designation
The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]
Medtronic warns patients of MiniMed insulin pump safety issue
Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin. In a letter to patients, the company said that the pump’s insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping […]
BD launches syringe-autoinjector combo
Becton Dickinson (NYSE:BDX) today announced the launch of the BD Intevia 1mL two-step disposable autoinjector, which combines an autoinjector and pre-fillable syringe in one integrated system. BD Intevia disposable autoinjector is a 2-step push-on-skin device that is designed to effectively and safely inject a variety of drugs of different viscosities up to 35cP and different […]
Aptar Pharma’s two-dose nasal spray device to deliver epinephrine
Aptar Pharma has entered an agreement for Bryn Pharma to use Aptar’s Bidose (BDS) nasal device to deliver Bryn’s epinephrine nasal spray (BRYN-NDS1C). Crystal Lake, Ill.-based Aptar’s Bidose tech enables two-shot nasal drug delivery and will replace the need to carry two epinephrine auto-injectors, according to the companies. Last March, Aptar won FDA approval to […]
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