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. […]
Aptar wins FDA clearance for ready-to-use seizure treatment device
AptarGroup today said it won FDA approval for its Unidose Liquid System that treats acute repetitive seizures in people who have epilepsy. The Unidose Liquid System is a device that delivers a nasal rescue treatment that is ready-to-use when and where a seizure cluster occurs. “This approval and successful market launch further demonstrate the broad […]
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 […]
Eitan Group launches preventative maintenance servicing tool for Sapphire infusion pumps
The Eitan Group last week said it launched a new preventative maintenance servicing tool to cut maintenance costs and runtime on its Sapphire infusion pumps. The new FasTestPM (preventative maintenance) replaces Eitan Group subsidiary Q Core’s previous maintenance kit and will allow users to quickly perform full maintenance tests on their Sapphire infusion pumps. Applicable […]
Pixarbio CEO Reynolds convicted in $13m investor fraud case
Pixarbio founder & CEO Frank Reynolds reportedly faces two decades behind bars after a jury yesterday convicted him of defrauding investors of nearly $13 million. Federal authorities arrested Reynolds, longtime friend and Pixarbio employee Jay Herod and PixarBio CIO Kenneth Stromsland in April 2018 on securities fraud charges, claiming they misled investors about the opioid substitute […]
Bryn Pharma raises $18m for nasal epinephrine device
Bryn Pharma said today that it raised nearly $18 million in financing to fund U.S. approval and commercialization for its Bryn-NDS1C bidose epinephrine nasal spray device for treating anaphylaxis. The $17.5 million funding round was the company’s fourth completed financing series and it included $15 million from existing and new investors, while the remaining $2.5 […]
Clearside Biomedical inks $76m licensing deal with Bausch for Xipere
Clearside Biomedical (NSDQ:CLSD) said yesterday that it entered into a license agreement with Bausch Health Ireland (NYSE:BHC) worth up to $76 million for the Xipere device for the treatment of macular edema associated with uveitis. The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device. Bausch agreed to […]
Clearside Biomedical confirms timeline for Xipere
Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported […]
Novartis unit spikes Pear Therapeutics deal
Novartis (NYSE:NVS) unit Sandoz said this week that Pear Therapeutics will take sole responsibility for the commercialization of their prescription digital therapeutics program for treating substance and opioid use disorders. In April 2018, Pear announced that it agreed to deal commercialization rights of its digital therapeutics to Sandoz. The companies did not disclose financial details, but […]
Senzer Pharmaceuticals wins CE Mark for cannabinoid inhaler
Senzer Pharmaceuticals said yesterday that it has received the CE Mark for its cannabinoid inhaler. London-based Senzer said the Class IIa medical device approval, obtained in a joint project with manufacturing partner Europlaz, is the first-ever granted in the cannabinoid space and will allow the company to accelerate its plans to launch in the UK […]
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