Dexcom (NSDQ:DXCM) announced today that it received FDA clearance for its Dexcom Partner Web application programming interfaces (APIs). The San Diego–based company’s Dexcom Partner Web APIs enable invited third-party developers to integrate real-time continuous glucose monitoring (CGM) data into their digital health apps and devices. Get the full story at our sister site, Drug Delivery Business […]
FDA raises concerns about NuVasive Magec devices
The FDA today issued a notice warning patients, caregivers and healthcare providers of potential issues with Magec devices from NuVasive (NSDQ:NUVA). NuVasive’s Magec, a growing spinal rod system intended for use in children under 10, uses magnets to help correct spinal deformities as the child grows. The company designed Magec to help avoid multiple operations while […]
Vivasure Medical initiates development of sutureless venous closure device
Vivasure Medical announced today that it launched a development program for its PerQseal Blue investigational product. Galway, Ireland-based Vivasure designed PerQseal Blue for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, including transcatheter mitral valve repair/replacement (TMVR) and transcatheter tricuspid valve repair/replacement (TTVR). According to a news release, the company based […]
Imperative Care raises $260M Series D for stroke care tech, acquires Truvic Medical
Imperative Care announced today that it closed a $260 million Series D financing round to support its stroke care technologies. Campbell, Calif.-based Imperative Care had its funding led by D1 Capital Partners, with new investors HealthCor Investments and Innovatus Capital Partners also joining the round. In addition, existing investors Ally Bridge Group, Bain Capital Life […]
FDA grants iStar Medical IDE for glaucoma implant pivotal trial
iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, which will enroll over 350 patients with primary open-angle glaucoma. Get the full story at our sister site, Drug […]
FDA advisory panel gives positive ruling on TransMedics OCS Liver System
TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote supporting approval for its OCS Liver System. Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review […]
Pear Therapeutics touts 9-month data for reSET-O
Pear Therapeutics today touted results from an extended retrospective analysis of real-world data for its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics developed its reSET-O prescription digital therapeutic (PDT) for treating opioid use disorder (OUD). Get the full story at our sister site, Drug Delivery Business News.
CoapTech wins CE mark for ultrasound gastrostomy system
CoapTech announced today that it received CE mark approval and an approved CPT procedure code for its PUMA-G ultrasound gastrostomy system. Baltimore-based CoapTech’s PUMA platform consists of minimally invasive devices designed to enable ultrasound for use in procedures in hollow organs of the body in which it was previously impossible or unsafe to do so, […]
Nasdaq halts trading of TransMedics stock with FDA set to review OCS Liver System
TransMedics (NSDQ:TMDX) announced today that the Nasdaq market halted trading of the company’s common stock. Andover, Mass.-based TransMedics, which develops organ transplant transportation platforms, saw its common stock close down -5.3% at $31.69 yesterday. The company awaits the outcome of today’s meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory […]
Eli Lilly acquires glucose-sensing insulin developer Protomer Technologies
Eli Lilly (NYSE:LLY) announced today that it acquired peptide- and protein-engineering platform developer Protomer Technologies. The potential value of the transaction is over $1 billion, depending on the achievement of future development and commercial milestones. Pasadena, Calif.–based Protomer Technologies develops next-generation protein therapeutics designed to identify and synthesize molecules that can sense glucose or other endogenous […]
Stryker launches humeral system as part of new portfolio
Stryker (NYSE:SYK) announced today that it launched the Perform humeral stem as part of its newly introduced Tornier shoulder arthroplasty portfolio. Kalamazoo, Mich.-based Stryker designed its Tornier Perform humeral stem for use in anatomic, reverse and hemiarthroplasty of the shoulder to allow for conversion from an anatomic to a reverse shoulder prosthesis in the case […]