Dance Biopharm today said it rebranded as Aerami Therapeutics and will move its headquarters to Durham, N.C. The rebranding comes as the company seeks strategic partners for its Dance 501 inhaled human insulin. The company also hopes the rebranding will help progress into pivotal registration studies and expand to include inhaled therapeutics for endocrinology diseases. […]
Japan OKs OrbusNeich’s Combo Plus stent
OrbusNeich Medical today said it won market approval in Japan for its Combo Plus coronary stent. The Combo Plus stent is designed to address the risk of stent thrombosis associated with delayed healing in conventional drug-eluting stents. The Combo Plus DES uses endothelial progenitor cell capture technology and abluminal sirolimus drug elution delivered from a […]
Ocular Therapeutix doses first patients in pivotal allergic conjunctivitis trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) yesterday said it dosed the first patients in a Phase 3 clinical trial of its Dextenza drug-device combination. The U.S.-based Phase 3 clinical trial is a multi-center, 1:1 randomized, double-masked, placebo-controlled trial slated to enroll 80 patients. The study will evaluate Dextenza 0.4mg to treat allergic conjunctivitis and ocular itching versus a placebo […]
Valeritas touts h-Patch CBD study
Valeritas (NSDQ:VLRX) today announced positive results from its preclinical pharmacokinetic study of cannabidiol subcutaneous infusion. The study focused on delivering cannabidiol (CBD) through subcutaneous infusion through the company’s h-Patch Wearable Device. The results were presented at the CannMed Conference in Pasadena, Calif. Results from the study showed rapid and robust absorption and distribution of 40mg of […]
FDA finalizes guidance on special and abbreviated 510(k) programs
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Special and Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions. […]
EU Commission lays out plan on expert panels under MDR, IVDR
By Stewart Eisenhart, Emergo Group The European Commission has clarified its designation process for appointing expert panels to support regulators, Notified Bodies and other entities meet requirements and obligations of the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story here at the Emergo Group’s blog. The opinions expressed […]
Key questions for medical device companies to tackle gaps in cybersecurity processes
By James Keller, Emergo Group Anyone paying even the slightest attention to today’s media has likely seen numerous reports on cybersecurity risks associated with medical devices. Some reports are overblown, some present more measured concern, and others describe very specific risks such as from major cyber-related product recalls. But there is an overall consensus among […]
What cybersecurity compliance support should look like for medical device developers
By Ken Modeste, Emergo Group For healthcare product and medical device technology developers, ensuring effective support for cybersecurity compliance is becoming a key step in securing regulatory approval and market access. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Saudi Arabia regulators plan new MDMA fees, risk classification system for medical device registrants
By Stewart Eisenhart, Emergo Group Medical device market regulators in Saudi Arabia plan to raise registration fees as well as implement a new device regulatory system in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
Eitan Group inks Canadian distribution deal for Sapphire infusion pumps
Eitan Group today announced it signed a distribution agreement with Canadian Hospital Specialities to distribute its Sapphire infusion pumps in Canada. Through the agreement, Canadian Hospital Specialties will supply and support Israel-based Eitan Group’s Sapphire infusion pumps to hospitals and alternate site customers in Canada. “CHS works to introduce the most advanced medical technology to […]