Led by a former tobacco company executive, Qnovia looks to offer nicotine replacement therapy through inhaled drug delivery. Brian Quigley spent just over 16 years at tobacco giant Altria. During his time there, he ran two U.S. business units, including the smokeless tobacco business. In July 2020, he joined founder and then-CEO at Qnovia (then […]
Respiratory
Another Philips respiratory devices recall receives a Class I label
The FDA announced today that it is labeling another Philips Respironics recall as Class I, its most serious classification. The new recall involves 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines may contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk […]
Pulmatrix completes patient dosing for inhaled migraine treatment
Pulmatrix (Nasdaq:PULM) announced today that all subjects completed dosing in a trial of its orally inhaled migraine treatment. Lexington, Massachusetts-based Pulmatrix is evaluating PUR3100 in a Phase 1 trial using the patented iSperse technology. All subjects completed dosing of the novel orally inhaled formulation of dihydroergotamine (DHE). The company expects Phase 1 data in the […]
Three-way merger forms pulsed electric field therapy company Galvanize Therapeutics
Galvanize Therapeutics today announced a three-way merger and $100 million in funding for its pulsed electric field (PEF) technology. Life sciences venture capital firm Apple Tree Partners (ATP) created and incubated Galvanize. Initially, three companies — Gala Therapeutics, Galaxy Medical and Galvanize — comprised the incubation. They recently merged into one firm under the Galvanize […]
Philip Morris hires two former FDA officials as it pushes ‘smoke-free’ development
Cigarette maker Philip Morris (NYSE:PM) announced today that it appointed two former FDA officials to leadership positions. Dr. Badrul Chowdhury is the company’s new chief life sciences officer for smoke-free products. Dr. Matthew Holman joins as VP of U.S. scientific engagement and regulatory strategy. Both appointments fall in line with the company’s efforts to push […]
The 10 largest medtech employers — and what their employees really think
Employees of the 10 largest medtech employers are happy to be a part of companies having a positive impact on patient populations. That was one major takeaway as MassDevice compiled some current and former employee reviews posted on Glassdoor. Medtronic, Philips and Johnson & Johnson MedTech top the list of largest medtech employers. The 10 […]
Lyra Therapeutics enrolls first patient in Phase 3 chronic rhinosinusitis trial
Lyra Therapeutics (Nasdaq:LYRA) announced today that it enrolled the first patient in its Phase 3 Enlighten II clinical trial. Enlighten II is evaluating the company’s LYR-210 in adult patients with chronic rhinosinusitis (CRS). Lyra’s proprietary XTreo platform delivers LYR-210. Watertown, Massachusetts-based Lyra designed the proprietary XTreo platform for precise, sustained and local delivery. The platform […]
FDA clears next-generation RhinAer stylus from Aerin Medical
Aerin Medical announced today that it received FDA 510(k) clearance and launched its next-generation RhinAer stylus. Sunnyvale, California-based Aerin designed the system as a non-invasive, temperature-controlled radiofrequency technology. It treats the causes of rhinorrhea (runny nose), post-nasal drip and congestion associated with chronic rhinitis in a single session. The new RhinAer provides physicians with improved […]
FDA clears Medtronic RespArray patient monitor for procedural sedation and medical-surgical units
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its RespArray patient monitor. Fridley, Minnesota-based Medtronic designed RespArray for procedural sedation and medical-surgical units. It features Nellcor pulse oximetry and Microstream capnography. RespArray also offers electrocardiogram (ECG), non-invasive blood pressure (NiBP) and temperature monitoring. Algorithms help to detect respiratory compromise early and reduce […]
Study backs RejuvenAir treatment for bronchitis from CSA Medical
CSA Medical announced today that study data support the use of its RejuvenAir system for treating chronic bronchitis. Boston-based CSA Medical designed its metered cryospray (MCS) treatment using the RejuvenAir System. RejuvenAir, a proprietary interventional liquid nitrogen spray cryotherapy system, utilize software-driven dosimetry and specialty catheter. Get the full story at our sister site, Drug Delivery […]
Philips, DOJ settle for $24.8M over Respironics kickback allegations
Philips (NYSE:PHG) today agreed to pay more than $24 million to resolve False Claims Act allegations revolving around kickbacks. The U.S. Department of Justice (DOJ) alleged that Philips RS North America (formerly Respironics) misled federal healthcare programs by paying kickbacks to durable medical equipment (DME) suppliers. Affected programs included Medicare, Medicaid and TRICARE, the healthcare […]