New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
Small American device manufacturers are more likely to sell their products only in the U.S., and thus the FDA proposal to more closely align the Quality System Regulation (QSR) with ISO 13485 would seem to place unwarranted demands on these companies.
PARIS – Ziwig SAS has developed the Endotest saliva test, for quickly detecting endometriosis. François Golfier, head of the gynecology-obstetrics department at Angers University Hospital and chairman of the endometriosis committee for the National College of French Gynecologists and Obstetricians, claims this new generation of in vitro diagnostic medical devices is going to be a game-changer “as it finally allows this chronic debilitating disease to be detected sooner and within the space of just a few days.”
The FDA has published an updated guidance for the appeals process at the Center for Devices and Radiological Health, but the issuance of that guidance did not happen in a vacuum. Mark Duval, president of Duval & Associates in Minneapolis, told BioWorld that industry is filing more appeals of premarket decisions of late, an uptick he said is an artifact of the practice of FDA reviewers more commonly asking for additional data for these applications.
Medtronic plc has launched a single-use device for outpatient-based treatment of chronic, obstructive Eustachian tube dysfunction (ETD). Medtronic’s FDA-approved Nuvent system is a manually controlled balloon catheter for insertion into the Eustachian tube canal. Once pressurized, the balloon expands and dilates the Eustachian tube canal to relieve symptoms of ETD.
Dariohealth Corp. and Sanofi U.S., a subsidiary of Paris-based Sanofi SA, inked a strategic agreement that provides Dario with $30 million to speed commercial adoption of the company’s integrated digital therapeutics platform. The company simultaneously announced definitive agreements with institutional investors to purchase approximately 5,342,013 shares of its common stock at $7.49 per share, a deal that will generate about $40 million for the company.
Visby Medical Inc. reeled in more than $100 million in a series E round led by Ping An Voyager Partners. The funds will be used to scale production capacity of Visby’s instrument-free, single-use real-time polymerase chain reaction (RT-PCR) platform from tens to hundreds of thousands of tests per month.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altpep, Diadem.
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