Ortho Clinical Diagnostics said yesterday that its Vitros insulin assay and calibrators won 510(k) clearance from the FDA. The Raritan, N.J.-based company reported that the diabetes and pre-diabetes diagnostic test is slated to be commercially available in the 3rd quarter of this year. The Vitros insulin assay is part of Ortho’s diagnostic platform for diabetes, […]
Regulatory/Compliance
FDA guidance explains electronic records for medical device clinical trials
By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. 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 reflect […]
FDA commissioner proposes new program for digital health product regulations
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to roll out a new program for mobile medical apps and related digital health products in order to clarify the agency’s regulatory scope regarding these technologies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Medtech stories we missed this week: June 23, 2017
From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for […]
FDA approves diagnostic that simultaneously screens for multiple cancer biomarkers
The FDA said today that it awarded premarket approval to Thermo Fisher Scientific‘s (NYSE:TMO) next-gen sequencing-based test that can simultaneously screen tumor samples for biomarkers associated with 3 approved therapies for non-small cell lung cancer. The company’s Oncomine Dx Target Test evaluates 23 genes associated with non-small cell lung cancer. The tests results could help […]
BioDelivery wins Health Canada approval for Belbuca pain relief product
BioDelivery Sciences International (NSDQ:BDSI) said today that Health Canada approved its buprenorphine hydrochloride buccal film, Belbuca, for the management of pain severe enough to necessitate daily, long-term opioid treatment and for which alternative management options are inadequate. The company said it plans to commercialize Belbuca in Canada through an unnamed partner and that the launch […]
Brazilian medical device regulators change registration submission formats
By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has adjusted its electronic submission policy for marketing authorization applications, now accepting both electronic and paper formats of documents. 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 reflect […]
FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label. The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk […]
pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency. Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of […]
Another extended-release ADHD drug wins FDA nod
Days after Neos Therapeutics (NSDQ:NEOS) nabbed U.S. regulatory approval for its controlled-release formulation of methylphenidate, Shire (NSDQ:SHPG) said it won a nod from the FDA for its long-acting ADHD drug. The drug, Mydayis, is made up of the same active ingredient in Shire’s ADHD treatment Adderall XR – amphetamine – but it is designed to last up to […]