Ortho Clinical Diagnostics CEO Martin Madaus told FierceMedicalDevices in an interview that Ortho has been actively investing in building out as a standalone company, which has dragged on earnings in the near term. But he added that Ortho has returned to revenue growth--and is aiming to get to about a 4% run rate.
The medical device industry has been working on miniaturizing pacemakers so they can be minimally invasively inserted and cause fewer difficulties for patients. Up next likely are closed-loop systems: pacemakers that record patient data, transmit that data externally and enable adjustment based on that data by physicians or even, eventually, on their own as guided by advanced algorithms.
Two of the three largest venture rounds in U.S. life science startups last quarter went to medical device companies. That's a bit of an unusual state of affairs for med tech--which sometimes has the reputation of getting investment in dribs and drabs to back tech that's none too innovative.
The China Food and Drug Administration has issued more than 20 guidance documents on medical device regulation over the last two years as it tightens its oversight of the device industry in the fast-growing market. The chief concern and area of uncertainty revolves around the country's clinical trial regime, especially for devices that are not on an "exempt list." Adding to the confusion, some devices on the list may still require a clinical trial, while others not on the list could get registered and approved without a trial.
Industry and free speech advocates are touting the FDA's concession to drug company Amarin as a sign that they are winning the battle over the constitutionally of off-label promotion. The settlement was no doubt prodded by a series of legal defeats suffered by the FDA, including not just over the Amarin litigation, but also a recent case involving Vascular Solutions' Vari-Lase device to treat varicose veins.
Medical devices got a taste of an IPO market last year that's long been wide open for biotech. That came at the same time that the acquisition appetite for venture-backed device companies held strong. But there's a backlog of device portfolio companies that VCs need to get off their books before they can have any greater appetite for the device category.
Venture capital investment in the U.S. jumped to $59 billion last year--almost twice what it was a scant 5 years ago, according to the latest annual healthcare report from Silicon Valley Bank. But medical devices are capturing an ever-shrinking portion of all that largesse for innovation--down to a mere 4% of that VC total for last year or $2.4 billion, which is roughly right where it was in 2014.
Med tech has been the single hardest place to invest in the entire universe of venture capital-backed industries, said New Enterprises Associates partner Justin Klein during an insightful speech delivered last year at the Maryland Entrepreneurship expo in Baltimore.
Illumina makes waves in China with NGS clinical testing deal; LabCorp buys women's health lab to boost offerings
In this week's Dx Digest, Illumina struck a deal to expand its presence in China, Hologic snagged a CE mark for its test for a common but oft-misdiagnosed sexually transmitted infection, and diagnostics giant LabCorp snatched up medical testing unit Pathology to get its hands on the company's molecular and digital pathology services.
The success of Intuitive Surgical's da Vinci robot for minimally invasive surgery is creating a growing list of "fast followers," but the company believes it has created enough "moats" to fend them off for quite some time, according to Leerink equity analyst Richard Newitter.