Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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Sterigenics said it picked up microbiology testing service provider Nelson Laboratories for an undisclosed amount.
Salt Lake City, Utah-based Nelson Labs provides microbiology testing services for the medical device, pharmaceutical and tissue industries and employs 570 individuals, including 300 scientists and 60 registered specialist microbiologists. Read more
Proteus Digital Health yesterday presented interim results from a study of its Proteus Discover for patients with uncontrolled hypertension and type 2 diabetes, claiming use of the system raised patient compliance, lowered blood pressure and reduced low-density lipoprotein-cholesterol.
The Chicago-based company’s Proteus discover operates through the use of an ingestible sensor, the size of a grain of sand, which is activated when it reaches the stomach and communicates with a wearable sensor patch which records time of ingestion and personalized data such as heart rate, physical activity and rest. The data can be seen by a patient through a mobile app, which can be shared with healthcare professionals to optimize patient treatment. Read more
SurModics said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device coating provider to medical device maker.
The FDA granted investigational device exemption for the trial late last year, the Eden Prairie, Minn.-based company said. The 1st-in-human study is slated to enroll 15 patients to examine the safety & usability of the SurVeil device before the design is finalized, SurModics said. Read more
Bracco Diagnostics said yesterday it won FDA premarket approval for its Lumason ultrasound imaging agent, now indicated for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.
Marketed in other countries as SonoVue, Lumason is a contrast agent made up of gas-filled microbubbles, or microspheres, that reflect sound waves to enhance the image. Lumason was previously approved for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and improve cardiac imaging. Read more
Medtronic remains unfazed by the U.S. Treasury Dept.’s push to rein in so-called “inversion” mergers, which allow American companies to re-organized under foreign jurisdictions, after the agency issued new rules on the deals this week.
The U.S. government has grappled with a wave of inversions in recent years, including last year’s $50 billion union of Medtronic and Covidien, which was domiciled in Ireland. Reincorporating overseas allows American companies to slash their tax bills even though their core operations and management stay here. Several U.S. presidential candidates, including Republican Donald Trump and Democrat Hillary Clinton, have seized on the issue in their campaigns. President Barack Obama, a Democrat, has called repeatedly for action by the Republican-controlled U.S. Congress on inversions, but lawmakers have done little. Read more