Upstart Senseonics expects to be the first to introduce a long-term implant to continuously monitor glucose levels in diabetics. It's already under review for a CE mark after disclosing pivotal European data in October. Now, it's detailed the plans for the pivotal U.S. study of its Eversense Continuous Glucose Monitoring System.
After a reverse merger in December, the blood glucose monitor implant company Senseonics is already publicly traded, albeit on the OTC markets. Now, it's filed to raise up to $51.8 million in an IPO-like offering, after which it proposes to bump up to the NYSE market and trade under the ticker symbol "SENS."
San Diego, CA-based startup GlySens expects that its implanted continuous glucose monitor could offer convenient long-term monitoring for diabetes patients. It's been able to use its sensor implant for up to 18 months in the preclinical setting.
Almost one million childhood deaths are attributed to pneumonia annually, leading UNICEF to issue a call in 2011 for product innovation to create a respiratory monitor. Now, Royal Philips is almost ready to launch its Children's Automated Respiration Monitor that is designed to address those needs.
EBR Systems' WiSE leadless pacemaker just earned a CE mark, becoming the first device in the class approved for improving left ventricular function. Medtronic and St. Jude Medical also offer leadless pacemakers, but they are implanted in the heart's right ventricle.
Breast implant company Sientra saw its valuation cut in half on news that its contract manufacturer Silimed has had its CE mark suspended by the U.K. Department of Health. The move came after German regulators conducted an inspection of a Brazilian manufacturing plant--and regulators found that "the surfaces of some implants were contaminated with particles."
Startup Shockwave Medical expects that its Lithoplasty balloon catheters will emerge as a pretreatment for calcified coronary lesions that's used instead of or prior to stenting. Now it's received $40 million to further advance toward that goal.
Menlo Park, CA-based Medina Medical has raised $6.2 million in debt to back its device development for vascular abnormalities, including a device specifically to treat cerebral aneurysms. It still declares itself in stealth mode on its site, despite the fact that it has already disclosed that it received a CE mark.
Medtronic has officially joined the European leadless pacemaker market thanks to the CE-mark approval of its Micra Transcatheter Pacing System. It is one-tenth the size of conventional pacemakers, making it the world's smallest device in the overall category.
St. Jude Medical's transcatheter aortic valve replacement, or TAVR, cardiology device is now commercially available in Europe once again, after its CE mark was suspended following safety concerns about reduced valve leaflet mobility arising from the company's U.S. clinical trials.