CE Mark

Latest Headlines

Latest Headlines

Fujifilm gets FDA nod for first ultrahigh-frequency ultrasound

Ultrasound images are notoriously difficult to discern--often unintelligible to anyone but the most experienced technicians. Fujifilm is looking to fine-tune ultrasound imaging. It's gotten FDA clearance for the first high-frequency ultrasound imaging system, Vevo MD.

Belgian startup raises €10M to back CE mark trial for micro-invasive glaucoma implant

iStar Medical raised a €10 million ($11.4 million) Series B round to fund a study to support a CE mark for its latest product. Its MiniJect is an injected implant that is designed to reduce intraocular pressure in glaucoma patients by improving aqueous humor outflow from the anterior chamber to the suprachoroidal space.

NEA's Senseonics aims to submit to FDA for diabetic monitor implant next half, as it raises $45M

Founded more than 20 years ago, glucose monitor implant startup Senseonicsy is now hoping that it can get regulators to sign off on its continuous glucose monitor Eversense that's based on a tiny implant to track diabetics for up to 90 days. That's much longer than the typical 5- to 7-day span that's available for popular patch-based CGMs.

Israeli PolyPid raises $22M for clinical trials of anti-infective surgical products

PolyPid expects to use a $22 million cash infusion to get its surgical drug reservoir lead candidate into Phase III testing, while completing a trial for its doxycycline-loaded synthetic bone substitute. The latter, for BonyPid-1000, is expected to be sufficient to gain a CE mark by next year.

Boston Sci nabs first CE mark for drug-polymer combo stent for above-the-knee PAD

Boston Scientific won a CE mark for its Eluvia Drug-Eluting Vascular Stent System to treat peripheral artery disease (PAD) patients with narrowing of the arteries above the knee. It will launch the product immediately in the EU and has already started a pivotal trial aimed at U.S. and Asia approvals, with primary endpoint data due in early 2018.

U.S. pivotal trial starts for Senseonics glucose monitor implant with data due in June

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.

NEA to test 2016 public waters with up to $52M Senseonics offering

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."

GlySens nabs $20M Series D to back CE mark for continuous glucose monitor implant

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.

Philips to launch pneumonia Dx wearable to prevent child deaths in poorer countries

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.

Europe grants its first CE mark for leadless pacemaker to treat left ventricle

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.