CE Mark

Latest Headlines

Latest Headlines

Roche to sell Senseonics implantable glucose sensor system in some EU countries

Roche's Diabetes Care has signed a deal with implantable glucose sensor company Senseonics to sell its Eversense Continuous Glucose Monitoring System in Germany, Italy and the Netherlands. The deal comes just after a CE mark for the system earlier this month.

Allurion raises $6M to back ingestible weight-loss balloon; pivotal U.S. trials may start in 2017

The market for intragastric balloons to enable weight loss is just getting started in the U.S. after a pair of FDA approvals last summer for the first devices in this category--although it's been in full swing in Europe for years. The FDA-approved options are placed and removed endoscopically--but the newest iteration is an ingestible device that is filled with liquid after it's ingested into the stomach.

Startup slated to launch injectable, one-year tissue oxygen sensor this year in EU

Profusa snagged more than $13 million in venture backing and added a Google VC to its board late last year. Now, it's readying to debut its first product: the Lumee Oxygen Sensing System. The injectable biosensor measures dissolved oxygen in the tissue.

GERD neurostim startup nabs $25M to back ex-U.S. sales, conduct U.S. pivotal trial

Gastroesophageal reflux disease (GERD) is a common indication that's poorly served by existing drug therapies. Now Dutch startup EndoStim has gotten a $25 million Series D infusion to market its neurostimulation device to treat GERD outside the U.S. and to start a pivotal trial within it to gain FDA approval.

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.