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1-15 of 19204 results
FDA lifts Staar Surgical warning letter
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has lifted a 2014 warning letter issued to Staar Surgical over design and quality issues at a facility in California.
Patient Care > Surgical & Supplies > News
Medtronic launches updated iPro2 glucose-monitoring app
Medtronic has launched the updated iPro2 myLog App with FoodPrint report to enhance diagnostic continuous glucose monitoring (CGM) evaluation for people with diabetes.
Specialty Devices > Diabetes Care Devices > News
Micrima announces £4.4m raise for breast cancer screening system
By MDBR Staff Writer
Micrima has raised £4.4m in further funding to develop its patented Maria breast cancer screening system, bringing the total amount raised to £10.7m.
Diagnostics > Diagnostic Imaging > News
Roche to buy remaining stake in Foundation Medicine for $2.4bn
By MDBR Staff Writer
Roche has agreed to acquire remaining shares in Foundation Medicine (FMI), a US molecular and genomic analysis company, for $2.4bn.
Technology > Healthcare IT > News
FDA approves Bay Labs' EchoMD AutoEF software product
By MDBR Staff Writer
Bay Labs has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its EchoMD AutoEF software for the fully automated clip selection and calculation of left ventricular ejection fraction (EF).
Specialty Devices > Cardiovascular Devices > News
ZipLine Medical raises $9m for surgical skin closure products
Non-invasive wound closure products developer ZipLine Medical has closed $9m growth financing led by existing investor MVM Partners.
Patient Care > Wound Care Management > News
OrthoGrid launches HipGrid Nine system for outpatient total hip replacement
By MDBR Staff Writer
OrthoGrid Systems has introduced its new patent-protected HipGrid Nine system for outpatient total hip replacement.
Specialty Devices > Orthopedic Devices > News
VentureMed starts enrollment in FLEX scoring catheter arteriovenous access site study
VentureMed Group has announced initial enrollment in a new non-randomized, single-site, prospective study to evaluate the safety and efficacy of the FLEX scoring catheter with a drug coated balloon (DCB) balloon in the maintenance of arteriovenous access sites.
Specialty Devices > Drug Delivery Devices > News
Elekta secures CE mark for magnetic resonance radiation therapy system
By MDBR Staff Writer
Sweden-based Elekta has secured CE mark approval for its Unity magnetic resonance radiation therapy (MR/RT) system.
Diagnostics > Diagnostic Imaging > News
Avedro enrolls first patient in phase 3 Epi-on cross-linking trial
By MDBR Staff Writer
Avedro has started patient enrollment in a phase 3 clinical trial to evaluate the safety and efficacy of an epithelium-on(epi-on) corneal collagen cross-linking procedure to treat patients with progressive keratoconus.
News
Johnson & Johnson Vision secures FDA nod for iDesign Lasik device
By MDBR Staff Writer
Johnson & Johnson Vision’s iDESIGN Refractive Studio LASIK platform has been approved by the US Food and Drug Administration (FDA).
News
FDA panel recommends against approval of BTG’s Elevair lung implant
By MDBR Staff Writer
A US Food and Drug Administration (FDA) advisory committee panel has voted against the approval of BTG's Elevair Endobronchial Coil System for the treatment of people with severe emphysema.
Specialty Devices > Anesthesia & Respiratory Devices > News
Zeiss unveils next-generation Visulas green photocoagulation laser
By MDBR Staff Writer
Carl Zeiss Meditec has unveiled next-generation ophthalmic laser, Visulas green, at this year’s World Ophthalmology Congress in Barcelona, Spain.
Patient Care > Patient Monitoring > News
amg International gets CE mark for ARCHIMEDES biodegradable biliary and pancreatic stent
amg International, a wholly owned subsidiary of, Q3 Medical Devices, has received CE mark approval for the ARCHIMEDES Biodegradable Biliary and Pancreatic Stent, allowing the company to begin selling the product in Europe and other markets.
Patient Care > Patient Monitoring > News
Medtronic gets FDA nod for new lengths of IN.PACT Admiral drug-coated balloon
By MDBR Staff Writer
Medtronic has secured approval from the US Food and Drug Administration (FDA) for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).
Specialty Devices > Drug Delivery Devices > News
1-15 of 19204 results