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Imaging

Medtech stories we missed this week: May 25, 2018

May 25, 2018 By Danielle Kirsh

missedmedtech-1027

From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Bonesupport, collagenmatrix, crossroadsextremitysystems, Implanet, maunakea, MC10, Medacta, xablecath

Medtech stories we missed this week: May 11, 2018

May 11, 2018 By Danielle Kirsh

missed-medtech-0511

From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau of […]

Filed Under: Cardiovascular, Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Regulatory/Compliance Tagged With: brainsway, conavi, Exact Imaging, innovativehealth, medtech, perahealth, qtmedical, reshapemedical

Medtech stories we missed this week: April 20, 2018

April 20, 2018 By Danielle Kirsh

missed-medtech-0420

From CHF Solutions’ new Italian distribution deal to Masimo’s CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. CHF Solutions signs Italian distribution deal CHF Solutions announced in an April 17 press release that it has signed a new distribution agreement with TRX Italy to distribute […]

Filed Under: Business/Financial News, Diagnostics, Featured, Hospital Care, Imaging, Implants, Regulatory/Compliance Tagged With: chfsolutions, corelink, konicaminolta, Masimo, Varian Medical Systems

Study: PET imaging agent could help predict depression drug’s efficacy

April 6, 2018 By Sarah Faulkner

Imaging agent for depression

Researchers have identified a positron emission tomography imaging agent that could identify the patients that are more likely to benefit from a drug designed to treat major depressive disorder, according to a study published this month in The Journal of Nuclear Medicine. The C-DASB tracer targets a protein, 5-HTT, found in the part of a person’s […]

Filed Under: Featured, Imaging, Neurological, Pharmaceuticals Tagged With: National Institutes of Health

Fine-tuning formulation with Fluid Imaging Technologies’ FlowCam

April 6, 2018 By Sarah Faulkner

Fluid Imaging Technologies FlowCam

After seven people died in 2013 from serious allergic reactions to Omontys, an injectable anemia drug marketed by Takeda Pharmaceutical (TYO:4502) and Affymax, the companies recalled the product and regulators launched an investigation to find out the cause of such an unexpected rate of anaphylaxis. Omontys was made and cleared in a single-use vial and a multi-use […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Imaging, Pharmaceuticals, Regulatory/Compliance Tagged With: fluidimagingtechnologies, Mayo Clinic, Takeda Pharmaceutical Co

Medtech stories we missed this week: April 6, 2018

April 6, 2018 By Danielle Kirsh

missed-medtech-0406

From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Regulatory/Compliance Tagged With: asahiintecc, aziyobiologics, Biotronik, chfsolutions, Guided Therapeutics, hypermed, instrumedsurgical, johnsonandjohnson, medtech, NanoVibronix

This new technology could help surgeons clear out leftover cancer cells

March 27, 2018 By Sarah Faulkner

In some instances, as many as 30% of patients need repeat surgeries get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer patients. [Image by MDO art director Matthew Claney] After his wife died of breast cancer in 2003, David Lee stepped away from […]

Filed Under: Diagnostics, Drug-Device Combinations, Featured, Imaging, Oncology, Pharmaceuticals, Surgical Tagged With: Lumicell

Medtech stories we missed this week: March 23, 2018

March 23, 2018 By Danielle Kirsh

missed-medtech-0323

From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with Innovasource. […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Grafts, Hospital Care, Imaging, Implants, Patient Monitoring, Regulatory/Compliance Tagged With: advantismedicalimaging, aziyobiologics, Balt, endospan, medizone, medtech, olympus, respiratorymotion

Medtech stories we missed this week: March 16, 2018

March 16, 2018 By Danielle Kirsh

missed medtech

From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Orthopedics, Regulatory/Compliance, Wound Care Tagged With: archtherapeutics, arthrex, cellrighttechnologies, enhatch, Guided Therapeutics, intricon, Life Spine Inc., medtech, unitedhealthproducts

FDA approves Bracco’s contrast agent for pediatric CNS imaging

January 30, 2018 By Sarah Faulkner

Bracco

The FDA has approved a label change to Bracco Diagnostics‘ MultiHance MRI contrast agent. The company’s product can now be used to visualize lesions with abnormal vascularity of the brain and spine in patients younger than two years old. Data collected in pediatric patients under the age of two showed that a dose of 0.05 […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Imaging, Neurological, Pediatrics, Regulatory/Compliance Tagged With: Bracco Diagnostics

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