51.5 F
Laguna Hills
Thursday, Mar 28, 2024
-Advertisement-

Masimo Gets OK for Device That Moves With Patient

The Food and Drug Administration closed out June with a pair of approvals for an established Orange County medical device maker and a startup.

Irvine-based Masimo Corp. said it received 510 (k) clearance from the FDA for its Radius-7 patient monitor. The wearable, tetherless and noninvasive device contains Masimo’s signature rainbow technology and can monitor more than 10 parameters, including total hemoglobin.

Masimo said in a news release that total hemoglobin monitoring “has been shown to help clinicians provide more timely blood transfusions and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.”

Masimo Chief Executive Joe Kiani noted that Radius-7 works while a patient is fully mobile, a departure from previous monitors.

“Previous wearable patient monitors were hampered by a limited range of measurements and false alarms due to motion,” he said.

Separately, Lake Forest-based ReVision Optics Inc. announced that the FDA approved its Raindrop Near Vision Inlay implant.

Raindrop is a clear device made of a hydrogel material and resembles a tiny contact lens that’s smaller than the eye of a needle.

It’s implanted in the cornea of a patient’s nondominant eye in order to improve near vision in patients with presbyopia, which occurs in people 40 and older. Presbyopia is the loss of the ability to change the eye’s focusing power, resulting in diminished near vision.

ReVision said Raindrop is an elective surgical option for people who don’t want to wear bifocals or reading glasses, the most common way to correct presbyopia.

New St. Joseph Heritage COO

Irvine-based St. Joseph Health named Jill Duplechan chief operating officer of its St. Joseph Heritage Healthcare’s Southern California region.

St. Jude Heritage oversees five medical groups and five affiliated doctor networks in Orange County and the High Desert.

Duplechan succeeds Kevin Manemann, who became St. Jude Heritage’s chief executive earlier this year. She will oversee physician practice operations for all of St. Jude Heritage’s medical groups and affiliated physician networks.

She has more than 25 years of healthcare leadership experience, including serving as a chief administrative officer of Oakland-based Kaiser Permanente in the Riverside area.

The executive has a bachelor’s degree in healthcare management from the University of La Verne and a master of arts degree in organizational leadership from Chapman University in Orange. She also completed Harvard Business School’s executive leadership program.

Blueprint Bio Hires Exec

Edward Jensen is the new chief operating officer at Newport Beach-based Blueprint Bio Inc.

Blueprint, which received $7.5 million in funding last month from Murrieta-based Forentis Partners LLC, is developing biomarkers for use in personalized medicine. Biomarkers are measurable substances in an organism whose presence indicates disease, infection or environmental exposure.

Jensen has held senior leadership positions at several major drugmakers, including New Brunswick, N.J.-based Johnson & Johnson, Britain-based AstraZeneca PLC and Cambridge, Mass.-based Biogen Inc.

Lombard Device Debuts in Spain

Irvine-based Lombard Medical Inc. said late last month that its IntelliFlex LP device was used for the first time commercially in Europe with its launch in Spain.

Lombard makes devices to repair abdominal aortic aneurysms, or a ballooning of the body’s primary artery. IntelliFlex is used with the company’s Aorfix endovascular stent graft.

Lombard said in a statement that it plans to start shipping the devices this month to its direct markets in the United Kingdom and Germany and will do a full commercial launch in other European markets this year.

“We believe our portfolio approach with … Aorfix with IntelliFlex LP to treat complex anatomy and our new Altura stent graft, which delivers multiple advantages for the treatment of patients with more routine [abdominal aortic aneurysm] anatomy, will provide physicians with greater treatment options,” Chief Executive Simon Hubbert said.

Bits & Pieces

Irvine-based Nihon Kohden America, a unit of Japan’s Nihon Kohden Corp., said it signed a multiyear deal with the Arlington, Va.-based Association for the Advancement of Medical Instrumentation to advance the organization’s mission to promote the safe adoption and usage of healthcare technology. Nihon Kohden said in a news release that it would provide unspecified financial resources and employee participation in the association’s national coalitions for alarm management safety and promoting preparation for utilization of complex technology. … Anaheim-based Electronic Beam Engineering Inc. said Pleasanton-based Zeltiq Aesthetics Inc. selected it to weld the liquid-cooled heat exchange of its CoolSculpting device for noninvasive fat reduction.

Want more from the best local business newspaper in the country?

Sign-up for our FREE Daily eNews update to get the latest Orange County news delivered right to your inbox!

-Advertisement-

Featured Articles

-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-

Related Articles

-Advertisement-
-Advertisement-