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Wednesday, Aug 17, 2022

Senate Committee Passes Pack of Device Reform Bills

A cause dear to the hearts of medical device makers in Orange County and elsewhere—regulatory reform—is moving along in the U.S. Senate.

The Senate’s Health, Education, Labor and Pensions Committee passed three bills this month that addressed the matter and that are expected to be put into a comprehensive package mirroring the 21st Century Cures Act, which passed in the House of Representatives. Neither California senator co-sponsored the bills.

One bill, the Advancing Breakthrough Medical Devices for Patients Act of 2015, is designed to speed up the Food and Drug Administration’s path to approval for products “that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.”

The Combination Products Innovation Act of 2015 is intended to quicken the approval of products with drug and device elements through the FDA’s device pathway, which is less stringent than the one for drugs. It will allow companies to meet with the FDA within 30 days if regulators reject their combination products. The bill also requires the agency to provide justification if such a product isn’t designated as a medical device.

The last bill, the Medical Electronic Data Technology Enhancement for Consumers’ Health Act, excludes certain types of software from FDA regulations, although the agency had already released guidance that indicates it won’t regulate various software products.

Industry trade associations praised the committee’s work, while patient advocates were concerned that the bills don’t emphasize ensuring that medical products are safe and effective.

Dog Treatment Production Starts

Santa Ana-based VetCell Therapeutics said this month that it’s now producing a pair of advanced cell therapies for dogs with osteoarthritis.

ReGen OA is derived from a dog’s subcutaneous or abdominal adipose tissue, and EvoluGen OA is produced from plasma derived from a canine patient’s blood.

Both products are injected into dogs that suffer from the disease.

“Canine [osteoarthritis] is an extremely painful disease that unfortunately only gets worse with time if left untreated,” said Chad Maki, VetCell’s chief medical officer, in a news release. “Even though stem cell therapies designed to treat the symptoms and potentially reverse damage caused by the disease have been around for more than a decade, the number of suppliers has remained very low and production cost markup has left available therapies very expensive.”

VetCell is a unit of PrimeGen Biotech, a stem cell development company also based in Santa Ana.

Hoag Opens Irvine Facilities

Hoag Memorial Hospital Presbyterian opened a Hoag Urgent Care & Family Medicine location last week at the new Los Olivos Marketplace at Irvine Center Drive and the San Diego (I-405) Freeway in Irvine. Hoag Medical Group manages the center and provides its physicians. Services include on-site labs and X-ray imaging, and it has the capability to treat urgent or unexpected conditions ranging from the common cold and coughs to cuts and broken bones.

The Los Olivos location is the hospital’s ninth urgent care facility in Orange County. Hoag said it will open its 10th location soon at Hoag Health Center Irvine-Sand Canyon.

Hoag, with campuses in Newport Beach and Irvine, has two other urgent care centers in Irvine, plus centers in Aliso Viejo, Anaheim Hills, Huntington Beach, Huntington Harbour, Newport Beach and Tustin.

NVision Adds Orange Practice

Aliso Viejo-based NVision Eye Centers Inc. said it acquired the practice of Dr. Robert Ruper, an Orange eye surgeon. Terms were undisclosed.

NVision centers provide various vision correction procedures, including cataract surgery and custom laser-assisted in-situ keratomileusis, more commonly known as Lasik.

Ruper, a U.S. Air Force veteran, has practiced in Orange County since 1974. He established an outpatient surgical center at his medical office complex in 1993.

NVision President James Pereyra said Ruper’s practice was a “great asset” to the company, mentioning Ruper’s clinic and ambulatory surgery center in particular.

Bits & Pieces

Nihon Kohden America, an Irvine unit of Japan’s Nihon Kohden Corp., introduced new patient-monitoring alarm management and reporting software. Aware software is intended to help hospitals improve their alarm management and reduce alarm fatigue, and it’s connected with Nihon Kohden’s ReportKonnect technology. … Irvine-based Cylance Inc. made a presentation at the 2016 Health Information Management and Systems Society conference and exhibition last month in Las Vegas. The subject was “Threats in a Connected Health World.” … Anaheim-based ClearFlow Inc. said a study confirmed patients experienced reductions in post-operative atrial fibrillation and retained blood after being treated with its PleuraFlow Active Clearance Technology device. The data was published in the March edition of the Journal of Thoracic and Cardiovascular Surgery.


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