Masimo Corp. (Nasdaq: MASI), the maker of patient-monitoring medical devices, on Feb. 13 won Food and Drug Administration clearance for its MightySat Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available over the counter without a prescription.
“Until now, consumers and even healthcare providers had no way of knowing what pulse oximeter they could trust to use at home,” Masimo Chief Executive Joe Kiani said in a statement.
“On the internet and even in drug stores, they are inundated with a myriad of products that are unreliable, with misleading advertisements about their abilities to provide accurate measurements of oxygen saturation and pulse rate.”
Consumers with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, lung cancer, flu or COVID-19, depend on accurate assessment of their arterial blood oxygen saturation that they can confidently share with their healthcare providers, Masimo said.
Edwards’ Evoque Valve System Recieves FDA OK
Edwards Lifesciences Corp. (NYSE: EW), Orange County’s most valuable medtech company, won Food and Drug Administration approval for key new product.
Edwards on Feb. 2 said the company’s Evoque tricuspid valve replacement system is the first transcatheter therapy to receive FDA approval for the treatment of tricuspid regurgitation.
The Evoque system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company’s bovine pericardial tissue.
The system “is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients,” said Dr. Susheel Kodali, a principal investigator in a study and director at the Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital.
“We see significant improvements in patients’ symptoms and quality of life, including not feeling short of breath and being able to care for themselves, which ranked highest on a patient preference survey.”
Shares jumped about 10% on the Feb. 2 news. At least 10 analysts boosted their target prices, anywhere from $86 to $100 each. At press time, shares were at $86.65 each with a $52 billion market cap, the second highest in Orange County among all public companies based here.
Edwards’ biggest unit focuses on the aortic valve while its fastest-growing and smallest unit is concentrating on the mitral and tricuspid valves.
As a result of the earlier-than-expected U.S. approval of Evoque, Edwards in its Feb. 6 earnings report increased its 2024 sales in its Transcatheter Mitral and Tricuspid Therapies unit to the high end of its prior $280 million to $320 million range, implying the unit’s growth might top 60% this year.