Cardiovascular Systems Inc. (CSI) reported the submission by its partner Innova Vascular Inc. of U.S. FDA premarket notification for thrombectomy devices to treat peripheral vascular disease. Already an acknowledge leader in atherectomy technologies, St. Paul, Minn.-based CSI intends to acquire and commercialize each device to expand its technology portfolio to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The U.S. FDA has granted Opticyte Inc. a breakthrough device designation for its Cell O2 patient monitor, a noninvasive technology for monitoring patients at risk of organ failure. The device could help to reduce serious illness and deaths by alerting clinicians to patients experiencing organ failure before irreversible damage occurs.
Citing federal preemption, the U.S. Court of Appeals for the First Circuit tossed multidistrict litigation (MDL) involving GSK plc’s labeling of Zofran, an antiemetic approved for postoperative use and in conjunction with chemo or radiation, but that is commonly used off-label in pregnancy.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
The U.S. FDA has granted Datar Cancer Genetics Inc. a breakthrough device designation for Trinetra-Glio, a blood test to help in the diagnosis of brain tumors.
The U.S. Department of Justice (DOJ) reported an indictment of three men alleged to have filed more than $100 million in genetic testing false claims directly or indirectly with the Medicare program. Two of the three defendants face as many as 65 years of incarceration if convicted, a clear sign that federal government agencies in the U.S. are more intent than ever on cracking down on fraud and abuse of federal health programs.
Imperative Care Inc. received U.S. FDA 510(k) clearance for its Zoom Rdl radial access system for treatment of ischemic strokes. The device is designed to enhance radial access for removal of clots in patients with tortuous anatomy and other challenges to the femoral access typically used, providing more options for both patients and physicians.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD – together known as early AD – from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
Playwright George Bernard Shaw is credited with coining the phrase, “better late than never,” a piece of advice the U.S. FDA seems to have taken to heart when it comes to posting the regulations for first-of-a-kind devices. The agency has posted eight regulations for de novo devices just between Jan. 4 and Jan. 5, 2023, five of those arriving on the latter of those two days in a post-holiday scramble to catch up.
Baxter International Inc. wasted no time in tackling its New Year’s resolution to trim down the business. On Friday morning, the company revealed details around the divestitures it foreshadowed in its third quarter 2022 earnings call with the announcement that it planned a tax-free spin off its Renal Care and Acute Therapies businesses into an independent, publicly traded company within the next 12 to 18 months.
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