Surmodics Inc. is poised to jump on the market for below the knee thrombectomy now that its Pounce platform with a low-profile (LP) model has FDA 510(k) clearance. The system can now effectively clear organized clots from vessels as small as 2 mm in diameter. The Pounce LP expands the Eden Prairie, Minn.-based company’s “grab-go-flow” platform. In its first iteration, Pounce enabled removal of thrombi and emboli in peripheral arteries 3.5 mm to 6 mm in diameter.
Seeking to repurpose a validated oncology drug target for atherosclerosis is Bitterroot Bio Inc., a biotech company that introduced itself to the world on the back of a sizable $145 million series A, funds it intends to use to advance its lead monoclonal antibody, BRB-002, toward the clinic.
Since late 2006, when hiked levels of aldosterone and increases in blood pressure foiled Pfizer Inc.’s torcetrapib, researchers have been wary of cholesteryl ester transfer protein (CETP) inhibitors. But not all researchers. Among the still-hopeful is Newamsterdam Pharma NV, which recently rolled out positive phase II data with obicetrapib, and the company is forging ahead despite other CETPs that have not fared well in late-stage testing after performing nicely in phase II, including candidates from Merck & Co. Inc. and Eli Lilly and Co.
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.
Pulse Medical Technology Inc. obtained breakthrough device designation from the FDA for its fourth generation μFR system, which would accelerate the commercialization of the device. “The fourth generation μFR system is currently not available on the market, but Pulse Medical is preparing for the marketing approval of the product in the U.S.,” Jingfeng Han, director of science division at Pulse Medical, told BioWorld.
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.
Thryv Therapeutics Inc. has announced the closing of a $5 million convertible note investment, the proceeds of which will be used to accelerate development of its pipeline, including preclinical programs in anaplastic thyroid carcinoma and atrial fibrillation.
The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023.
Startup Brightheart SAS raised €2 million (US$2.14 million) in seed financing, from Sofinnova Partners, that will allow the company to accelerate the development of its artificial intelligence software, which helps physicians detect congenital heart defects in fetuses. Brightheart hopes that the technology will improve the detection of complex congenital heart defects during prenatal ultrasound screening as intervening early could address fetal malformations or abnormalities and improve a baby’s chance of survival.
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